NCT05108337

Brief Summary

The incidence of postoperative chronic pain after craniotomy is high. Postoperative chronic pain seriously affects patient's quality of life. 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 incidence of chronic pain after craniotomy via suboccipital retrosigmoid approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

October 21, 2021

Last Update Submit

January 20, 2024

Conditions

Neurosurgery

Keywords

Cervical Plexus BlockChronic painNeurosurgery

Outcome Measures

Primary Outcomes (1)

  • Chronic pain assessment

    Follow-up visit will be conducted by telephone at 3 months after surgery.

    at 3 months after surgery.

Study Arms (2)

Scpb group

EXPERIMENTAL

Superficial cervical plexus block group

Procedure: Superficial cervical plexus block

Control group

SHAM COMPARATOR

Saline group

Other: Control group

Interventions

Superficial cervical plexus blockPROCEDURE

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 0.5% ropinacaine.

Scpb group
Control groupOTHER

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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
MD,PhD

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 4, 2021

Study Start

November 4, 2021

Primary Completion

November 22, 2023

Study Completion

November 22, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

CN(2)