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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04752111

Enrollment

Registered

2021-02-12

Start date

2021-01-19

Completion date

2021-07-20

Last updated

2021-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Esmolol infusion, TAP block, cholecystectomy

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.

Interventions

DRUGEsmolol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

double blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026