Dexmetomidine With Erector Spinae Plane Block in Cholecystectomy

NCT ID: NCT05369468

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2022-11-10

Brief Summary

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 .

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.

Conditions

Dexmedtomidine in Erector Spinae Block for Laparscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

group 1

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

Group Type: PLACEBO_COMPARATOR

Bupivacain only

Intervention Type: DRUG

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.

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 .

Group Type: EXPERIMENTAL

dexmedetomidine as adjuvant with bupivacaine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Wafaa Madhy Atia Abdelwahed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, , Egypt

Countries

Egypt

Other Identifiers

35225/1/22

Identifier Type: -

Identifier Source: org_study_id