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

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
ESPB (regional Block)
ropivacaine and dexmedetomidine
Sponsored by
Security Forces Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Security Forces HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ESPB group

Control group

Arm Description

this group will receive ESPB using ropivacaine and dexmedetomidine

this group will not receive any block

Outcomes

Primary Outcome Measures

24 hours opioid consumption
opioid consumption in mg during first 4 hours postoperatively

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2022
Last Updated
February 21, 2023
Sponsor
Security Forces Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05664542
Brief Title
Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries
Official Title
Efficacy of Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries - A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Security Forces Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 groups, one with block and other with no block
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESPB group
Arm Type
Experimental
Arm Description
this group will receive ESPB using ropivacaine and dexmedetomidine
Arm Title
Control group
Arm Type
No Intervention
Arm Description
this group will not receive any block
Intervention Type
Other
Intervention Name(s)
ESPB (regional Block)
Intervention Description
ESPB is regional block in which we will use 0.2 % ropivacaine and dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
ropivacaine and dexmedetomidine
Intervention Description
0.2 % ropivacaine and dexmedetomidine
Primary Outcome Measure Information:
Title
24 hours opioid consumption
Description
opioid consumption in mg during first 4 hours postoperatively
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
pain score
Description
pain score in Numerical rating score during first 24 hours postoperatively
Time Frame
24 hours
Title
Occurrence of postoperative nausea and vomiting (PONV)
Description
Occurrence of postoperative nausea and vomiting (PONV) during first 24 hours
Time Frame
24 hours
Title
Occurrence of drowsiness
Description
Occurrence of drowsiness in 24 hours will be recorded
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anwar ul huda, FRCA
Phone
00966118024331
Ext
4331
Email
hudaanwar90@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anwar ul Huda, FRCA
Organizational Affiliation
Security Forces Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Security Forces Hospital
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anwar ul huda, FRCA
Phone
0502654719

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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