Dose Esmolol Infusion Have an Adjuvant Effect to TAP Block for Pain Control in Laparoscopic Cholecystectomy.

Dose Esmolol Infusion Have an Adjuvant Effect to Transversus Abdominis Plane Block for Pain Control in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Esmolol

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qalubia
    • Benha, Qalubia, Egypt, 13511
      • Samar Rafik Mohamed Amin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ASA grade I/II patients undergoing laparoscopic cholecystectomy .
2. Age group of 18 -60 years.
3. Patients giving valid informed consent.

Exclusion Criteria:

1. Patient refusal
2. Patients belonging to ASA grade III and grade IV .
3. Coagulation disorders.
4. Patients with known allergy to one of the used drugs.
5. Extreme obesity (BMI >35)
6. Patients with cardiac, pulmonary, hepatic or renal disorders
7. Pregnancy
8. Drug abusers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group E (esmolol infusion); 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 .	Drug: Esmolol; administration of a loading dose esmolol infusion 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
PLACEBO_COMPARATOR: Group T (TAP block); 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.	Drug: Esmolol; administration of a loading dose esmolol infusion 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain rescue-analgesia consumption	. 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.	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue pain score	scales from zero (no pain) to ten (unbearable pain)	every 0,2,4,6,12, up to 24 hours postoperative
Intraoperative hemodynamic data	mean arterial blood pressure and heart rate	30 minutes after induction of anesthesia
Postoperative nausea and vomiting	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.	24 hours postoperative
Patient satisfaction	using a 5-point Likert scale (1 was "very unsatisfied", 2- "unsatisfied", 3- "unsure", 4- "satisfied", and 5- "very satisfied").	24 hours postoperative

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 19, 2021
• Primary Completion (ACTUAL): June 15, 2021
• Study Completion (ACTUAL): July 20, 2021

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (ACTUAL): February 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: cholecystectomy; TAP block; Esmolol infusion
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-1 Receptor Antagonists; Esmolol
• Other Study ID Numbers: RC3-12-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No