External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Obesity; Analgesia; Postoperative Pain
• Interventions: Other: Intravenous morphine patient control device; Other: External oblique intercostal plane block

• Registration Number: NCT05663658
• Lead Sponsor: Istinye University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-15
• Study Start: 2022-12-23
• Study First Posted: 2022-12-23
• Status Verified: 2023-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-15
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External oblique intercostal plane block group	Intravenous morphine patient control device	The patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia
Control group	Intravenous morphine patient control device	The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia
External oblique intercostal plane block group	External oblique intercostal plane block	The patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia

Primary Outcome Measures

Name	Time	Method
Morphine consumption	Postoperative 24 hours	The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.

Secondary Outcome Measures

Name	Time	Method
Postoperative visual analog scale scores	Postoperative 24 hours	Postoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.
Rescue analgesic drug consumption	postoperative 24 hours	The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
Time to first rescue analgesic	postoperative 24 hours	The time for administration of first rescue analgesic will be recorded.
Incidence of postoperative nausea and vomiting	postoperative 24 hours	Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours

Trial Locations

Locations (1)

Istinye University Hospital; 🇹🇷 Istanbul, Turkey