Superficial Cervical Plexus Block for Postoperative Analgesia

NCT ID: NCT04036812

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Plexus Block;Analgesia;Neurosurgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Superficial cervical plexus block group

Group Type EXPERIMENTAL

Superficial cervical plexus block

Intervention Type PROCEDURE

superficial cervical plexus nerve block will be performed under the guidance of ultrasound

Control group

Group Type SHAM_COMPARATOR

Control group

Intervention Type OTHER

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.

Interventions

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Superficial cervical plexus block

superficial cervical plexus nerve block will be performed under the guidance of ultrasound

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuming Peng

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuming Peng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tian Tan Hospital, Capital Medical University

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing TianTan Hospital

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 35768167 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32029493 (View on PubMed)

Other Identifiers

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2019-06-29

Identifier Type: -

Identifier Source: org_study_id

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