External Oblique Intercostal Plane Block vs. Wound Infiltration for Laparoscopic Sleeve Gastrectomy

NCT05614921 | Completed

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

Brief Summary

The morbidity and mortality associated with being overweight or obese have been known to the medical profession since Hippocrates, more than 2500 years ago. Pain that develops following bariatric surgery may prolong recovery time. Most morbidly obese patients have obstructive sleep apnea and cardiac comorbidities. In these patients, prolonged postoperative pain may cause early ambulation and delay performing deep breathing exercises. Using regional anesthetic techniques results in less opioid use and better pain management. External oblique internal costal block; It is a new block that provides dermatomal sensory blockage involving T6-T10 in the anterior axillary line and T6-T9 in the midline. It can be used as part of multimodal analgesia in laparoscopic cases. There is no study in the literature regarding the use of external oblique plane block in bariatric surgery yet.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  First 24 hours total fentanyl consumption with patient controlled analgesia

  first 24 hours

Secondary Outcomes (1)

• Visual analog pain score

  postextubation 0-24 hours

Study Arms (2)

External oblique intercostal plane block

ACTIVE COMPARATOR

Ultrasound-guided External oblique intercostal plane block before surgery

Other: ultrasound guided external oblique intercostal plane block

Wound infiltration

ACTIVE COMPARATOR

Wound infiltration to trocar sites before surgery

Other: Wound infiltration

Interventions

ultrasound guided external oblique intercostal plane block OTHER

ultrasound guided external oblique intercostal plane block 30 ml local anesthetic each side

External oblique intercostal plane block

Wound infiltration OTHER

5 ml local anesthetic for each trocar side

Wound infiltration

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologist's physiologic state I-III patients
• Laparoscopic Obesity surgery

You may not qualify if:

• Chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Sponsors & Collaborators

• Ataturk University: lead
• Erzurum City Hospital: collaborator
• Bursa City Hospital: collaborator

Study Sites (1)

Atatürk University

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (2)

• White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.

  PMID: 35249704 BACKGROUND

• Cosarcan SK, Yavuz Y, Dogan AT, Ercelen O. Can Postoperative Pain Be Prevented in Bariatric Surgery? Efficacy and Usability of Fascial Plane Blocks: a Retrospective Clinical Study. Obes Surg. 2022 Sep;32(9):2921-2929. doi: 10.1007/s11695-022-06184-9. Epub 2022 Jul 1.

  PMID: 35776242 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: November 15, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 15, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

TU (1)