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

NCT ID: NCT05353764

Last Updated: 2022-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-03-01

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SNB group

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-bin Lu, MD

Attending doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiya Yu, M.D

Role: PRINCIPAL_INVESTIGATOR

Changhai hospital, Shanghai, China

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenbin Lu

Role: CONTACT

13004162573

Xiya Yu, M.D

Role: CONTACT

13764210333

Facility Contacts

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Wenbin Lu

Role: primary

13004162573

Xiya Yu, M.D

Role: backup

13764210333

References

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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.

Reference Type DERIVED
PMID: 36009070 (View on PubMed)

Other Identifiers

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SNB-QoR

Identifier Type: -

Identifier Source: org_study_id

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