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

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

Study Locations

      • Beijing, China, 100070
        • Completed
        • Beijing Tiantan Hospital
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
          • Yuming Peng, M.D.

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:

  1. Elective suboccipital retrosigmoid approach approach craniotomy;
  2. Age between 18 and 65 years;
  3. American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion Criteria:

  1. The patients or legal clients refuse to provide informed consent;
  2. Local infection;
  3. Preoperative impairment of consciousness and cognitive function;
  4. Uncontrolled hypertension;
  5. Inability to communicate;
  6. Allergies to experimental drugs;
  7. History of drug abuse;
  8. History of chronic headache;
  9. Aphasia and hearing impairment;
  10. Patients undergoing second craniotomy;
  11. 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.
Experimental: Superficial cervical plexus block group
superficial cervical plexus nerve block will be performed under the guidance of ultrasound

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
the cumulative consumption of sufentanil by the PCA 24 hours after surgery
24 hours after surgery

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.
the cumulative consumption of sufentanil by PCA
at 1, 2, 4, 48 hours after surgery.
Pain severity score
Time Frame: at 1, 2, 4, 24, 48 hours after surgery
It will be accessed using NRS
at 1, 2, 4, 24, 48 hours after surgery
Anesthesia recovery quality score:
Time Frame: at 1 hour after surgery
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.
at 1 hour after surgery
Patient analgesic satisfaction
Time Frame: at 24 hours after surgery
Patient satisfaction with overall pain management will be evaluated at 24 hours after surgery using NRS
at 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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