Superficial Cervical Plexus Block for Postoperative Chronic Pain

NCT ID: NCT05108337

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2023-11-22

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.

Conditions

Neurosurgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Scpb group

Superficial cervical plexus block group

Group Type: EXPERIMENTAL

Superficial cervical plexus block

Intervention Type: PROCEDURE

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.

Control group

Saline 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

Superficial cervical plexus block

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.

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

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: Yes

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuming Peng

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2021-10-16

Identifier Type: -

Identifier Source: org_study_id