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Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy

Primary Purpose

Pain, Postoperative, Post-Craniotomy Headache

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Miscible liquid of dexamethasone and ropivacaine
Ropivacaine
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Postoperative Pain, Post-Craniotomy Headache, Dexamethasone, Ropivacaine, Pre-emptive Scalp Infiltration

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for elective craniotomy for resection of a supratentorial tumour under general anaesthesia;
  • American Society of Anesthesiologists (ASA) physical status of I or II;
  • Participates required to fix their head in a head clamp intraoperatively;
  • Participates with an anticipated fully recovery within 2 hours postoperatively.

Exclusion Criteria:

  • History of craniotomy;
  • Expected delayed extubation or no plan to extubate;
  • Participants who cannot use a patient-controlled analgesia (PCA) device;
  • Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
  • Extreme body mass index (BMI) (< 15 or > 35);
  • Allergy to opioids, dexamethasone or ropivacaine;
  • History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
  • History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
  • Pregnant or at breastfeeding;
  • Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
  • Preoperative Glasgow Coma Scale< 15;
  • Suspicion of intracranial hypertension;
  • Peri-incisional infection;
  • Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.

Sites / Locations

  • Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexamethasone plus Ropivacaine group

Ropivacaine group

Arm Description

Participates received peri-incisional scalp infiltration of a miscible liquid of dexamethasone and ropivacaine. The local infiltration miscible liquid containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter

Participates received peri-incisional scalp infiltration of 5mg/mL ropivacaine.

Outcomes

Primary Outcome Measures

Cumulative sufentanil consumption within 48 hours postoperatively
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device in which the bolus dose of sufentanil will be set as 2 μg with a lockout interval of 10 min and the maximum dose will be limited as 8 μg per hour. If the participates feel inadequate analgesia after 5 times of sufentanil bolus, the bolus dose will be increased to 3 μg and the maximum dose will be increased to 12 μg per hour.

Secondary Outcome Measures

The number of participants who have no sufentanil consumption
The number of participants who have not pushed the button of patient-controlled analgesia pump. Both of the initial dose and background infusion of the patient-controlled analgesia pump in this study will be set as 0. Participates will be advised to push the analgesic demand button if they feel pain.
The first time to press the patient-controlled analgesia button
The first time that the participants press the patient-controlled analgesia button.
The total times that participants press patient-controlled analgesia button
The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
Numerical rating scale of pain
Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Postoperative nausea and vomiting
Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Ramsay Sedation Scale
Ramsey 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus
Respiratory depression
Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.
Heart rate
Mean arterial pressure
The times of emergency reducing blood pressure after the operation
The criteria for treatment is determined by the participant's surgeon in charge.The times of emergency reducing blood pressure will be recording by the investigator.
Patient satisfactory scale (PSS)
0 for unsatisfactory, and 10 for very satisfied
The total consumption of opioids during the operation
The total consumption of anaesthetic during the operation
The duration of hospitalization after the operation
The World Health Organization Quality of Life (WHOQOL)-BREF
Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.
Incisional related adverse events Incisional related adverse events
Including delayed incisional healing, incisional infection, intracranial infection, scar healing
Wound Healing Score
Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable
Patient and Observer Scar Assessment Scale
The Patient and Observer Scar Assessment Scale includes subjective symptoms of pain and pruritus and consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It assesses vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). and it incorporates patient assessments of pain, itching, color, stiffness, thickness, relief and overall opinion. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).

