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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05108337
Other study ID # 2021-10-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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.
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