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

Parkinson Disease Clinical Trial

Official title:

Effect of Scalp Nerve Block Combined With Intercostal Nerve Block on Quality of Recovery After Deep Brain Stimulation in Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353764
• Other study ID #: SNB-QoR
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2022
• Source: Changhai Hospital
• Contact: Wenbin Lu
• Phone: 13004162573
• Email: 13004162573[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine
Participants randomized to the SNB group will receive general anesthesia combined with scalp nerve block and intercostal nerve block with 0.5% ropivacaine, which was performed exclusively by an attending anesthesiologist.An attending anesthesiologist will select the site of SNB based on the surgical incision site. Scalp nerve was blocked including greater occipital nerve (2-3ml), superficial temporal nerve (2-3ml), trochlear nerve (2-3ml) and supraorbital nerve (2-3ml). The total volume in scalp nerve block will not exceed 10 ml.Ultrasound-guided unilateral ICNB will be performed at the level of T4-T5 next to the sternum.10-15ml of 0.5% ropivacaine will be injected into the intercostal spaces where incision locates after negative aspiration.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 15-item QoR score	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	24 hour after surgery
Secondary	The 15-item QoR score	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	72 hour and 1 month after surgery
Secondary	The NRS score	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"	before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery
Secondary	The patients with PONV	postoperative nausea and vomiting	24 hour after surgery
Secondary	Consumption of opioid	The consumption of opioid reffers to remifentanil consumption	during operation