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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SNB group

control group

Arm Description

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

patients in control group will receive general anesthesia without nerve block.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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"
The patients with PONV
postoperative nausea and vomiting
Consumption of opioid
The consumption of opioid reffers to remifentanil consumption

Full Information

First Posted
April 19, 2022
Last Updated
June 22, 2022
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05353764
Brief Title
Effect of Scalp Nerve Block on the Recovery Quality of Parkinson's Patients After Deep Brain Stimulation
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SNB group
Arm Type
Experimental
Arm Description
patients in the SNB group will receive general anesthesia combined with scalp nerve block and intercostal nerve block with 0.5% ropivacaine.
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients in control group will receive general anesthesia without nerve block.
Intervention Type
Other
Intervention Name(s)
scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
The 15-item QoR score
Description
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
Time Frame
24 hour after surgery
Secondary Outcome Measure Information:
Title
The 15-item QoR score
Description
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
Time Frame
72 hour and 1 month after surgery
Title
The NRS score
Description
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"
Time Frame
before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery
Title
The patients with PONV
Description
postoperative nausea and vomiting
Time Frame
24 hour after surgery
Title
Consumption of opioid
Description
The consumption of opioid reffers to remifentanil consumption
Time Frame
during operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbin Lu
Phone
13004162573
Email
13004162573@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiya Yu, M.D
Phone
13764210333
Email
yuxiyash@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiya Yu, M.D
Organizational Affiliation
Changhai hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Lu
Phone
13004162573
Email
13004162573@163.com
First Name & Middle Initial & Last Name & Degree
Xiya Yu, M.D
Phone
13764210333
Email
yuxiyash@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
36009070
Citation
Sheng Y, Wang H, Chang X, Jin P, Lin S, Qian S, Xie J, Lu W, Yu X. Effect of Scalp Nerve Block Combined with Intercostal Nerve Block on the Quality of Recovery in Patients with Parkinson's Disease after Deep Brain Stimulation: Protocol for a Randomized Controlled Trial. Brain Sci. 2022 Jul 29;12(8):1007. doi: 10.3390/brainsci12081007.
Results Reference
derived

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

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