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Bilateral External Oblique Intercostal Plane Bock (EOIPB) in Upper Abdominal Surgeries

Not Applicable
Not yet recruiting
Conditions
Post Operative Analgesia
Registration Number
NCT07055438
Lead Sponsor
Kasr El Aini Hospital
Brief Summary

The current study is designed to investigate the analgesic potentials of two modalities of abdominal blocks where local anesthetics is injected in the fascial planes of the abdominal muscles to anesthetize the nerves supplying the abdomen in patients undergoing upper abdomial surgeries.

the two modalities are the rectus sheath block (RSB) and the external oblique intercostal plane block (EOIPB). The investigators are going to use the ultrasound to identify the muscles and inject the local anesthetics. The investigators suggest that the EOIPB might provide better pain control when compared to RSB.

Detailed Description

Fascial plane blocks emerge as an appealing technique to provide good intraoperative and postoperative analgesia in patients undergoing upper abdominal surgeries. Such techniques have the benefit of decreasing opioids use and consequently reducing the like hood of their side effects.

Ultrasound guided rectus sheath Block (RSB) targets the terminal branches of thoracic nerves thus providing analgesia for midline abdominal incisions.

Ultrasound guided external oblique intercostal plane block (EOIPB), a relatively new technique, targets the lateral cutaneous branches of the thoracoabdominal nerves providing analgesia for anterolateral and upper median plane of the abdomen.

Studies Comparing both techniques are deficient, that is why the investigators designed the current study to evaluate and compare the analgesic efficacy of both techniques in upper abdominal surgeries namely Whipple operation and total gastrectomy.

The study is a randomized controlled double blinded trial comprising two groups. The RSB group will receive bilateral ultrasound guided rectus sheath block with 20ml of 0.25% bupivacaine on each side. The EOIB group will receive bilateral ultrasound guided External oblique intercostal plane block with 20ml of 0.25% bupivacaine on each side as well. Both blocks will be performed after administering general anesthesia.

The main endpoint of the study is the time to first request for rescue analgesia.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Age from 18 to 65 Years
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status II, III.
  • Patients who will undergo upper abdominal surgeries (Whipple operation, total gastrectomy).
Exclusion Criteria
  • Coagulation disorders.
  • Abdominal surgery history.
  • Infection in the block application area.
  • Chronic opioid use.
  • Local anesthetic (LA) allergy.
  • Pregnancy.
  • BMI ≥35 kg/m2.
  • Severe cardiovascular problems.
  • Diabetic neuropathy.
  • Complicated surgeries with massive blood loss and hemodynamic instability.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Time to first request for rescue analgesiaTime in hours from end of surgery to first dose of morphine administered up to 24 hours postoperatively

Time from end of surgery to first dose of morphine administered

Secondary Outcome Measures
NameTimeMethod
Fentanyl consumptionFrom the start of the surgery till the end in micogram/Kg

Intraoperative fentanyl consumption

Postoperative morphine consumptionfrom the time numerical rating scale exceeds 3 and till 24 hours after the end of the surgery

Total morphine consumption (mg) in the first 24hrs after surgery

Patient satisfaction of analgesia2 hours after recovery from anesthesia

Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied)

Pain scorefrom the time of recovery immediately in the postoperative period and then at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours postoperatively

Pain score using Numerical rating Scale (NRS)between 0 and 10, Zero means no pain and ten means the worst pain

Incidence of postoperative nausea and vomitingFrom the recovery of anesthesia and up to 24 hours postoperatively

The number of patients suffering from postoperative nausea and vomiting in both groups

Trial Locations

Locations (2)

Kasr El Ainy

🇪🇬

Cairo, Egypt

National Cancer institute

🇪🇬

Cairo, Egypt

Kasr El Ainy
🇪🇬Cairo, Egypt
Rania S Fahmy, Associate Professor
Contact
+201270820372
ransam98@gmail.com

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