Superficial Cervical Plexus Block for Postoperative Analgesia

NCT04036812 | Completed

• 1 other identifier: 2019-06-29
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Plexus Block;Analgesia;Neurosurgery

Outcome Measures

Primary Outcomes (1)

• the cumulative consumption of sufentanil by the PCA

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

  24 hours after surgery

Secondary Outcomes (4)

• Use of analgesics by the PCA after operation

  at 1, 2, 4, 48 hours after surgery.

• Pain severity score

  at 1, 2, 4, 24, 48 hours after surgery

• Anesthesia recovery quality score：

  at 1 hour after surgery

• Patient analgesic satisfaction

  at 24 hours after surgery

Study Arms (2)

Superficial cervical plexus block group

EXPERIMENTAL

Procedure: Superficial cervical plexus block

Control group

SHAM COMPARATOR

Other: Control group

Interventions

Superficial cervical plexus block PROCEDURE

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

Superficial cervical plexus block group

Control group 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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing TianTan Hospital

Beijing, 100070, China

Location

Related Publications (2)

• 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.

  PMID: 35768167 DERIVED

• 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.

  PMID: 32029493 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yuming Peng, M.D.

  Beijing Tian Tan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: November 18, 2019
• Primary Completion: April 9, 2021
• Study Completion: April 10, 2021
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CN (2)