Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block

Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block Versus Bupivacaine Alone for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries

As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.

Study Overview

• Status: Completed
• Conditions: Posterior Lumbosacral Spine Fixation Surgeries
• Intervention / Treatment: Drug: Dexmedetomidine injection; Drug: Bupivacaine 0.25% Injectable Solution; Drug: normal saline

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12573
    • October 6 university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray

Exclusion Criteria:

• hypersensitivity to the drugs used in the study [local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)]
• patients with any contraindication to regional anesthesia as skin infections at the site of the block
• history of bleeding disorders or receiving anticoagulant medications

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine combined with bupivacaine group (DB group); patients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%,	Drug: Dexmedetomidine injection; 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%; Drug: Bupivacaine 0.25% Injectable Solution; 20 ml of bupivacaine 0.25%,
Active Comparator: bupivacaine 0.25%,; patients received 20 ml of bupivacaine 0.25%	Drug: Bupivacaine 0.25% Injectable Solution; 20 ml of bupivacaine 0.25%,
Placebo Comparator: control group (S group); patients received 20 ml of normal saline 0.9%.	Drug: normal saline; 20 ml of normal saline 0.9%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative visual analogue scale (VAS)	The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.	the first 24 hours postoperative
Amount of post operative opioid consumption for the first 24 hours	Amount of total opioid consumption for 24 hours postoperative	the first 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative visual analogue scale (VAS)	The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.	the second 24 hour postoperative
Amount of post operative opioid consumption for the second 24 hours	Amount of total opioid consumption for the second 24 hours postoperative	the second 24 hour postoperative

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Principal Investigator: Abdelmaksod Mohammed M Mousa, MD, October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• 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: PRC-Me-2210035

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