- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04036812
Superficial Cervical Plexus Block for Postoperative Analgesia
September 9, 2021 updated by: Yuming Peng, Beijing Tiantan Hospital
Ultrasound Guided Superficial Cervical Plexus Block for Analgesia After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
The incidence of postoperative pain after craniotomy is high.
Severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients.
Compound local scalp nerve block is a good choice for analgesia after craniotomy.
However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block.
Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach.
At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture.
The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the requirement of analgesic drugs and pain after craniotomy via suboccipital retrosigmoid approach.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
106
Phase
- Not Applicable
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: Yuming Peng, M.D.
- Phone Number: 010-59976658
- Email: florapym766@163.com
Study Locations
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-
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Beijing, China, 100070
- Completed
- Beijing Tiantan Hospital
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Beijing
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Beijing, Beijing, China, 100050
- Recruiting
- Beijing Tiantan Hospital
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Contact:
- Yuming Peng, M.D.
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-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elective suboccipital retrosigmoid approach approach craniotomy;
- Age between 18 and 65 years;
- American Society of Anesthesiologists (ASA) physical status I-III.
Exclusion Criteria:
- The patients or legal clients refuse to provide informed consent;
- Local infection;
- Preoperative impairment of consciousness and cognitive function;
- Uncontrolled hypertension;
- Inability to communicate;
- Allergies to experimental drugs;
- History of drug abuse;
- History of chronic headache;
- Aphasia and hearing impairment;
- Patients undergoing second craniotomy;
- Body mass index < 18.5 kg/m2 or > 35.0 kg/m2;
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control group
|
ultrasound guidance will be used to determine the location of superficial cervical plexus nerve.
The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline.
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Experimental: Superficial cervical plexus block group
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superficial cervical plexus nerve block will be performed under the guidance of ultrasound
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the cumulative consumption of sufentanil by the PCA
Time Frame: 24 hours after surgery
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the cumulative consumption of sufentanil by the PCA 24 hours after surgery
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24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of analgesics by the PCA after operation
Time Frame: at 1, 2, 4, 48 hours after surgery.
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the cumulative consumption of sufentanil by PCA
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at 1, 2, 4, 48 hours after surgery.
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Pain severity score
Time Frame: at 1, 2, 4, 24, 48 hours after surgery
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It will be accessed using NRS
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at 1, 2, 4, 24, 48 hours after surgery
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Anesthesia recovery quality score:
Time Frame: at 1 hour after surgery
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It will be accessed at postoperative 1 and 2 hours using the Anesthesia Steward Emergence Scale.
The Anesthesia Steward Emergence Scale(0-6) is divided into three parts: the degree of wakefulness - 2 points for complete recovery, 1 point for response to stimulation, 0 point for no response to stimulation; the degree of airway patency - 2 points for cough according to the doctor's order, 1 point for maintenance of airway patency without support, 0 point for support required for respiratory tract; 2 points for conscious activities of limbs with limb mobility, 1 point for unconscious activities of limbs, point for no activities of limbs.
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at 1 hour after surgery
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Patient analgesic satisfaction
Time Frame: at 24 hours after surgery
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Patient satisfaction with overall pain management will be evaluated at 24 hours after surgery using NRS
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at 24 hours after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuming Peng, M.D., Beijing Tian Tan Hospital, Capital Medical University
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
- Zeng M, Li R, Xu X, Wang D, Dong J, Li S, Kass IS, Peng Y, Jia W. Ultrasound-guided superficial cervical plexus block reduces opioid consumption in patients undergoing craniotomy via suboccipital retrosigmoid approach: a randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 29:rapm-2022-103534. doi: 10.1136/rapm-2022-103534. Online ahead of print.
- Peng K, Zeng M, Dong J, Yan X, Wang D, Li S, Peng Y. Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 5;10(2):e034003. doi: 10.1136/bmjopen-2019-034003.
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)
November 18, 2019
Primary Completion (Anticipated)
March 8, 2022
Study Completion (Anticipated)
March 8, 2022
Study Registration Dates
First Submitted
July 26, 2019
First Submitted That Met QC Criteria
July 26, 2019
First Posted (Actual)
July 30, 2019
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 9, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-06-29
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.
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