External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

External Oblique Intercostal Plane Block for Postoperative Analgesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Postoperative Pain; Analgesia
• Intervention / Treatment: Other: Intravenous morphine patient control device; Other: External oblique intercostal plane block

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istinye University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia	Other: Intravenous morphine patient control device; 24-hour morphine consumption will be recorded
Active Comparator: 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	Other: Intravenous morphine patient control device; 24-hour morphine consumption will be recorded; Other: External oblique intercostal plane block; External oblique intercostal plane block will be administered before the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative visual analog scale scores	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.	Postoperative 24 hours
Time to first rescue analgesic	The time for administration of first rescue analgesic will be recorded.	postoperative 24 hours
Rescue analgesic drug consumption	The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.	postoperative 24 hours
Incidence of postoperative nausea and vomiting	Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours	postoperative 24 hours

Collaborators and Investigators

• Sponsor: Istinye University
• Investigators: Principal Investigator: Ali Sait Kavakli, M.D., Istinye University; Principal Investigator: Taylan Sahin, M.D., Istinye University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: anestezi1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No