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Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery

Primary Purpose

Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis

Status
Completed
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Ropivacaine 0.75% Injectable Solution
dexamethasone 8mg
Sponsored by
University Hospital Fattouma Bourguiba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA I or II and diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar degenerative spondylolisthesis requiring surgical treatment such as lumbar laminectomy and/or lumbar osteosynthesis. Exclusion Criteria: Patients with altered communication capacity, previous spinal surgery, neuropathic pain, allergy to opioids, dexamethasone, or local anesthetics, active infection or tumor history, traumatic injury, chronic use of steroids or opioids, severe kidney, hepatic, or pulmonary failure, delayed extubation in post-anesthesia care unit (PACU), major bleeding during or after surgery, or surgical revision within the first 24 hours were excluded from the study.

Sites / Locations

  • Hopital Fattouma Burguiba Monastir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ropivacaine 0.75% Injectable Solution

Dexamethasone 8mg

Arm Description

Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Outcomes

Primary Outcome Measures

the time of the first analgesic demand of PCA
Change of VAS scores at 4, 6, 12, 24, and 48 hours postoperatively were also assessed by the patients after they had recovered from anesthesia

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
May 13, 2023
Sponsor
University Hospital Fattouma Bourguiba
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1. Study Identification

Unique Protocol Identification Number
NCT05871073
Brief Title
Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery
Official Title
Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery: A Randomized, Double-Blinded, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 4, 2023 (Actual)
Study Completion Date
March 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Fattouma Bourguiba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Introduction: Improving postoperative pain management after spinal surgery is a significant challenge for surgeons and anesthesiologists. Pain following spinal surgery, can lead to significant morbidity, limit early mobility, and increase the risk of chronic pain. This trial examines the analgesic effects of dexamethasone as an adjuvant to ropivacaine in wound infiltration after lumbar surgery. Methods: In this study, we randomly assigned sixty patients undergoing lumbar laminectomy and/or osteosynthesis into two groups of 30 patients each. The control group (R-group) received only Ropivacaine (150 mg of Ropivacaine 7.5% (20 ml) added to 2 ml of normal saline in the wound infiltration), while the intervention group (RD-group) received Ropivacaine with the addition of dexamethasone (150 mg of Ropivacaine 7.5% (20 ml) added to 8 mg of dexamethasone in the wound infiltration). Both groups were administered patient-controlled analgesia (PCA) with morphine for self-medication. Postoperatively, a blinded evaluator assessed pain at H0, recorded the assessment of surgical scar pain using the Visual Analog Scale (VAS) at 4, 6, 12, 24, and 48 hours, as well as the time to the first opioid request, cumulative morphine consumption, opioid-related side effects, and length of stay. All patients were scheduled for a 3-month follow-up call to monitor chronic pain progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbar Spine Instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine 0.75% Injectable Solution
Arm Type
Experimental
Arm Description
Wound Infiltration for Postoperative Analgesia After Spinal Surgery
Arm Title
Dexamethasone 8mg
Arm Type
Experimental
Arm Description
Wound Infiltration for Postoperative Analgesia After Spinal Surgery
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.75% Injectable Solution
Other Intervention Name(s)
Alone
Intervention Description
WOUND INFILTRATION AFTER SPINAL SURGERY
Intervention Type
Drug
Intervention Name(s)
dexamethasone 8mg
Other Intervention Name(s)
with Ropivacaine 0.75% Injectable Solution
Intervention Description
WOUND INFILTRATION AFTER SPINAL SURGERY
Primary Outcome Measure Information:
Title
the time of the first analgesic demand of PCA
Description
Change of VAS scores at 4, 6, 12, 24, and 48 hours postoperatively were also assessed by the patients after they had recovered from anesthesia
Time Frame
at 4, 6, 12, 24, and 48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I or II and diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar degenerative spondylolisthesis requiring surgical treatment such as lumbar laminectomy and/or lumbar osteosynthesis. Exclusion Criteria: Patients with altered communication capacity, previous spinal surgery, neuropathic pain, allergy to opioids, dexamethasone, or local anesthetics, active infection or tumor history, traumatic injury, chronic use of steroids or opioids, severe kidney, hepatic, or pulmonary failure, delayed extubation in post-anesthesia care unit (PACU), major bleeding during or after surgery, or surgical revision within the first 24 hours were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ATEF BEN NSIR, PHD
Organizational Affiliation
HOPITAL UNIVERSITAIRE FATTOUMA BOURGUIBA
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Fattouma Burguiba Monastir
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery

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