- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04073069
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
April 24, 2022 updated by: Fang Luo, Beijing Tiantan Hospital
Pre-emptive Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative 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, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay, and mortality.
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 diprospan as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity in knee osteoarthritis or in total knee arthroplasty.
However, there has not been reported about local application of diprospan on scalp infiltration.
Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
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 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, diprospan 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 DR group
Participates received peri-incisional scalp infiltration with 15ml ropivacaine 1% wt/vol, 0.5ml diprospan, plus 14.5ml saline;
|
Miscible liquid of diprospan and ropivacaine in this study will be peri-incisional scalp infiltration with 0.5 ml diprospan, 15 ml 1% ropivacaine and 14.5 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 R group
Participates received peri-incisional scalp infiltration with 15ml ropivacaine 1% wt/vol, plus 15ml saline;
|
Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 15 ml 1% ropivacaine and 15 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 sufentanil 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 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
|
The total consumption of opioids during the operation
Time Frame: During procedure
|
The total consumption of opioids during the operation
|
During procedure
|
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
|
The number of participants who have no sufentanil 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
|
Patient satisfactory scale (PSS)
Time Frame: t 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
|
t 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 length of stay
Time Frame: Approximately 2 weeks after the operation
|
The duration of hospitalization after the operation
|
Approximately 2 weeks after the operation
|
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
- 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.
- Chaki T, Sugino S, Janicki PK, Ishioka Y, Hatakeyama Y, Hayase T, Kaneuchi-Yamashita M, Kohri N, Yamakage M. Efficacy and Safety of a Lidocaine and Ropivacaine Mixture for Scalp Nerve Block and Local Infiltration Anesthesia in Patients Undergoing Awake Craniotomy. J Neurosurg Anesthesiol. 2016 Jan;28(1):1-5. doi: 10.1097/ANA.0000000000000149.
- 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.
- Romsing J, Moiniche S, Ostergaard D, Dahl JB. Local infiltration with NSAIDs for postoperative analgesia: evidence for a peripheral analgesic action. Acta Anaesthesiol Scand. 2000 Jul;44(6):672-83. doi: 10.1034/j.1399-6576.2000.440607.x.
- Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.
- Watanabe K, Tokumine J, Yorozu T, Moriyama K, Sakamoto H, Inoue T. Particulate-steroid betamethasone added to ropivacaine in interscalene brachial plexus block for arthroscopic rotator cuff repair improves postoperative analgesia. BMC Anesthesiol. 2016 Oct 4;16(1):84. doi: 10.1186/s12871-016-0251-9.
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 (Actual)
September 3, 2019
Primary Completion (Actual)
August 15, 2020
Study Completion (Actual)
February 15, 2021
Study Registration Dates
First Submitted
August 27, 2019
First Submitted That Met QC Criteria
August 27, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
April 29, 2022
Last Update Submitted That Met QC Criteria
April 24, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY 2018-034-02-3
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
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.
Clinical Trials on Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on The DR group
-
Eurodiet Scandinavia ASCompletedObesity | Overweight | Metabolic SyndromeNorway
-
Centre Hospitalier Universitaire de NīmesDMS ApelemCompletedOsteodensitometryFrance
-
West German Center of Diabetes and HealthRecruiting
-
Military Medical Clinical Center of the Southern...Recruiting
-
University Hospital, MontpellierCompletedAortic Valve StenosisFrance
-
Beijing Tongren HospitalCompletedType 2 Diabetic RetinopathyChina
-
Duramed ResearchCompletedEndometriosisUnited States
-
Duramed ResearchCompletedStudy to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive BladderUrinary IncontinenceUnited States, Canada
-
LivaNovaCompletedAssess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.Italy, France, Spain, United States, Germany, United Kingdom
-
Second Affiliated Hospital, School of Medicine,...Unknown