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

• Sponsor: Security Forces Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05664542
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.5
• Patients Per Site Per Month: 7.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Other: ESPB (regional Block); Drug: ropivacaine and dexmedetomidine	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2 groups, one with block and other with no block2 groups, one with block and other with no block
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Procedure will be done after patient will undergo GA for surgery. Medications will be prepared by anesthetist not involved in the study. The nurse/doctor who will assess the outcome will not know the group allocation
• Primary Purpose: Prevention
• Official Title: Efficacy of Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries - A Randomised Controlled Trial
• Anticipated Study Start Date: Dec 15, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESPB group this group will receive ESPB using ropivacaine and dexmedetomidine	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
No Intervention: Control group this group will not receive any block

Outcome Measures

Primary Outcome Measures

1. 24 hours opioid consumption [24 hours]

   opioid consumption in mg during first 4 hours postoperatively

Secondary Outcome Measures

1. pain score [24 hours]

   pain score in Numerical rating score during first 24 hours postoperatively

2. Occurrence of postoperative nausea and vomiting (PONV) [24 hours]

   Occurrence of postoperative nausea and vomiting (PONV) during first 24 hours

3. Occurrence of drowsiness [24 hours]

   Occurrence of drowsiness in 24 hours will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Security Forces Hospital	Riyadh		Saudi Arabia

Sponsors and Collaborators

• Security Forces Hospital

Investigators

• Principal Investigator: Anwar ul Huda, FRCA, Security Forces Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anwar ul Huda, Principal investigator, Security Forces Hospital
• ClinicalTrials.gov Identifier: NCT05664542
• Other Study ID Numbers: SFH-ESPB Dex
• First Posted: Dec 23, 2022
• Last Update Posted: Dec 23, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Pain, Postoperative; Dexmedetomidine; Ropivacaine

Study Results

No Results Posted as of Dec 23, 2022