- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078139
Pre-emptive Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Postoperative Pain After Craniotomy
November 2, 2020 updated by: Fang Luo, Beijing Tiantan Hospital
Effects of Pre-emptive Scalp Infiltration With Ropivacaine and Methylprednisolone- Ropivacaine on Pain After Craniotomy in Adults
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
188
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fang Luo, M.D.
- Phone Number: +86 13611326978
- Email: 13611326978@163.com
Study Contact Backup
- Name: Chunmei Zhao, M.D.
- Phone Number: +86 15510286930
- Email: zhaochunmei1206@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Beijing Tiantan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The MP/RP group
Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline;
|
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.
|
Active Comparator: The RP group
Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline;
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative butorphanol consumption within 48 hours postoperatively
Time Frame: Within 48 hours after the operation
|
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.
|
Within 48 hours after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of participants who have no butorphanol consumption
Time Frame: Within 48 hours after the operation
|
The number of participants who have not pushed the button of patient-controlled analgesia pump.
|
Within 48 hours after the operation
|
The first time to press the patient-controlled analgesia button
Time Frame: Within 48 hours after the operation
|
The first time that the participants press the patient-controlled analgesia button.
|
Within 48 hours after the operation
|
The total times that participants press patient-controlled analgesia button
Time Frame: Within 48 hours postoperatively
|
The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
|
Within 48 hours postoperatively
|
Numerical rating scale (NRS)
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
|
Pain will be assessed after surgery by numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
|
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
|
Postoperative nausea and vomiting
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
|
Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
|
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
|
Ramsay Sedation Scale (RSS)
Time Frame: At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
|
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.
|
At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery
|
Respiratory depression
Time Frame: Within 48 hours after the operation
|
Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.
|
Within 48 hours after the operation
|
The times of emergency reducing blood pressure after the operation
Time Frame: Within 48 hours 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.
|
Within 48 hours after the operation
|
Patient satisfactory scale (PSS)
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
|
0 for unsatisfactory, and 10 for very satisfied
|
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
|
The total consumption of opioids during the operation
Time Frame: During procedure
|
The total consumption of opioids during the operation
|
During procedure
|
The length of stay
Time Frame: Approximately 2 weeks after the surgery
|
The duration of hospitalization after the operation
|
Approximately 2 weeks after the surgery
|
The World Health Organization Quality of Life (WHOQOL)-BREF
Time Frame: At 1 month, 3 months and 6 months after surgery
|
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.
|
At 1 month, 3 months and 6 months after surgery
|
Wound Healing Score
Time Frame: At 1 month after surgery
|
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
|
At 1 month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 5, 2021
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
September 2, 2019
First Submitted That Met QC Criteria
September 2, 2019
First Posted (Actual)
September 4, 2019
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY 2018-034-02-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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