CClinicalTrials.gg
Sign In
CompletedNCT05590234Updated Jul 21, 2023

Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block

A Phase 1/2 interventional study of Dexmedetomidine injection and Bupivacaine 0.25% Injectable Solution in Posterior Lumbosacral Spine Fixation Surgeries, sponsored by October 6 University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by October 6 University · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Posterior Lumbosacral Spine Fixation Surgeries
03

In context

Lead sponsor

October 6 University is the lead sponsor of 136 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Dexmedetomidine combined with bupivacaine group (DB group)

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

    Drug: Dexmedetomidine injection · Drug: Bupivacaine 0.25% Injectable Solution

  • Active comparator
    bupivacaine 0.25%,

    patients received 20 ml of bupivacaine 0.25%

    Drug: Bupivacaine 0.25% Injectable Solution

  • Placebo comparator
    control group (S group)

    patients received 20 ml of normal saline 0.9%.

    Drug: normal saline

Interventions

  • DrugDexmedetomidine injection

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

  • DrugBupivacaine 0.25% Injectable Solution

    20 ml of bupivacaine 0.25%,

  • Drugnormal saline

    20 ml of normal saline 0.9%.

06

What researchers measure

Primary outcomes

  1. Postoperative visual analogue scale (VAS)

    The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.

    Time frame: the first 24 hours postoperative

  2. Amount of post operative opioid consumption for the first 24 hours

    Amount of total opioid consumption for 24 hours postoperative

    Time frame: the first 24 hours postoperative

Secondary outcomes

  1. Postoperative visual analogue scale (VAS)

    The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.

    Time frame: the second 24 hour postoperative

  2. Amount of post operative opioid consumption for the second 24 hours

    Amount of total opioid consumption for the second 24 hours postoperative

    Time frame: the second 24 hour postoperative

07

Study locations

1 site
  • October 6 university hospital
    Giza, 12573, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05590234
Lead sponsor
October 6 University
Responsible party
engy wahsh (lecturer of clinical pharmacy, October 6 University) — Principal investigator
First posted
Oct 21, 2022
Start date
Nov 15, 2022
Primary completion
Jul 1, 2023
Completion
Jul 20, 2023
Last update
Jul 21, 2023

Study contacts

Abdelmaksod Mohammed M Mousa, MD
principal investigator · October 6 University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

October 6 University

Start the discussion