Lumbar Spinal StenosisPhase 4NCT05871073
Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery
A Phase 4 study testing Ropivacaine 0.75% Injectable Solution and dexamethasone 8mg in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by University Hospital Fattouma Bourguiba at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis
- What is being tested?
- Ropivacaine 0.75% Injectable Solution and dexamethasone 8mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2023to 5 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery: A Randomized, Double-Blinded, Controlled Trial
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
- Being tested
- Ropivacaine 0.75% Injectable Solution, dexamethasone 8mg
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.75% Injectable SolutionDrug
Also called Alone
WOUND INFILTRATION AFTER SPINAL SURGERY
dexamethasone 8mgDrug
Also called with Ropivacaine 0.75% Injectable Solution
WOUND INFILTRATION AFTER SPINAL SURGERY
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine 0.75% Injectable Solution | Experimental | Wound Infiltration for Postoperative Analgesia After Spinal Surgery Receives: Drug: Ropivacaine 0.75% Injectable Solution |
| Dexamethasone 8mg | Experimental | Wound Infiltration for Postoperative Analgesia After Spinal Surgery Receives: Drug: Ropivacaine 0.75% Injectable Solution; Drug: dexamethasone 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 4, 6, 12, 24, and 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jan 2023
- Primary completion4 Feb 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Fattouma Bourguiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Ben Nsir, University Hospital Fattouma Bourguiba
- Investigators
- ATEF BEN NSIR, PHD, Study chair, HOPITAL UNIVERSITAIRE FATTOUMA BOURGUIBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871073
- Sponsor's protocol ID
- PAIN MANAGMENT IN SURGERY
- Status last verified
- May 2023
- First submitted
- 11 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery: A Randomized, Double-Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT05871073
- Acronym / sponsor ID
- PAIN MANAGMENT IN SURGERY
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Spondylolisthesis, Lumbar Spine Instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Fattouma BourguibaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 4 Feb 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine 0.75% Injectable Solution | Experimental | Drug: Ropivacaine 0.75% Injectable SolutionWound Infiltration for Postoperative Analgesia After Spinal Surgery |
| Dexamethasone 8mg | Experimental | Drug: Ropivacaine 0.75% Injectable Solution, Drug: dexamethasone 8mgWound Infiltration for Postoperative Analgesia After Spinal Surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.75% Injectable SolutionAlso: AloneWOUND INFILTRATION AFTER SPINAL SURGERY | Drug | Dexamethasone 8mg, Ropivacaine 0.75% Injectable Solution |
| dexamethasone 8mgAlso: with Ropivacaine 0.75% Injectable SolutionWOUND INFILTRATION AFTER SPINAL SURGERY | Drug | Dexamethasone 8mg |
Primary outcome
the time of the first analgesic demand of PCA
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ATEF BEN NSIR, PHD study chair
HOPITAL UNIVERSITAIRE FATTOUMA BOURGUIBA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine 0.75% Injectable Solution and dexamethasone 8mg in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by University Hospital Fattouma Bourguiba at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time of the first analgesic demand of PCA (time frame: at 4, 6, 12, 24, and 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.