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

Sponsor
Ataturk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05614921
Collaborator
Erzurum City Hospital (Other), Bursa City Hospital (Other)
60
1
2
5
12.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ultrasound guided external oblique intercostal plane block
  • Other: Wound infiltration
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ultrasound Guided External Oblique Intercostal Plane Block vs. Wound Infiltration for Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: External oblique intercostal plane block

Ultrasound-guided External oblique intercostal plane block before surgery

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

Active Comparator: Wound infiltration

Wound infiltration to trocar sites before surgery

Other: Wound infiltration
5 ml local anesthetic for each trocar side

Outcome Measures

Primary Outcome Measures

  1. Postoperative opioid consumption [first 24 hours]

    First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

  1. Visual analog pain score [postextubation 0-24 hours]

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • American Society of Anesthesiologist's physiologic state I-III patients

  • Laparoscopic Obesity surgery

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atatürk University Erzurum Turkey 25100

Sponsors and Collaborators

  • Ataturk University
  • Erzurum City Hospital
  • Bursa City Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali Ahiskalioglu, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT05614921
Other Study ID Numbers:
  • atauniobesity
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 22, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 22, 2022