Dose Esmolol Infusion Have an Adjuvant Effect to TAP Block for Pain Control in Laparoscopic Cholecystectomy.
- Registration Number
- NCT04752111
- Lead Sponsor
- Benha University
- Brief Summary
Pain after laparoscopy differs considerably from that seen after laparotomy. Laparotomy results mainly in parietal pain (abdominal wall), where as Pain in laparoscopy results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity. The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). While esmolol is an ultra-short acting intravenous β-blocker having a rapid onset and offset effect. It provides an unprecedented level of tolerability and safety in the perioperative setting. When used as an adjunct, it has been shown to improve the postoperative recovery by reducing postoperative pain intensity and intraoperative anesthetic and opioid requirements and preventing opioid-induced hyperalgesia . The mechanism of this synergistic effect is uncertain, but both pharmacokinetic and pharmacodynamics interactions with anesthetic drugs have been proposed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- ASA grade I/II patients undergoing laparoscopic cholecystectomy .
- Age group of 18 -60 years.
- Patients giving valid informed consent.
- Patient refusal
- Patients belonging to ASA grade III and grade IV .
- Coagulation disorders.
- Patients with known allergy to one of the used drugs.
- Extreme obesity (BMI >35)
- Patients with cardiac, pulmonary, hepatic or renal disorders
- Pregnancy
- Drug abusers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group E (esmolol infusion) Esmolol 10 minutes before induction of anesthesia the patients will receive a loading dose of injection esmolol 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side . Group T (TAP block) Esmolol 10 minutes before induction of anesthesia the patients will receive a loading dose of injection 30 ml isotonic saline in the iv line, followed by an IV infusion of saline at a rate of 0.05 mg/kg/min till the completion of surgery After induction of anesthesia and before starting the surgery, patients will receive bilateral in-plane ultrasound guided transversus abdominis plane block with 40 ml of bupivacaine 0. 25% after induction of anesthesia 20 ml in each side.
- Primary Outcome Measures
Name Time Method pain rescue-analgesia consumption 24 hours postoperative . If pain score exceed 3, rescue analgesia 5 mg bolus of morphine will be administered intravenous to achieve satisfactory pain control that can be repeated every 4-6 hours.
- Secondary Outcome Measures
Name Time Method Postoperative nausea and vomiting 24 hours postoperative A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting. Ondansetron 4 mg will be available if required.
Patient satisfaction 24 hours postoperative using a 5-point Likert scale (1 was "very unsatisfied", 2- "unsatisfied", 3- "unsure", 4- "satisfied", and 5- "very satisfied").
Intraoperative hemodynamic data 30 minutes after induction of anesthesia mean arterial blood pressure and heart rate
Visual analogue pain score every 0,2,4,6,12, up to 24 hours postoperative scales from zero (no pain) to ten (unbearable pain)
Trial Locations
- Locations (1)
Samar Rafik Mohamed Amin
🇪🇬Benha, Qalubia, Egypt