Superficial Cervical Plexus Block for Postoperative Chronic Pain

Neurosurgery Clinical Trial

Official title:

Ultrasound Guided Superficial Cervical Plexus Block for Chronic Pain After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108337
• Other study ID #: 2021-10-16
• Status: Completed
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: November 22, 2023

Study information

• Verified date: January 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: November 22, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Pain
• Neurosurgery

Intervention

Procedure:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain assessment	Follow-up visit will be conducted by telephone at 3 months after surgery.	at 3 months after surgery.