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OpenTrials
Completed

NCT Number: NCT04752111

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. pain rescue-analgesia consumption

    Time frame: 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 outcomes

  1. Visual analogue pain score

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

    scales from zero (no pain) to ten (unbearable pain)

  2. Intraoperative hemodynamic data

    Time frame: 30 minutes after induction of anesthesia

    mean arterial blood pressure and heart rate

  3. Postoperative nausea and vomiting

    Time frame: 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.

  4. Patient satisfaction

    Time frame: 24 hours postoperative

    using a 5-point Likert scale (1 was "very unsatisfied", 2- "unsatisfied", 3- "unsure", 4- "satisfied", and 5- "very satisfied").

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2021
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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