Pain Management in Laparoscopic Cholecystectomies

NCT ID: NCT05837702

Last Updated: 2023-05-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-01-10

Brief Summary

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Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.

Detailed Description

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The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.

Conditions

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Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Erector Spinae Plane Block (ESPB)

The spinous processes of the vertebrae were marked up to T8 level. After providing antisepsis of the skin with 10% povidone iodine, the ultrasound probe was placed at T8 level parallel to the vertebral spine at T8. The transverse process (TP) and hyperechoic pleura were observed 2.5cm right lateral of the spinous process. Using the in-plane approach, the needle was placed in the caudal direction. After confirming displacement of the pleura with 0.5-1ml local anaesthetic (LA), 20ml 0.25% bupivacaine was administered for the block .

Group Type EXPERIMENTAL

ESPB

Intervention Type PROCEDURE

Erector spinae plane block

Paravertebral Block (PVB)

After sterilisation of the skin with povidone iodine, the probe covered with a sterile sheath was placed 3cm lateral of the T8 spinous process. The trapezius, rhomboid major, and erector spinae muscles, and the TP of the vertebrae were visualised. The needle was placed craniocaudally within the fascial plane of the deep surface of the erector spina muscle above the bone shadow of the TP. The fluid dissemination was confirmed by raising the placement of the needle tip towards the erector spina muscle. 20ml 0.25% bupivacaine was applied to this region and the spread of local anaesthetic was observed

Group Type ACTIVE_COMPARATOR

PVB

Intervention Type PROCEDURE

Paravertebral Block

Control

No block has been done

Group Type ACTIVE_COMPARATOR

CONTROL

Intervention Type PROCEDURE

No block has been done

Interventions

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ESPB

Erector spinae plane block

Intervention Type PROCEDURE

PVB

Paravertebral Block

Intervention Type PROCEDURE

CONTROL

No block has been done

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* aged \>18 years
* patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery

Exclusion Criteria

* Did not provide informed consent,
* Had any psychiatric or mental problem that prevented understanding of the informed consent form
* They were planned to undergo emergency cholecystectomy,
* Had any allergy or hypersensitivity to local anaesthetic,
* Had an infection in the needle entry area
* History of coagulopathy or the use of anticoagulants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Elvan Yilmaz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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elvan tekir yilmaz

Role: STUDY_DIRECTOR

Giresun University

Locations

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Giresun University Medical School Hospital.

Giresun, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2021/ 283

Identifier Type: -

Identifier Source: org_study_id

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