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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Esmolol
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Esmolol infusion, TAP block, cholecystectomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Samar Rafik Mohamed Amin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group E (esmolol infusion)

Group T (TAP block)

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual analogue pain score
scales from zero (no pain) to ten (unbearable pain)
Intraoperative hemodynamic data
mean arterial blood pressure and heart rate
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.
Patient satisfaction
using a 5-point Likert scale (1 was "very unsatisfied", 2- "unsatisfied", 3- "unsure", 4- "satisfied", and 5- "very satisfied").

Full Information

First Posted
January 28, 2021
Last Updated
September 26, 2021
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT04752111
Brief Title
Dose Esmolol Infusion Have an Adjuvant Effect to TAP Block for Pain Control in Laparoscopic Cholecystectomy.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Esmolol infusion, TAP block, cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blinded
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group E (esmolol infusion)
Arm Type
Experimental
Arm Description
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 .
Arm Title
Group T (TAP block)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Esmolol
Intervention Description
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 Outcome Measure Information:
Title
pain rescue-analgesia consumption
Description
. 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.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Visual analogue pain score
Description
scales from zero (no pain) to ten (unbearable pain)
Time Frame
every 0,2,4,6,12, up to 24 hours postoperative
Title
Intraoperative hemodynamic data
Description
mean arterial blood pressure and heart rate
Time Frame
30 minutes after induction of anesthesia
Title
Postoperative nausea and vomiting
Description
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.
Time Frame
24 hours postoperative
Title
Patient satisfaction
Description
using a 5-point Likert scale (1 was "very unsatisfied", 2- "unsatisfied", 3- "unsure", 4- "satisfied", and 5- "very satisfied").
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samar Rafik Mohamed Amin
City
Benha
State/Province
Qalubia
ZIP/Postal Code
13511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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