Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery

NCT ID: NCT05984212

Last Updated: 2023-08-09

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-07-31

Brief Summary

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In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block.

Detailed Description

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Conditions

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Single Port Laparoscopic Adnexal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation

Study Groups

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dexmedetomidine infusion group

Group Type EXPERIMENTAL

Ultrasound guided rectus sheath block with dexmedetomidine

Intervention Type DRUG

Intervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral)

normal saline infusion group

Group Type PLACEBO_COMPARATOR

Ultrasound guided rectus sheath block with normal saline

Intervention Type DRUG

Control Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral)

Interventions

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Ultrasound guided rectus sheath block with dexmedetomidine

Intervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral)

Intervention Type DRUG

Ultrasound guided rectus sheath block with normal saline

Control Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Adult female patient aged 19 years or older undergoing elective single-port laparoscopic adnexal surgery under general anesthesia at Yonsei Cancer Center

1\. patients with moderate to severe pain before surgery 2. patients with history of taking chronic analgesic use, 3. patients allergic or hypersensite to remifentanil or local anesthetic (ropivacaine), 4. patients with infection at the site of the block, 5. patietns who cannot communicate
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Youngwon Kim

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Youngwon Kim

Role: CONTACT

82-10-4240-6849

Facility Contacts

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Youngwon Kim

Role: primary

82-10-4240-6849

Other Identifiers

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4-2023-0611

Identifier Type: -

Identifier Source: org_study_id

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