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

NCT04752111 | Completed Phase 4

• 1 other identifier: RC3-12-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Esmolol infusion; TAP block; cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual analogue pain score

  every 0,2,4,6,12, up to 24 hours postoperative

• Intraoperative hemodynamic data

  30 minutes after induction of anesthesia

• Postoperative nausea and vomiting

  24 hours postoperative

• Patient satisfaction

  24 hours postoperative

Study Arms (2)

Group E (esmolol infusion)

EXPERIMENTAL

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

Group T (TAP block)

PLACEBO COMPARATOR

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

Interventions

Esmolol DRUG

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

Group E (esmolol infusion); Group T (TAP block)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

esmolol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 12, 2021
• Study Start: January 19, 2021
• Primary Completion: June 15, 2021
• Study Completion: July 20, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-01

Locations

EG (1)