Dexmetomidine With Erector Spinae Plane Block in Cholecystectomy

Efficacy of Adding Dexmedetomidine to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Prospective Randomized Trial

Sixty patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned using sealed envelope into two equal groups (30 patients each).

Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .

Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .

Study Overview

• Status: Completed
• Conditions: Dexmedtomidine in Erector Spinae Block for Laparscopic Cholecystectomy
• Intervention / Treatment: Drug: Bupivacain only; Drug: dexmedetomidine as adjuvant with bupivacaine

Detailed Description

This prospective randomized study will be carried out in general surgery Department within 6 months from January 2022 to June 2022 on the 60 patients scheduled for elective laparoscopic cholecystectomy . A written informed consent will be obtained from the patients. Every patient will receive an explanation to the purpose of the study and will have a secret code number and the photos applied only to the part of the body linked to the research to ensure privacy to participants and confidentiality of data.

Research results will be only used for scientific purposes. Procedures will be approved by both the Institutional and the Regional ethical committees.

The risk that may occur is minimal, inadequate analgesia and this risk will be overcome by tramadol 50 mg intravenously STAT dose. Any unexpected risk appears during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks.

The research end point when reach desired lower pain score postoperative without occurance of any complication as heamodynamic instability.

. Preanesthetic checkup and routine investigations, such as complete blood count test, liver &kidney function test and coagulation profile, will be done. Patients will be kept fasting for 8 h.

On arrival in the operative room, standard monitoring equipment will be attached (electrocardiogram, pulse oximeter, and noninvasive blood pressure) and baseline vital parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), and oxygen saturation (SpO2) will be noted just before induction of anesthesia. Peripheral venous access will be obtained IV crystalloid at rate 10 ml\kg will be infused.

Technique of ultrasound guided Erector spine plane block:

The pa¬tient will be placed in sitting position and the ultrasound-guided ESP block was performed bilaterally at the (T7) level. A 23 G spinal needle was inserted with the bevel in cephalo- caudal direction .

Sixty patients will be randomly assigned using sealed envelope into two equal groups (30 patients each).

Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .

Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .

Anesthesia will be induced with injection of propofol 2 mg/kg, and fentanyl 1ug/kg intravenous (I.V) Endotracheal intubation will be facilitated with injection rocuronium bromide 0.9 mg/kg IV. Anesthesia will be maintained with in O2 with sevoflurane 2% to maintained BIS 40-60. Neuromuscular relaxation will be maintained with injection rocuronium top ups of 0.3 mg i.v every hour.

The lungs will be mechanically ventilated to keep end-tidalCO2 within normal range and residual neuromuscular block will be reversed with injection neostigmine (0.05 mg/kg) and injection atropine (0.01 mg/kg). The patients will be extubated when respiration deemed sufficient. The patients will be transferred to recovery room. In the post anesthesia care unit(PACU), they will be monitored for any evidence of complications or adverse events and discharged when aldert score ≥ 9.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: wafaa abdelwahed, phd; Phone Number: 00201011242278; Email: wafaa.abdelwahed@med.tanta.edu.eg
• Study Contact Backup: Name: elsayed negm, phd; Phone Number: 00201030791838; Email: elsayed.negm@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt, 31511
    • Tanta University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

• Patients undergoing elective laparoscopic cholecystectomy
• aged 18-65 years old
• ASA physical status I or II.

Exclusion Criteria:

• patients who refuse to give written informed consent

  • sever respiratory or cardiac disorder
  • coagulopathy
  • local infection at injection site
  • spine or chest wall deformity
  • patients with known allergy to the drugs used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group 1; Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .	Drug: Bupivacain only; to assess efficacy of bupivacain alone in ultrasound-guided erector spinae plane block in patient undergoing laporoscopic cholecystectomy. primary outcome was the total amount of morphine consumption in the first 24-hour postoperative, and the secondary outcomes were the time of first rescue analgesia ,pain score, and safety.
Experimental: group 2; Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .	Drug: dexmedetomidine as adjuvant with bupivacaine; to assess efficacy of adding dexmedetomidine as adjuvant with bupivacaine in ultrasound-guided erector spinae plane block in patient undergoing laporoscopic cholecystectomy. primary outcome was the total amount of morphine consumption in the first 24-hour postoperative, and the secondary outcomes were the time of first rescue analgesia ,pain score, and safety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative morphine consumption	the total amount of morphine consumption in the first 24-hour postoperative	first 24 hours

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: dexmedtomidine-erector spinae block-cholecystectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: 35225/1/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the result will be shared only after completion of the study and publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No