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

Postoperative Pain Clinical Trial

Official title:

Efficacy of Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries - A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664542
• Other study ID #: SFH-ESPB Dex
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: February 2023
• Source: Security Forces Hospital
• Contact: Anwar ul huda, FRCA
• Phone: 00966118024331
• Email: hudaanwar90[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• ESPB (regional Block)
ESPB is regional block in which we will use 0.2 % ropivacaine and dexmedetomidine

Drug:
• ropivacaine and dexmedetomidine
0.2 % ropivacaine and dexmedetomidine

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Security Forces Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours opioid consumption	opioid consumption in mg during first 4 hours postoperatively	24 hours
Secondary	pain score	pain score in Numerical rating score during first 24 hours postoperatively	24 hours
Secondary	Occurrence of postoperative nausea and vomiting (PONV)	Occurrence of postoperative nausea and vomiting (PONV) during first 24 hours	24 hours
Secondary	Occurrence of drowsiness	Occurrence of drowsiness in 24 hours will be recorded	24 hours