Clinical trial

Effects of Adding Dexmedetomidine to Bupivacaine for Bilateral Erector Spinae Block in Lumbar Fusion Surgeries

NCT06231979

Name

Erector Spinae Block

Description

The aim of this study is to compare the analgesic effect of bilateral US-guided ESPB using bupivacaine alone versus bupivacaine and DEX in lumbar fusion surgeries.

Trial arms

Trial start

2024-02-25

Estimated PCD

2025-01-01

Trial end

2025-10-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Dexmedetomidine

1 μg/kg Dexmedetomidine per side in erector spinae block

Arms:

Dexmedetomidine group

Other names:

DEX

Bupivacain

18 mL of bupivacaine 0.25 % per side in erector spinae block

Arms:

Bupivacaine group, Dexmedetomidine group

Other names:

Bup

Normal saline

2 ml normal saline 0.9% per side in erector spinae block

Arms:

Bupivacaine group

Other names:

Normal saline sodium chloride 0.9%

Size

Primary endpoint

the cummulative opioid consumption during first 48 h postoperatively.

48 hours postoperatively.

Eligibility criteria

Inclusion Criteria: * Patients of both genders * age between 18-65 years * American Society of Anesthesiologists (ASA) physical status I-II\*\* * scheduled for lumbar spine fusion surgeries ( 2 or 3 level lumbar fusion with or without decompression ) under general anesthesia . Exclusion Criteria: * Patient refusal. * Patient with chronic use of opioid analgesia. * Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment. * Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection). Known allergy to local anesthetics.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

Updated at

2024-01-30

1 organization

3 products

3 indications

Organization

Assiut University

Product

Dexmedetomidine

Indication

Paraspinal Muscles Block

Indication

Indication

Product

Product