Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy.

NCT05536557 | Completed

• 1 other identifier: 02-2022/11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will define the postoperative analgesic effect of ultrasound-guided bilateral External Oblique İntercostal (EOI) Plane Block and compare the control group in patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative opioid consumption of EOI plane block versus control group. It is hypothesized that postoperative opioid use will be less in patients with EOI plane block than in patients who only receive routine multimodal analgesia.

Conditions

Laparoscopic Cholecystectomy

Keywords

Laparoscopic Cholecystectomy; Acute Postoperative Pain; Nerve block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.

  Postoperative 24 hours

Secondary Outcomes (6)

• Numerical Rating Scale scores

  Postoperative 24 hours

• Time to first rescue analgesic

  Postoperative 24 hours

• Adverse events

  Postoperative 24 hours

• Metoclopromide consumption

  Postoperative 24 hours

• Sedation score

  Postoperative 24 hour

Study Arms (2)

Group (EOI) Plane Block

ACTIVE COMPARATOR

After tracheal intubation, a high-frequency linear probe will be in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle identified at the level ribs 6 and 7 in line. A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to EOI plane. The same procedure will be repeated on the contralateral side. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.

Other: Bilateral External Oblique İntercostal (EOI) Plane Block

Group N

SHAM COMPARATOR

The patients in Group N will not receive any intervention. In the intervention and control groups, block sites will be covered with dressings, and patients and other health care workers will be blinded to treatment allocation. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.

Other: Standard perioperative and postoperative multimodal analgesia

Interventions

Bilateral External Oblique İntercostal (EOI) Plane Block OTHER

External Oblique İntercostal (EOI) Plane Block will be provided for postoperative pain for Laparoscopic Cholecystectomy with Bupivacaine. And patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.

Also known as: Quality of Recovery-15 score, Standard Pain Followup and Monitorization

Group (EOI) Plane Block

Standard perioperative and postoperative multimodal analgesia OTHER

Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol for Laparoscopic Cholecystectomy.

Also known as: Quality of Recovery-15 score, Standard Pain Followup and Monitorization

Group N

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study.

You may not qualify if:

• presence of coagulation disorder
• infection at the injection site of the block
• known allergy to local anesthetics
• advanced hepatic or renal failure
• can not communicate in Turkish
• history of abdominal surgery or trauma
• conversion of laparoscopic to open surgery
• consumption of any pain killers within the 24 h before the operation
• chronic opioid consumption
• pregnancy
• alcohol or drug abuse
• body mass index (BMI) ≥ 35 kg m-2.

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Related Publications (1)

• Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Yildirim H. Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Saudi Med J. 2023 Oct;44(10):1037-1046. doi: 10.15537/smj.2023.44.10.20230350.

  PMID: 37777270 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Muhammet Korkusuz, MD

  Karaman Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple (Participant, Care Provider, Investigator) Blocks will be administered after induction of general Anesthesia so participants will be blinded to which intervention they have had.Study investigators will not be aware of what group the participant belongs to when assessing the patient at post-operative period
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: There are two group; 1. Experimental Group: Group (EOI) Plane Block ; A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to EOI plane. The same procedure will be repeated on the contralateral side. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol. 2. Sham Comparator Group:The patients will not receive any intervention. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 13, 2022
• Study Start: September 15, 2022
• Primary Completion: November 23, 2022
• Study Completion: November 24, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)