Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries

Phase 4

Recruiting

• Conditions: Postoperative Pain
• Interventions: Other: ESPB (regional Block); Drug: ropivacaine and dexmedetomidine

• Registration Number: NCT05664542
• Lead Sponsor: Security Forces Hospital

Brief Summary

The aim of this study is to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block in reducing opioid consumption for patients undergoing lumbar spine surgeries. This study will help in understanding the role of adding dexmdetomidine to ropivacaine in erector spinae block in reducing opioid consumption after lumbar spine surgeries

Detailed Description

A number of adjuvants have been used with local anesthetics including dexamethasone, nalbuphine and dexmedetomidine etc with the aim of improving quality and duration of peripheral nerve blocks. Dexmedetomidine is a potent alpha-2 agonist which can prolong the duration of regional anesthesia block when used in combination with local anesthetics. Although, there is no consensus on the dose of dexmedetomidine for peripheral nerve block considering the fact that it can lower heart rate and blood pressure intraoperatively. Investigators therefore, planned this randomised controlled trial to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block for patients undergoing lumbar spine surgeries.

Study Timeline

• Study First Submitted: 2022-11-20
• Study Start: 2022-12-15
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2022-12-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients aged between 18 and 70 years, scheduled to undergo lumbar spine surgeries with an ASA score of 1 to 3 will be included in the study

Exclusion Criteria

• Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics or dexmedetomidine, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications will not be included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESPB group	ropivacaine and dexmedetomidine	this group will receive ESPB using ropivacaine and dexmedetomidine
ESPB group	ESPB (regional Block)	this group will receive ESPB using ropivacaine and dexmedetomidine

Primary Outcome Measures

Name	Time	Method
24 hours opioid consumption	24 hours	opioid consumption in mg during first 4 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Occurrence of postoperative nausea and vomiting (PONV)	24 hours	Occurrence of postoperative nausea and vomiting (PONV) during first 24 hours
pain score	24 hours	pain score in Numerical rating score during first 24 hours postoperatively
Occurrence of drowsiness	24 hours	Occurrence of drowsiness in 24 hours will be recorded

Trial Locations

Locations (1)

Security Forces Hospital; 🇸🇦 Riyadh, Saudi Arabia