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/37777270Actively Recruiting
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
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
EOIB for Laparoscopic Cholecystectomy
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo laparoscopic gallbladder removal surgery under general anesthesia.
1 visit (in-person)
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
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
Total: 1 location
1
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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