Full Information

First Posted
July 30, 2018
Last Updated
February 15, 2020
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03618264
Brief Title
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy
Official Title
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine vs. Ropivacaine for Relief of Postoperative Pain After Craniotomy in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
February 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. As a result, adequate pain control is essential for patients' prognosis and their postoperative life quality. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Thus, Investigators suppose that pre-emptive scalp infiltration with steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Post-Craniotomy Headache
Keywords
Postoperative Pain, Post-Craniotomy Headache, Dexamethasone, Ropivacaine, Pre-emptive Scalp Infiltration

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone plus Ropivacaine group
Arm Type
Experimental
Arm Description
Participates received peri-incisional scalp infiltration of a miscible liquid of dexamethasone and ropivacaine. The local infiltration miscible liquid containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter
Arm Title
Ropivacaine group
Arm Type
Active Comparator
Arm Description
Participates received peri-incisional scalp infiltration of 5mg/mL ropivacaine.
Intervention Type
Drug
Intervention Name(s)
Miscible liquid of dexamethasone and ropivacaine
Intervention Description
Intervention in this study will be peri-incisional scalp infiltration with dexamethasone, ropivacaine and normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Intervention in this study will be peri-incisional scalp infiltration with ropivacaine for participants who will undergo elective craniotomy. The local infiltration solution containing 5mg ropivacaine per milliliter will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
Primary Outcome Measure Information:
Title
Cumulative sufentanil consumption within 48 hours postoperatively
Description
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device in which the bolus dose of sufentanil will be set as 2 μg with a lockout interval of 10 min and the maximum dose will be limited as 8 μg per hour. If the participates feel inadequate analgesia after 5 times of sufentanil bolus, the bolus dose will be increased to 3 μg and the maximum dose will be increased to 12 μg per hour.
Time Frame
Within 48 hours after the operation
Secondary Outcome Measure Information:
Title
The number of participants who have no sufentanil consumption
Description
The number of participants who have not pushed the button of patient-controlled analgesia pump. Both of the initial dose and background infusion of the patient-controlled analgesia pump in this study will be set as 0. Participates will be advised to push the analgesic demand button if they feel pain.
Time Frame
Within 48 hours after the operation
Title
The first time to press the patient-controlled analgesia button
Description
The first time that the participants press the patient-controlled analgesia button.
Time Frame
Within 48 hours after the operation
Title
The total times that participants press patient-controlled analgesia button
Description
The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
Time Frame
Within 48 hours after the operation
Title
Numerical rating scale of pain
Description
Pain was assessed after surgery by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Time Frame
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery
Title
Postoperative nausea and vomiting
Description
Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Time Frame
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Title
Ramsay Sedation Scale
Description
Ramsey 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus
Time Frame
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Title
Respiratory depression
Description
Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.
Time Frame
Within 48 hours after the operation
Title
Heart rate
Time Frame
Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Title
Mean arterial pressure
Time Frame
Before anesthesia induction, after anesthesia induction, after scalp infiltration, during skull drilling, mater cutting, skin closure and at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
Title
The times of emergency reducing blood pressure after the operation
Description
The criteria for treatment is determined by the participant's surgeon in charge.The times of emergency reducing blood pressure will be recording by the investigator.
Time Frame
Within 48 hours after the operation
Title
Patient satisfactory scale (PSS)
Description
0 for unsatisfactory, and 10 for very satisfied
Time Frame
At 48 hours, 1 week, 1 month, 3 months and 6 months after surgery
Title
The total consumption of opioids during the operation
Time Frame
During procedure
Title
The total consumption of anaesthetic during the operation
Time Frame
During procedure
Title
The duration of hospitalization after the operation
Time Frame
Approximately 2 weeks after the operation
Title
The World Health Organization Quality of Life (WHOQOL)-BREF
Description
Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.
Time Frame
At 1 month, 3 months and 6 months after surgery
Title
