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

NCT ID: NCT05664542

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2023-05-30

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups, one with block and other with no block
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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

Study Groups

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ESPB group

this group will receive ESPB using ropivacaine and dexmedetomidine

Group Type EXPERIMENTAL

ESPB (regional Block)

Intervention Type OTHER

ESPB is regional block in which we will use 0.2 % ropivacaine and dexmedetomidine

ropivacaine and dexmedetomidine

Intervention Type DRUG

0.2 % ropivacaine and dexmedetomidine

Control group

this group will not receive any block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ESPB (regional Block)

ESPB is regional block in which we will use 0.2 % ropivacaine and dexmedetomidine

Intervention Type OTHER

ropivacaine and dexmedetomidine

0.2 % ropivacaine and dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Security Forces Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anwar ul Huda

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anwar ul Huda, FRCA

Role: PRINCIPAL_INVESTIGATOR

Security Forces Hospital

Locations

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Security Forces Hospital

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Anwar ul huda, FRCA

Role: CONTACT

00966118024331 ext. 4331

Facility Contacts

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Anwar ul huda, FRCA

Role: primary

0502654719

Other Identifiers

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SFH-ESPB Dex

Identifier Type: -

Identifier Source: org_study_id

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