Systemic Versus Local Dexmedetomidine As an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block

Systemic Versus Local Dexamedetomedine As an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block in Kidney Exploration Surgeries ,A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Erector Spinae Block
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Dexmedetomidine Injection [Precedex]; Drug: Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)

Detailed Description

Open Kidney surgeries remain one of the approaches used for those patients are requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain for months following surgery.

Effective treatment of postoperative pain allows early mobilization of the patient, shortens the recovery and discharge time, prevents the development of chronic pain, and increases satisfaction and long-term quality of life.

Current modalities used to manage pain for patients undergoing kidney exploration include oral and parenteral opioid administration, local anesthetic infiltration, and certain neuraxial and regional anesthesia procedures including thoracic epidurals and paravertebral blocks.

The erector spinae plane (ESP) block is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. The technique is relatively easy to perform on patients, and it is performable with minimal or no sedation in the pre-operative holding area.

Ultrasound is a non-invasive visualization technology that helps capture the anatomical structure of target tissues; it can help guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications.

The local anesthetic drugs have a limited duration of action, so we need to add adjuvants such as opioids, alpha two agonists, neostigmine, or magnesium.

Dexmedetomidine is a potent α2 agonist and is a powerful adjuvant to regional anesthesia and analgesia. It can prolong the duration of the nerve block anesthesia resulting in increased effectiveness of the block in terms of duration, less use of opioids, and shorter hospital stay in the absence of clinically significant side effects (hypotension, nausea, vomiting, and pruritus.

Adding adjuvants to local anesthetics is frequently used to prolong the duration of single-injection regional nerve block.

There have been multiple studies claiming increased effectiveness of use of dexmedetomidine and this has been consolidated in a meta-analysis examining the effectiveness of dexamedetomedine as a peripheral nerve block adjuvant.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Soudy S Hammad, MD; Phone Number: +201014761523; Email: soudi.salah@aswu.edu.eg
• Study Contact Backup: Name: Tarek s Hemaida, MD; Phone Number: 0100 736 3190; Email: dr.tarek@aswu.edu.eg

Study Locations

• Egypt
  • Aswan, Egypt, 81511
    • Recruiting
    • Aswan University
    • Contact: Soudy S Hammad; Phone Number: +201014761523; Email: soudi.salah@aswu.edu.eg
    • Contact: Tarek S Hemaida; Phone Number: 01007363190; Email: dr.tarek@aswu.edu.eg
    • Contact: Rehab A Mahmoud, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

•. kidney exploration surgeries.

• ASA I/II patients.
• BMI <35

Exclusion Criteria:

• 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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Ι Block only (group BO) (control group); 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 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
Active Comparator: Group ΙI (group DL): 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 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
Active Comparator: Group III (group D IV): 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period .	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	amsay Sedation Scale (RSS) The RSS is a user-friendly and therefore commonly used sedation scale, with scores ranging from +4 (a violent dangerous patient) to -5 (an unarousable patient).6 A sedation score of 0 is most often therapeutically targeted, as it correlates with an alert and calm patient.	at 1, 3, 6, 12, 24, 36 and 48 hours
Intraoperative hemodynamic parameters blood pressure	blood pressure measurement obtained by non-invasive blood pressure cuff during intraoperative and postoperative in PACU expressed in mmhg	at 1, 3, 6, hours
Minimum alveolar concentration (MAC) requirements	Minimum alveolar concentration or MAC is the concentration, often expressed as a percentage by volume, of a vapour in the alveoli of the lungs that is needed to prevent movement (motor response) in 50% of subjects in response to surgical (pain) stimulus.	during intraoperative periods expressed in minutes

Collaborators and Investigators

• Sponsor: Aswan University
• Investigators: Study Chair: Rehab A Mahmoud, MSc, Aswan University; Principal Investigator: Ayman M Eldemrdash, Aswan University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): February 25, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Bupivacaine; kidney exploration surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Bupivacaine; Dexmedetomidine
• Other Study ID Numbers: Asw.U./742 /2/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No