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

Sponsor

University Hospital Fattouma Bourguiba (Other)

Overall Status

Completed

CT.gov ID

NCT05871073

Collaborator

(none)

Enrollment

Location

Arms

2.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spinal Stenosis Lumbar Disc Herniation Lumbar Spondylolisthesis Lumbar Spine Instability	Drug: Ropivacaine 0.75% Injectable Solution Drug: dexamethasone 8mg	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery: A Randomized, Double-Blinded, Controlled Trial

Actual Study Start Date :

Jan 1, 2023

Actual Primary Completion Date :

Feb 4, 2023

Actual Study Completion Date :

Mar 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ropivacaine 0.75% Injectable Solution Wound Infiltration for Postoperative Analgesia After Spinal Surgery	Drug: Ropivacaine 0.75% Injectable Solution WOUND INFILTRATION AFTER SPINAL SURGERY Other Names: Alone
Experimental: Dexamethasone 8mg Wound Infiltration for Postoperative Analgesia After Spinal Surgery	Drug: Ropivacaine 0.75% Injectable Solution WOUND INFILTRATION AFTER SPINAL SURGERY Other Names: Alone Drug: dexamethasone 8mg WOUND INFILTRATION AFTER SPINAL SURGERY Other Names: with Ropivacaine 0.75% Injectable Solution

Arm

Intervention/Treatment

Experimental: Ropivacaine 0.75% Injectable Solution

Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Drug: Ropivacaine 0.75% Injectable Solution

WOUND INFILTRATION AFTER SPINAL SURGERY

Other Names:

Alone

Experimental: Dexamethasone 8mg

Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Drug: Ropivacaine 0.75% Injectable Solution

WOUND INFILTRATION AFTER SPINAL SURGERY

Other Names:

Alone

Drug: dexamethasone 8mg

WOUND INFILTRATION AFTER SPINAL SURGERY

Other Names:

with Ropivacaine 0.75% Injectable Solution

Outcome Measures

Primary Outcome Measures

the time of the first analgesic demand of PCA [at 4, 6, 12, 24, and 48 hours postoperatively]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.