Back to resultsScalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexamethasone lipid microsphere plus ropivacaine
Ropivacaine alone
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for elective craniotomy under general anesthesia;
- Age 18-64 years;
- American Society of Anesthesiologists (ASA) physical status of I or II;
- Anticipated tracheal extubation, full recovery and cooperation within 2 hours postoperatively
- Patients required to fix their head in a head clamp during the operation.
Exclusion Criteria:
- Previous history of craniotomy;
- Plan to delay extubation or no plan to extubate;
- Patients who cannot use the patient-controlled analgesia (PCA) device;
- Patients who cannot comprehend the instructions of a numeric rating scale (NRS) before craniotomy;
- Body mass index (BMI) <15 or >35;
- Allergy to dexamethasone, lipid microsphere, opioids or ropivacaine;
- History of drug abuse or excessive alcohol, chronic opioids use (more than 2 weeks), or use of any sedative or analgesic before surgery;
- History of uncontrolled epilepsy, psychiatric disorders or chronic headache;
- Pregnant or at breastfeeding;
- Symptomatic cardiopulmonary, liver or renal dysfunction or combined with diabetes or other systemic dysfunction;
- Glasgow Coma Scale <15 before the surgery;
- Intracranial hypertension;
- Peri-incisional infection;
- Patients who have received chemoradiotherapy before the surgery or expected to receive postoperative chemoradiotherapy according to the preoperative imaging.
Sites / Locations
- Beijing Tiantan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The dexamethasone lipid microsphere plus ropivacaine group
The ropivacaine alone group
Arm Description
Outcomes
Primary Outcome Measures
The pain NRS scores at 24 h after craniotomy
The numeral rating scale allows a person to describe the intensity of the pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be".
Secondary Outcome Measures
The first time the patients press the PCA button
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
The number of patients who didn't press the PCA button
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
The number of times patients press the PCA button
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
The NRS score
The numeral rating scale allows a person to describe the intensity of the pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be".
The incidence of PONV
Postoperative nausea and vomiting: 0 represents absent; 1 represents nausea without treatment; 2 represents nausea in need of treatment; 3 represents vomiting
Time to first rescue analgesia with OC/APAP after surgery
Patients will be given an oral supplementary tablet of oxycodone (OC)/acetaminophen (APAP) 5/325-mg (MallinckrodtInc.USA) for rescue analgesia when NRS score > 4 after receiving four times of bolus with the PCA device. OC/ APAP will be prescribed at an interval of at least 6 h until the end of our study.
Duration of hospitalization
From the date of the surgery until the date of discharge
WHOQOL-BREF scores
The World Health Organization QoL abbreviated version scale consists of 26 items and involves 4 aspects: A. Physical health (7 items); B. Psychological health (6 items); C. Social relationships (3 items); D. Environment (8 items). Other two items measure the patients' quality of life and general health. The average score for each domain can range from 4 to 20, and the higher the score, the better the quality of life.
Wound healing scores
Wound healing scores： 1 represents skin fully healed, no infection, hair regrowth along wound; 2 represents skin ≤3cm in total not healed, ≤0.5cm margin of redness, hair ≤3cm not regrowthing; 3 represents skin >3cm not healed, more redness or superficial pus, >3-6cm not regrowthing hair; 4 represents areas of necrosis ≤3cm, deep infection, >6cm not regrowthing hair; 5 represents areas of necrosis >3cm.
POSAS scores
The Patient and Observer Scar Assessment Scale consists of two scales: the observer scale and the patient scale. Both scales contain six items that are scored numerically. Each of the six items on both scales has a 10-step score, with 10 indicating the worst imaginable scar or sensation. The total score of both scales consists of adding the scores of each of the six items (range, 6 to 60). The lowest score, 6, reflects normal skin, whereas the highest score, 60, reflects the worst imaginable scar.
Adverse events
Steroid-hormone related complications, such as wound infection, wound edema, delayed wound healing, pulmonary infections, gastric ulcers, local atrophy or infection, embolic events and so on
Cumulative sufentanil consumption by PCA device
A Patient Controlled Analgesia (PCA) device containing sufentanil 200μg and ondansetron 16 mg in 100 ml saline will be set up to deliver 1 mL as an intravenous bolus with a 10-min lockout interval after craniotomy. The maximum dose will be limited to 8 μg per hour, and there will be no initial dose or background infusion. Patients will be advised to push the analgesic demand button if they feel pain and to repeat it until the pain is relieved.
