Adding Dexmedetomidine to Bupivacaine for Bilateral Erector Spinae Block

NCT06231979 | Unknown Phase 4

• 1 other identifier: Erector Spinae Block
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Erector Spinae Block; Lumbar Fusion Surgeries; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• the cummulative opioid consumption during first 48 h postoperatively.

  48 hours postoperatively.

Secondary Outcomes (2)

• Change in stress marker Super Oxide Dismutase (SOD) .

  24 hours postoperative.

• Postoperative pain score using Visual Analogue Scale (VAS).

  immediately postoperative

Other Outcomes (1)

• Change in stress marker Glutathione peroxidase 1

  24 hours postoperative.

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Patients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 1 μg/kg DEX diluted with saline to reach total volume 20 mL per side.

Drug: Dexmedetomidine; Drug: Bupivacain

Bupivacaine group

EXPERIMENTAL

Patients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 2 mL normal saline 0.9 % per side as control group.

Drug: Bupivacain; Drug: Normal saline

Interventions

Dexmedetomidine DRUG

1 μg/kg Dexmedetomidine per side in erector spinae block

Also known as: DEX

Dexmedetomidine group

Bupivacain DRUG

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

Also known as: Bup

Bupivacaine group; Dexmedetomidine group

Normal saline DRUG

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

Also known as: Normal saline sodium chloride 0.9%

Bupivacaine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (22)

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MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistent lecture

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 30, 2024
• Study Start: February 25, 2024
• Primary Completion: January 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01