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

NCT05871073 | Completed Phase 4

• 1 other identifier: PAIN MANAGMENT IN SURGERY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis; Lumbar Disc Herniation; Lumbar Spondylolisthesis; Lumbar Spine Instability

Outcome Measures

Primary Outcomes (1)

• 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

  at 4, 6, 12, 24, and 48 hours postoperatively

Study Arms (2)

Ropivacaine 0.75% Injectable Solution

EXPERIMENTAL

Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Drug: Ropivacaine 0.75% Injectable Solution

Dexamethasone 8mg

EXPERIMENTAL

Wound Infiltration for Postoperative Analgesia After Spinal Surgery

Drug: Ropivacaine 0.75% Injectable Solution; Drug: dexamethasone 8mg

Interventions

Ropivacaine 0.75% Injectable Solution DRUG

WOUND INFILTRATION AFTER SPINAL SURGERY

Also known as: Alone

Dexamethasone 8mg; Ropivacaine 0.75% Injectable Solution

dexamethasone 8mg DRUG

WOUND INFILTRATION AFTER SPINAL SURGERY

Also known as: with Ropivacaine 0.75% Injectable Solution

Dexamethasone 8mg

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Fattouma Bourguiba: lead

Study Sites (1)

Hopital Fattouma Burguiba Monastir

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement; Spondylolisthesis

Interventions

Ropivacaine; Single Person; Dexamethasone

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• ATEF BEN NSIR, PHD

  HOPITAL UNIVERSITAIRE FATTOUMA BOURGUIBA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNIVERSITY OF MONAASTIR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 23, 2023
• Study Start: January 1, 2023
• Primary Completion: February 4, 2023
• Study Completion: March 5, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)