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

Sponsor

Benha University (Other)

Overall Status

Completed

CT.gov ID

NCT04752111

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Esmolol	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 19, 2021

Actual Primary Completion Date :

Jun 15, 2021

Actual Study Completion Date :

Jul 20, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Visual analogue pain score [every 0,2,4,6,12, up to 24 hours postoperative]
scales from zero (no pain) to ten (unbearable pain)
Intraoperative hemodynamic data [30 minutes after induction of anesthesia]
mean arterial blood pressure and heart rate
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").

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samar Rafik Mohamed Amin	Benha	Qalubia	Egypt	13511

Sponsors and Collaborators

Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samar Rafik Mohamed Amin, lecturer of anesthesia and surgical ICU, Benha University

ClinicalTrials.gov Identifier:

NCT04752111

Other Study ID Numbers:

RC3-12-2020

First Posted:

Feb 12, 2021

Last Update Posted:

Oct 1, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Samar Rafik Mohamed Amin, lecturer of anesthesia and surgical ICU, Benha University

Esmolol infusion

TAP block

cholecystectomy

Additional relevant MeSH terms:

Pain, Postoperative

Esmolol

Study Results

No Results Posted as of Oct 1, 2021