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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
The MP/RP group
The RP group
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;, Methylprednisolone, Ropivacaine, 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 tumour under general anaesthesia;
  • American Society of Anesthesiologists (ASA) physical status of I , II or III;
  • 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, methylprednisolone 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

The MP/RP group

The RP group

Arm Description

Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline;

Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline;

Outcomes

Primary Outcome Measures

Cumulative butorphanol consumption within 48 hours postoperatively
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.

Secondary Outcome Measures

The number of participants who have no butorphanol consumption
The number of participants who have not pushed the button of patient-controlled analgesia pump.
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 (NRS)
Pain will be assessed after surgery by 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 (RSS)
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.
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 opioids during the operation
The length of stay
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.
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

Full Information

First Posted
September 2, 2019
Last Updated
November 2, 2020
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04078139
Brief Title
Pre-emptive Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Postoperative Pain After Craniotomy
Official Title
Effects of Pre-emptive Scalp Infiltration With Ropivacaine and Methylprednisolone- Ropivacaine on Pain After Craniotomy in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2021 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

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
Yes

5. Study Description

Brief Summary
Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. 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. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) 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
Keywords
Postoperative Pain;, Post-Craniotomy;, Methylprednisolone, Ropivacaine, Scalp Infiltration

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
The MP/RP group
Arm Type
Experimental
Arm Description
Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline;
Arm Title
The RP group
Arm Type
Active Comparator
Arm Description
Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline;
Intervention Type
Drug
Intervention Name(s)
The MP/RP group
Intervention Description
Miscible liquid of methylprednisolone and ropivacaine in this study will be peri-incisional scalp infiltration with 40mg methylprednisolone, 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 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)
The RP group
Intervention Description
Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 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 butorphanol consumption within 48 hours postoperatively
Description
All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.
Time Frame
Within 48 hours after the operation
Secondary Outcome Measure Information:
Title
The number of participants who have no butorphanol consumption
Description
The number of participants who have not pushed the button of patient-controlled analgesia pump.
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 postoperatively
Title
Numerical rating scale (NRS)
Description
Pain will be assessed after surgery by 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 (RSS)
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
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 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
The total consumption of opioids during the operation
Description
The total consumption of opioids during the operation
Time Frame
During procedure
Title
The length of stay
Description
The duration of hospitalization after the operation
Time Frame
Approximately 2 weeks after the surgery
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
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 1 month 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 tumour under general anaesthesia; American Society of Anesthesiologists (ASA) physical status of I , II or III; 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, methylprednisolone 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Luo, M.D.
Phone
+86 13611326978
Email
13611326978@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chunmei Zhao, M.D.
Phone
+86 15510286930
Email
zhaochunmei1206@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
24535791
Citation
Gurbet A, Bekar A, Bilgin H, Ozdemir N, Kuytu T. Preemptive wound infiltration in lumbar laminectomy for postoperative pain: comparison of bupivacaine and levobupivacaine. Turk Neurosurg. 2014;24(1):48-53. doi: 10.5137/1019-5149.JTN.8431-13.0.
Results Reference
background
PubMed Identifier
16946657
Citation
Ersayli DT, Gurbet A, Bekar A, Uckunkaya N, Bilgin H. Effects of perioperatively administered bupivacaine and bupivacaine-methylprednisolone on pain after lumbar discectomy. Spine (Phila Pa 1976). 2006 Sep 1;31(19):2221-6. doi: 10.1097/01.brs.0000232801.19965.a0.
Results Reference
background
PubMed Identifier
20022457
Citation
Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty:a prospective, randomized trial. J Arthroplasty. 2010 Sep;25(6):851-7. doi: 10.1016/j.arth.2009.09.007. Epub 2009 Dec 21.
Results Reference
background
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
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
background
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
background
PubMed Identifier
19630495
Citation
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
background

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

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