Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06656299

Evaluation of Post-Operative Pain Relief Using External Oblique Intercostal Plane Block Versus Trocar Site Infiltration in Patients Undergoing Laparoscopic Gallbladder Removal

Led by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Updated on 2024-11-01

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of the External Oblique Intercostal Plane Block (EOIB) compared to trocar entry site infiltration for managing pain after laparoscopic cholecystectomy, a common surgery to remove the gallbladder. This study aims to reduce postoperative pain, opioid use, and related side effects while improving patient comfort and recovery. The trial addresses the challenges caused by surgical trauma and the importance of managing pain to avoid complications and shorten hospital stays. Participants will undergo laparoscopic cholecystectomy under general anesthesia and be randomly assigned to one of two groups. One group receives the EOIB, where a local anesthetic is injected between the external oblique muscle and the 6th rib under ultrasound guidance on both sides of the body. The other group receives infiltration of local anesthetic directly at the trocar entry sites after surgery. All patients receive standard multimodal analgesia with intravenous paracetamol, tramadol, and ondansetron before surgery ends, and morphine via patient-controlled analgesia postoperatively. During the 24 hours after surgery, participants will be monitored for pain levels using a numeric rating scale, opioid consumption, time to first additional pain medication, and any adverse events. Researchers will also assess recovery quality using a questionnaire. The study includes detailed monitoring of medications and side effects, with follow-up lasting the first day after surgery to evaluate pain control and recovery outcomes.

CONDITIONS

Brief Title

EOIB for Laparoscopic Cholecystectomy

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 65 scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • ASA physical status I, II, or III
Not Eligible

You will not qualify if you...

  • Presence of blood clotting disorders
  • Infection at the injection site for the block
  • Known allergy to local anesthetics
  • Advanced liver, heart, or kidney failure
  • History of abdominal surgery or trauma
  • Conversion from laparoscopic to open surgery
  • Use of painkillers within 24 hours before surgery
  • Chronic opioid use
  • Pregnancy
  • Alcohol or drug abuse
  • Body mass index of 35 kg/m2 or higher
  • Cognitive impairment such as Alzheimer's or dementia
  • Emergency cholecystectomy cases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo laparoscopic gallbladder removal surgery under general anesthesia.

1 visit (in-person)

Treatment

Duration - Up to 24 hours post-surgery

Participants receive either an ultrasound guided external oblique intercostal plane block or trocar site infiltration with local anesthetic during surgery, along with standard multimodal analgesia including paracetamol, tramadol, and ondansetron administered before the end of surgery and postoperative pain management.

1 postoperative recovery visit and continuous monitoring for 24 hours

Post-operative Follow-up

Duration - 24 hours post-surgery

Participants are monitored for pain levels, opioid consumption, adverse events, and recovery quality within the first 24 hours after surgery.

Approximately 1 follow-up visit within 24 hours

Trial Site Locations

Total: 1 location

1

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial.

Muhammet Korkusuz, Betul Basaran, Tayfun Et...

https://pubmed.ncbi.nlm.nih.gov/37777270

External Oblique Intercostal Plane Block Versus Port-Site Infiltration for Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study.

Omer Doymus, Ali Ahiskalioglu, Ahmet Kaciroglu...

https://pubmed.ncbi.nlm.nih.gov/38565828

Efficacy of Unilateral External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block in Laparoscopic Cholecystectomy: Randomized, Prospective Study.

Çömez Mehmet Selim, Sağlambilen Halide, Çelik Erkan Cem...

https://pubmed.ncbi.nlm.nih.gov/38780355