Incisional related adverse events Incisional related adverse events
Description
Including delayed incisional healing, incisional infection, intracranial infection, scar healing
Time Frame
Within 1 month after surgery
Title
Wound Healing Score
Description
Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable
Time Frame
At 3 weeks and 6 weeks after surgery
Title
Patient and Observer Scar Assessment Scale
Description
The Patient and Observer Scar Assessment Scale includes subjective symptoms of pain and pruritus and consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It assesses vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). and it incorporates patient assessments of pain, itching, color, stiffness, thickness, relief and overall opinion. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).
Time Frame
At 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for elective craniotomy for resection of a supratentorial tumour under general anaesthesia; American Society of Anesthesiologists (ASA) physical status of I or II; Participates required to fix their head in a head clamp intraoperatively; Participates with an anticipated fully recovery within 2 hours postoperatively. Exclusion Criteria: History of craniotomy; Expected delayed extubation or no plan to extubate; Participants who cannot use a patient-controlled analgesia (PCA) device; Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery; Extreme body mass index (BMI) (< 15 or > 35); Allergy to opioids, dexamethasone or ropivacaine; History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects; History of psychiatric disorders, uncontrolled epilepsy or chronic headache; Pregnant or at breastfeeding; Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes; Preoperative Glasgow Coma Scale< 15; Suspicion of intracranial hypertension; Peri-incisional infection; Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Luo, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25903913
Citation
Rocha-Filho PA. Post-craniotomy headache: a clinical view with a focus on the persistent form. Headache. 2015 May;55(5):733-8. doi: 10.1111/head.12563. Epub 2015 Apr 22.
Results Reference
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PubMed Identifier
29456348
Citation
Vallapu S, Panda NB, Samagh N, Bharti N. Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthetic Agent in Scalp Block and Scalp Infiltration to Control Postcraniotomy Pain: A Double-Blind Randomized Trial. J Neurosci Rural Pract. 2018 Jan-Mar;9(1):73-79. doi: 10.4103/jnrp.jnrp_310_17.
Results Reference
background
PubMed Identifier
27996204
Citation
Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.
Results Reference
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PubMed Identifier
28299313
Citation
Chowdhury T, Garg R, Sheshadri V, Venkatraghavan L, Bergese SD, Cappellani RB, Schaller B. Perioperative Factors Contributing the Post-Craniotomy Pain: A Synthesis of Concepts. Front Med (Lausanne). 2017 Mar 1;4:23. doi: 10.3389/fmed.2017.00023. eCollection 2017.
Results Reference
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PubMed Identifier
28183036
Citation
Akcil EF, Dilmen OK, Vehid H, Ibisoglu LS, Tunali Y. Which one is more effective for analgesia in infratentorial craniotomy? The scalp block or local anesthetic infiltration. Clin Neurol Neurosurg. 2017 Mar;154:98-103. doi: 10.1016/j.clineuro.2017.01.018. Epub 2017 Jan 30.
Results Reference
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PubMed Identifier
27604271
Citation
Dunn LK, Naik BI, Nemergut EC, Durieux ME. Post-Craniotomy Pain Management: Beyond Opioids. Curr Neurol Neurosci Rep. 2016 Oct;16(10):93. doi: 10.1007/s11910-016-0693-y.
Results Reference
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PubMed Identifier
20479664
Citation
Mordhorst C, Latz B, Kerz T, Wisser G, Schmidt A, Schneider A, Jahn-Eimermacher A, Werner C, Engelhard K. Prospective assessment of postoperative pain after craniotomy. J Neurosurg Anesthesiol. 2010 Jul;22(3):202-6. doi: 10.1097/ANA.0b013e3181df0600.
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Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689.
Results Reference
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PubMed Identifier
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Citation
Misra S, Koshy T, Suneel PR. Oral clonidine attenuates the fall in mean arterial pressure due to scalp infiltration with epinephrine-lidocaine solution in patients undergoing craniotomy: a prospective, randomized, double-blind, and placebo controlled trial. J Neurosurg Anesthesiol. 2009 Oct;21(4):297-301. doi: 10.1097/ANA.0b013e3181ac7a31.
Results Reference
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PubMed Identifier
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Citation
Zhao C, Wang S, Pan Y, Ji N, Luo F. Pre-Emptive Incision-Site Infiltration with Ropivacaine Plus Dexamethasone for Postoperative Pain After Supratentorial Craniotomy: A Prospective Randomized Controlled Trial. J Pain Res. 2021 Apr 19;14:1071-1082. doi: 10.2147/JPR.S300943. eCollection 2021.
Results Reference
derived

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Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Postoperative Pain After Craniotomy

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