NCT05632991

Brief Summary

The laparoscopic approach has become the gold standard for many abdominal surgical procedures, including cholecystectomy. Compared to laparotomy, laparoscopy allows smaller incisions, reduces perioperative stress response, reduces postoperative pain, and results in shorter recovery time. However, anaesthesia concerns in patients undergoing laparoscopic surgery are different from patients undergoing open abdominal surgery. The aim of this study is to investigate the effect of the external oblique intercostal block, which is a new block, on postoperative pain score and opioid consumption.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

November 21, 2022

Last Update Submit

March 29, 2024

Conditions

Analgesia

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

Subcostal Transversus Abdominis Plan Block Group

ACTIVE COMPARATOR

Ultrasound-guided Subcostal Transversus Abdominis Plan Block Group

Other: Subcostal Transversus Abdominis Plan Block Group

Interventions

ultrasound guided external oblique intercostal plane blockOTHER

ultrasound guided external oblique intercostal plane block 20 ml local anesthetic each side

External oblique intercostal plane block
Subcostal Transversus Abdominis Plan Block GroupOTHER

ultrasound guided Subcostal Transversus Abdominis Plan Block Group 20 ml local anesthetic each side

Subcostal Transversus Abdominis Plan Block Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (3)

  • Woldu SL, Weinberg AC, Bergman A, Shapiro EY, Korets R, Motamedinia P, Badani KK. Pain and analgesic use after robot-assisted radical prostatectomy. J Endourol. 2014 May;28(5):544-8. doi: 10.1089/end.2013.0783. Epub 2014 Jan 30.

    PMID: 24400824BACKGROUND

  • Leitao MM Jr, Malhotra V, Briscoe G, Suidan R, Dholakiya P, Santos K, Jewell EL, Brown CL, Sonoda Y, Abu-Rustum NR, Barakat RR, Gardner GJ. Postoperative pain medication requirements in patients undergoing computer-assisted ("Robotic") and standard laparoscopic procedures for newly diagnosed endometrial cancer. Ann Surg Oncol. 2013 Oct;20(11):3561-7. doi: 10.1245/s10434-013-3064-9.

    PMID: 23797751BACKGROUND

  • Al S, Ahiskalioglu A, Karapinar YE, Yayik AM, Aydin ME, Celik EC, Ahiskalioglu EO, Doymus O. External oblique intercostal plane block as an alternative to subcostal TAP block for laparoscopic cholecystectomy: a prospective randomized study. BMC Anesthesiol. 2025 Dec 5;26(1):26. doi: 10.1186/s12871-025-03548-3.

    PMID: 41351140DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological 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 21, 2022

First Posted

December 1, 2022

Study Start

December 1, 2022

Primary Completion

September 1, 2023

Study Completion

January 1, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Locations

TU(1)