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Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block

Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block Versus Bupivacaine Alone for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05590234
Enrollment
90
Registered
2022-10-21
Start date
2022-11-15
Completion date
2023-07-20
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Lumbosacral Spine Fixation Surgeries

Brief 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.

Interventions

DRUGDexmedetomidine injection

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

20 ml of bupivacaine 0.25%,

DRUGnormal saline

20 ml of normal saline 0.9%.

Sponsors

October 6 University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative visual analogue scale (VAS)the first 24 hours postoperativeThe visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Amount of post operative opioid consumption for the first 24 hoursthe first 24 hours postoperativeAmount of total opioid consumption for 24 hours postoperative

Secondary

MeasureTime frameDescription
Postoperative visual analogue scale (VAS)the second 24 hour postoperativeThe visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Amount of post operative opioid consumption for the second 24 hoursthe second 24 hour postoperativeAmount of total opioid consumption for the second 24 hours postoperative

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026