Full Information
NCT ID
NCT04488315
First Posted
July 19, 2020
Last Updated
November 3, 2022
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04488315
Brief Title
Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain
Official Title
Pre-emptive Scalp Infiltration With Dexamethasone Lipid Microsphere Plus Ropivacaine for Postoperative Pain After Craniotomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (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
According to recent studies, patients following craniotomy suffer more than minimal pain; two-thirds of patients experienced moderate to severe pain. Postoperative pain most often occurs within 48 hours after surgery. Local infiltration of anesthesia is the most simple and effective analgesia. However, the analgesic effect only lasts for a short-time after surgery, and it cannot adequately meet the needs of postoperative analgesia after craniotomy. Several studies have shown that the mixture of dexamethasone with local anesthetics could reduce the postoperative pain scores better than local anesthetics alone. Lipid microsphere is a relatively new drug delivery system. It is an artificial lipid emulsion. Studies have shown that dexamethasone lipid microsphere, the dexamethasone palmitate emulsion (D-PAL emulsion), has stronger anti-inflammatory effect than dexamethasone. Therefore, the investigators hypothesize that the pre-emptive scalp infiltration with dexamethasone lipid microsphere plus ropivacaine could achieve superior postoperative pain-relief compared to ropivacaine alone for patients undergoing craniotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The dexamethasone lipid microsphere plus ropivacaine group
Arm Type
Experimental
Arm Title
The ropivacaine alone group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone lipid microsphere plus ropivacaine
Other Intervention Name(s)
ropivacaine plus D-PAL
Intervention Description
Local scalp infiltration solution will consist of 30ml miscible liquids containing 8 mg dexamethasone lipid microsphere, 150mg ropivacaine and normal saline.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine alone
Intervention Description
Local scalp infiltration solution will consist of 30ml miscible liquids containing 150mg ropivacaine and normal saline
Primary Outcome Measure Information:
Title
The pain NRS scores at 24 h after craniotomy
Description
The numeral rating scale allows a person to describe the intensity of the pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be".
Time Frame
At 24 hours after the operation
Secondary Outcome Measure Information:
Title
The first time the patients press the PCA button
Description
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
Time Frame
Within 24, 48,72 hours postoperatively
Title
The number of patients who didn't press the PCA button
Description
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
Time Frame
Within 24, 48, 72 hours postoperatively
Title
The number of times patients press the PCA button
Description
Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. The PCA device will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.
Time Frame
Within 24, 48, 72 hours postoperatively
Title
The NRS score
Description
The numeral rating scale allows a person to describe the intensity of the pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be".
Time Frame
At 2 hours, 4 hours, 12 hours, 48 hours, 72 hours, 1 month, and 3 months after the operation
Title
The incidence of PONV
Description
Postoperative nausea and vomiting: 0 represents absent; 1 represents nausea without treatment; 2 represents nausea in need of treatment; 3 represents vomiting
Time Frame
Within 24, 48, 72 hours after surgery
Title
Time to first rescue analgesia with OC/APAP after surgery
Description
Patients will be given an oral supplementary tablet of oxycodone (OC)/acetaminophen (APAP) 5/325-mg (MallinckrodtInc.USA) for rescue analgesia when NRS score > 4 after receiving four times of bolus with the PCA device. OC/ APAP will be prescribed at an interval of at least 6 h until the end of our study.
Time Frame
At 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
Title
Duration of hospitalization
Description
From the date of the surgery until the date of discharge
Time Frame
From the date of the surgery until the date of discharge, assesses up to 7 days
Title
WHOQOL-BREF scores
Description
The World Health Organization QoL abbreviated version scale consists of 26 items and involves 4 aspects: A. Physical health (7 items); B. Psychological health (6 items); C. Social relationships (3 items); D. Environment (8 items). Other two items measure the patients' quality of life and general health. The average score for each domain can range from 4 to 20, and the higher the score, the better the quality of life.
