Superficial Cervical Plexus Block for Postoperative Chronic Pain

Study Overview
=================
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.

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

Conditions
-----------------
Neurosurgery

Intervention / Treatment
-----------------
* Procedure: Superficial cervical plexus block
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective suboccipital retrosigmoid approach approach craniotomy; Age between 18 and 65 years; American Society of Anesthesiologists (ASA) physical status I-III. Exclusion Criteria: 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scpb group<br>Superficial cervical plexus block group | Procedure: Superficial cervical plexus block<br>* 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.<br>|
| Sham Comparator: Control group<br>Saline group | Other: Control group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain assessment | Follow-up visit will be conducted by telephone at 3 months after surgery. | at 3 months after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Plexus Block, Chronic pain, Neurosurgery