Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-07-20

Brief Summary

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As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.

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Detailed Description

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Conditions

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Posterior Lumbosacral Spine Fixation Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexmedetomidine combined with bupivacaine group (DB group)

patients received 1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%,

Group Type ACTIVE_COMPARATOR

Dexmedetomidine injection

Intervention Type DRUG

1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%

Bupivacaine 0.25% Injectable Solution

Intervention Type DRUG

20 ml of bupivacaine 0.25%,

bupivacaine 0.25%,

patients received 20 ml of bupivacaine 0.25%

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25% Injectable Solution

Intervention Type DRUG

20 ml of bupivacaine 0.25%,

control group (S group)

patients received 20 ml of normal saline 0.9%.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

20 ml of normal saline 0.9%.

Interventions

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Dexmedetomidine injection

1ug/kg dexmedetomidine plus 20 mL of bupivacaine 0.25%

Intervention Type DRUG

Bupivacaine 0.25% Injectable Solution

20 ml of bupivacaine 0.25%,

Intervention Type DRUG

normal saline

20 ml of normal saline 0.9%.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray

Exclusion Criteria

* hypersensitivity to the drugs used in the study \[local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)\]
* patients with any contraindication to regional anesthesia as skin infections at the site of the block
* history of bleeding disorders or receiving anticoagulant medications

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No