Time Frame
At 1 month and 3 months after surgery
Title
Wound healing scores
Description
Wound healing scores： 1 represents skin fully healed, no infection, hair regrowth along wound; 2 represents skin ≤3cm in total not healed, ≤0.5cm margin of redness, hair ≤3cm not regrowthing; 3 represents skin >3cm not healed, more redness or superficial pus, >3-6cm not regrowthing hair; 4 represents areas of necrosis ≤3cm, deep infection, >6cm not regrowthing hair; 5 represents areas of necrosis >3cm.
Time Frame
At 1 and 3 months after surgery
Title
POSAS scores
Description
The Patient and Observer Scar Assessment Scale consists of two scales: the observer scale and the patient scale. Both scales contain six items that are scored numerically. Each of the six items on both scales has a 10-step score, with 10 indicating the worst imaginable scar or sensation. The total score of both scales consists of adding the scores of each of the six items (range, 6 to 60). The lowest score, 6, reflects normal skin, whereas the highest score, 60, reflects the worst imaginable scar.
Time Frame
At 3 months after surgery
Title
Adverse events
Description
Steroid-hormone related complications, such as wound infection, wound edema, delayed wound healing, pulmonary infections, gastric ulcers, local atrophy or infection, embolic events and so on
Time Frame
Through the whole follow-up, an average of 3 months
Title
Cumulative sufentanil consumption by PCA device
Description
A Patient Controlled Analgesia (PCA) device containing sufentanil 200μg and ondansetron 16 mg in 100 ml saline will be set up to deliver 1 mL as an intravenous bolus with a 10-min lockout interval after craniotomy. The maximum dose will be limited to 8 μg per hour, and there will be no initial dose or background infusion. Patients will be advised to push the analgesic demand button if they feel pain and to repeat it until the pain is relieved.
Time Frame
During 24hours, 48 hours and 72 hours postoperatively
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 under general anesthesia;
Age 18-64 years;
American Society of Anesthesiologists (ASA) physical status of I or II;
Anticipated tracheal extubation, full recovery and cooperation within 2 hours postoperatively
Patients required to fix their head in a head clamp during the operation.
Exclusion Criteria:
Previous history of craniotomy;
Plan to delay extubation or no plan to extubate;
Patients who cannot use the patient-controlled analgesia (PCA) device;
Patients who cannot comprehend the instructions of a numeric rating scale (NRS) before craniotomy;
Body mass index (BMI) <15 or >35;
Allergy to dexamethasone, lipid microsphere, opioids or ropivacaine;
History of drug abuse or excessive alcohol, chronic opioids use (more than 2 weeks), or use of any sedative or analgesic before surgery;
History of uncontrolled epilepsy, psychiatric disorders or chronic headache;
Pregnant or at breastfeeding;
Symptomatic cardiopulmonary, liver or renal dysfunction or combined with diabetes or other systemic dysfunction;
Glasgow Coma Scale <15 before the surgery;
Intracranial hypertension;
Peri-incisional infection;
Patients who have received chemoradiotherapy before the surgery or expected to receive postoperative chemoradiotherapy 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.
Organizational Affiliation
Beijing Tian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Zhang, MD
Organizational Affiliation
Beijing Tian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Luo, M.D.
Phone
+86 13611326978
Email
13611326978@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
27512639
Citation
Zhou H, Ou M, Yang Y, Ruan Q, Pan Y, Li Y. Effect of skin infiltration with ropivacaine on postoperative pain in patients undergoing craniotomy. Springerplus. 2016 Jul 26;5(1):1180. doi: 10.1186/s40064-016-2856-3. eCollection 2016.
Results Reference
background
PubMed Identifier
17410701
Citation
Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
Results Reference
background
PubMed Identifier
31213883
Citation
Jia Y, Zhao C, Ren H, Wang T, Luo F. Pre-emptive scalp infiltration with dexamethasone plus ropivacaine for postoperative pain after craniotomy: a protocol for a prospective, randomized controlled trial. J Pain Res. 2019 May 24;12:1709-1719. doi: 10.2147/JPR.S190679. eCollection 2019.
Results Reference
background
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Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-craniotomy Pain
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