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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05871073
Other study ID # PAIN MANAGMENT IN SURGERY
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2023
Est. completion date March 5, 2023

Study information

Verified date May 2023
Source University Hospital Fattouma Bourguiba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 5, 2023
Est. primary completion date February 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Intervention

Drug:
Ropivacaine 0.75% Injectable Solution
WOUND INFILTRATION AFTER SPINAL SURGERY
dexamethasone 8mg
WOUND INFILTRATION AFTER SPINAL SURGERY

Locations

Country Name City State
Tunisia Hopital Fattouma Burguiba Monastir Monastir

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Fattouma Bourguiba

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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