NCT05590234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

October 17, 2022

Last Update Submit

July 20, 2023

Conditions

Posterior Lumbosacral Spine Fixation Surgeries

Outcome Measures

Primary Outcomes (2)

  • Postoperative visual analogue scale (VAS)

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

    the first 24 hours postoperative

  • Amount of post operative opioid consumption for the first 24 hours

    Amount of total opioid consumption for 24 hours postoperative

    the first 24 hours postoperative

Secondary Outcomes (2)

  • Postoperative visual analogue scale (VAS)

    the second 24 hour postoperative

  • Amount of post operative opioid consumption for the second 24 hours

    the second 24 hour postoperative

Study Arms (3)

Dexmedetomidine combined with bupivacaine group (DB group)

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine injectionDrug: Bupivacaine 0.25% Injectable Solution

bupivacaine 0.25%,

ACTIVE COMPARATOR

patients received 20 ml of bupivacaine 0.25%

Drug: Bupivacaine 0.25% Injectable Solution

control group (S group)

PLACEBO COMPARATOR

patients received 20 ml of normal saline 0.9%.

Drug: normal saline

Interventions

Dexmedetomidine injectionDRUG

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

Dexmedetomidine combined with bupivacaine group (DB group)
Bupivacaine 0.25% Injectable SolutionDRUG

20 ml of bupivacaine 0.25%,

Dexmedetomidine combined with bupivacaine group (DB group)bupivacaine 0.25%,
normal salineDRUG

20 ml of normal saline 0.9%.

control group (S group)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 university hospital

Giza, 12573, Egypt

Location

Related Publications (1)

  • Abu El Hassan SHA, Wahsh EA, Mousa AM, Ibrahim ARN, Mohammed EL. Comparative Study Between Dexmedetomidine with Bupivacaine and Bupivacaine Alone in Erector Spinae Plane Block for Postoperative Pain Control of Posterior Lumbosacral Spine Fixation Surgeries: A Randomized Controlled Trial. Drug Des Devel Ther. 2024 Feb 7;18:351-363. doi: 10.2147/DDDT.S444485. eCollection 2024.

    PMID: 38344257DERIVED

MeSH Terms

Interventions

DexmedetomidineBupivacaineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Abdelmaksod Mohammed M Mousa, MD

    October 6 University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of clinical pharmacy

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 21, 2022

Study Start

November 15, 2022

Primary Completion

July 1, 2023

Study Completion

July 20, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)