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

Postoperative Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752111
• Other study ID #: RC3-12-2020
• Status: Completed
• Phase: Phase 4
• Start date: January 19, 2021
• Est. completion date: July 20, 2021

Study information

• Verified date: January 2021
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Samar Rafik Mohamed Amin	Benha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual analogue pain score	scales from zero (no pain) to ten (unbearable pain)	every 0,2,4,6,12, up to 24 hours postoperative
Secondary	Intraoperative hemodynamic data	mean arterial blood pressure and heart rate	30 minutes after induction of anesthesia
Secondary	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
Secondary	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