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

June 22, 2022 updated by: Wen-bin Lu, MD, Changhai Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SNB group
patients in the SNB group will receive general anesthesia combined with scalp nerve block and intercostal nerve block with 0.5% ropivacaine.
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.
NO_INTERVENTION: control group
patients in control group will receive general anesthesia without nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 15-item QoR score
Time Frame: 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
24 hour after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Xiya Yu, M.D, Changhai Hospital, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2022

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (ACTUAL)

April 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNB-QoR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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