External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

NCT ID: NCT05663658

Last Updated: 2023-05-26

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-23

Study Completion Date

2023-05-15

Brief Summary

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The external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the anterior axillary line and T6-T9 at the midline. It may be used for postoperative analgesia in obese patients because it is superficial and rapidly identifiable and performed in the supine position. the aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block in obese patients undergoing laparoscopic sleeve gastrectomy.

Researchers will compare the external oblique intercostal plane block group with control group to see if the EOI plane block is effective for postoperative analgesia in patients undergoing sleeve gastrectomy.

Detailed Description

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Patients scheduled for elective laparoscopic sleeve gastrectomy will be separated into 2 groups: Control Group and External Oblique Intercostal Plane Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block before the surgery and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

Conditions

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Obesity Analgesia Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia

Group Type ACTIVE_COMPARATOR

Intravenous morphine patient control device

Intervention Type OTHER

24-hour morphine consumption will be recorded

External oblique intercostal plane block group

The patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia

Group Type ACTIVE_COMPARATOR

Intravenous morphine patient control device

Intervention Type OTHER

24-hour morphine consumption will be recorded

External oblique intercostal plane block

Intervention Type OTHER

External oblique intercostal plane block will be administered before the surgery.

Interventions

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Intravenous morphine patient control device

24-hour morphine consumption will be recorded

Intervention Type OTHER

External oblique intercostal plane block

External oblique intercostal plane block will be administered before the surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 80 years
* Patients with American Society of Anesthesiology (ASA) physical status II-III
* Patients scheduled for a laparoscopic sleeve gastrectomy

Exclusion Criteria

* Allergy to local anesthetics
* Coagulopathy
* Skin infection at the EOI Plane Block area
* Advanced hepatic or renal failure
* Chronic pain syndromes
* Alcohol or drug abuse
* Severe pulmonary and/or cardiovascular disease
* Psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Sait Kavakli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istinye University

Taylan Sahin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istinye University

Locations

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Istinye University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kavakli AS, Sahin T, Koc U, Karaveli A. Ultrasound-Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective, Randomized, Controlled, Patient and Observer-Blinded Study. Obes Surg. 2024 May;34(5):1505-1512. doi: 10.1007/s11695-024-07174-9. Epub 2024 Mar 18.

Reference Type DERIVED
PMID: 38499943 (View on PubMed)

Other Identifiers

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anestezi1

Identifier Type: -

Identifier Source: org_study_id

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