Effect of Scalp Nerve Block on the Recovery Quality of Parkinson's Patients After Deep Brain Stimulation

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Other: scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine

• Registration Number: NCT05353764
• Lead Sponsor: Changhai Hospital

Brief Summary

Patients diagnosed with Parkinson's disease (PD) undergoing deep Brain Stimulation (DBS) have a higher risk of perioperative complications and postoperative pain will affect quality of recovery (QoR) resulting in longer hospitalization time and higher hospital costs. Scalp nerve block (SNB) combined with intercostal nerve block (ICNB)can alleviate postoperative pain while effect of them on postoperative recovery quality of patients diagnosed with PD was unclear. Therefore, the investigators conducted a randomized controlled trails to provide a novel method for enhanced recovery and early prevention and treatment of acute pain after DBS surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-19
• Study Start: 2022-04-20
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-24
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• patients with PD who receive elective deep brain stimulation (DBS) surgery
• Aged ≥ 18
• American Society of Anesthesiologists (ASA) physical status of I-III
• Able to communicate normally

Exclusion Criteria

• Allergy to local anesthetics
• Pre-existing infection at block site
• Severe coagulopathy
• Pre-existing neuropathic pain condition
• Previous history of DBS surgery
• unwilling to provide informed consent or poor compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SNB group	scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine	patients in the SNB group will receive general anesthesia combined with scalp nerve block and intercostal nerve block with 0.5% ropivacaine.

Primary Outcome Measures

Name	Time	Method
The 15-item QoR score	24 hour after surgery	The 15-item QoR score is used to asses quality of recovery after surgery which ranges 0-150 and higher QoR-15 scores indicate better postoperative recovery

Secondary Outcome Measures

Name	Time	Method
Consumption of opioid	during operation	The consumption of opioid reffers to remifentanil consumption
The 15-item QoR score	72 hour and 1 month after surgery	The 15-item QoR score is used to asses quality of recovery after surgery which ranges 0-150 and higher QoR-15 scores indicate better postoperative recovery
The NRS score	before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery	Postoperative pain will be quantified using the NRS ranging from 0 to 10, where 0 means "no pain at all" and 10 means "the worst pain imaginable"
The patients with PONV	24 hour after surgery	postoperative nausea and vomiting

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China