External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

NCT05663658 | Completed

• 1 other identifier: anestezi1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Analgesia; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative visual analog scale scores

  Postoperative 24 hours

• Time to first rescue analgesic

  postoperative 24 hours

• Rescue analgesic drug consumption

  postoperative 24 hours

• Incidence of postoperative nausea and vomiting

  postoperative 24 hours

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Intravenous morphine patient control device

External oblique intercostal plane block group

ACTIVE COMPARATOR

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; Other: External oblique intercostal plane block

Interventions

Intravenous morphine patient control device OTHER

24-hour morphine consumption will be recorded

Control group; External oblique intercostal plane block group

External oblique intercostal plane block OTHER

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

External oblique intercostal plane block group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38499943 DERIVED

MeSH Terms

Conditions

Obesity; Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Ali Sait Kavakli, M.D.

  Istinye University

  PRINCIPAL INVESTIGATOR

• Taylan Sahin, M.D.

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: December 23, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 15, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-01

Locations

TU (1)