NCT05353764

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

April 19, 2022

Last Update Submit

June 22, 2022

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The 15-item QoR score

    72 hour and 1 month after surgery

  • The NRS score

    before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery

  • The patients with PONV

    24 hour after surgery

  • Consumption of opioid

    during operation

Study Arms (2)

SNB group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

scalp nerve block combined with intercostal nerve block using 0.5% ropivacaineOTHER

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.

SNB group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36009070DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Xiya Yu, M.D

    Changhai hospital, Shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenbin Lu

CONTACT

1300416257313004162573@163.com

Xiya Yu, M.D

CONTACT

13764210333yuxiyash@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 29, 2022

Study Start

April 20, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations

CN(1)