Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block

NCT06386770 | Recruiting Phase 3

• 1 other identifier: Asw.U./742 /2/23
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries.

Conditions

Erector Spinae Block; Dexmedetomidine

Keywords

Bupivacaine; kidney exploration surgery

Outcome Measures

Primary Outcomes (1)

• The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics.

  The duration of analgesia, this was defined as the time in minutes to the first request for

  at 60 , 180 minutes

Secondary Outcomes (4)

• 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period .

  at 1, 3, 6, 12, 24, 36 and 48 hours

• Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed

  at 1, 3, 6, 12, 24, 36 and 48 hours

• Intraoperative hemodynamic parameters blood pressure

  at 1, 3, 6, hours

• Minimum alveolar concentration (MAC) requirements

  during intraoperative periods expressed in minutes

Study Arms (3)

Group Ι Block only (group BO) (control group)

ACTIVE COMPARATOR

Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Drug: Bupivacaine Hydrochloride

Group ΙI (group DL):

ACTIVE COMPARATOR

Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexmedetomidine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9%) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Drug: Dexmedetomidine Injection [Precedex]

Group III (group D IV):

ACTIVE COMPARATOR

Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexmedetomidine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia

Drug: Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)

Interventions

Dexmedetomidine Injection [Precedex] DRUG

Group ΙI (group DL): erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexamedetomedine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9% ) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Group ΙI (group DL):

Bupivacaine Hydrochloride DRUG

.Group Ι Block only (group BO) (control group): erector spinae block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Group Ι Block only (group BO) (control group)

Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) DRUG

Group III (group D IV): erector spinea block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexamedetomedine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia.

Group III (group D IV):

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• . kidney exploration surgeries.
• ASA I/II patients.
• BMI \<35

You may not qualify if:

• Getting opioid analgesics prior to surgery.
• Local infections at the site where needle for block is to be inserted.
• ASAIII/IV.
• Pregnancy.
• History of drug addiction or alcohol abuse or a psychiatric illness,

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University

Aswān, Aswan Governorate, 81511, Egypt

RECRUITING

Related Publications (2)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Wang Q, Li H, Wei S, Zhang G, Ni C, Sun L, Zheng H. Dexmedetomidine Added to Ropivacaine for Ultrasound-guided Erector Spinae Plane Block Prolongs Analgesia Duration and Reduces Perioperative Opioid Consumption After Thoracotomy: A Randomized, Controlled Clinical Study. Clin J Pain. 2021 Oct 12;38(1):8-14. doi: 10.1097/AJP.0000000000000992.

  PMID: 34636753 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Rehab A Mahmoud, MSc

  Aswan University

  STUDY CHAIR

• Ayman M Eldemrdash

  Aswan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek s Hemaida, MD

CONTACT

0100 736 3190; dr.tarek@aswu.edu.eg

Soudy s Hammad, MD

CONTACT

+201014761523; soudi.salah@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In our randomized controlled trial, we employed masking (also called blinding) to reduce bias. Participants were unaware of whether they were receiving the intervention or control. Caregivers were instructed not to reveal this information, and outcome assessors who evaluated results were kept separate from intervention delivery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Model Details: These prospective, randomized, controlled clinical trials will be performed in Aswan University Hospital on 75 patients who are scheduled for kidney exploration surgeries

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 26, 2024
• Study Start: June 1, 2024
• Primary Completion: February 25, 2025
• Study Completion: March 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)