Chronic PainPhase 3NCT02752477
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery
A Phase 3 study testing Opioid-free general anesthetic and Traditional general anesthetic in people with Chronic Pain and Anesthesia, run by Ben Lim at 1 site in Canada.
Trial summary
The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Anesthesia
- What is being tested?
- Opioid-free general anesthetic and Traditional general anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 2 Aug 2016to Sep 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain > 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery
Who cannot join
- Pregnant or breastfeeding women, significant hepatic, renal or cardiac disease, allergy to any of the study drugs, inability to consent, respond to pain assessments or use the patient controlled analgesia device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study
The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative opioid consumption and pain scores in CPPs.
- Conditions
- Chronic Pain, Anesthesia
- Being tested
- Opioid-free general anesthetic, Traditional general anesthetic
- Keywords
- Opioid-sparing
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-free general anestheticDrug
An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
Traditional general anestheticDrug
Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free anesthetic (OFA) group | Experimental | Not described Receives: Drug: Opioid-free general anesthetic |
| Traditional Anesthesia (TA) group | Active comparator | Not described Receives: Drug: Traditional general anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantified opioid-consumption
Measured: 48 hours following surgery
Secondary outcomes (3)
Visual analogue scale (VAS) pain scores
Measured: 48 hours following surgery
Time of stay in post-anesthetic care unit (PACU)
Measured: up to 5 hours following surgery
Incidence of adverse events
Measured: 48 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start2 Aug 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ben Lim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ben Lim, University of Saskatchewan
- Investigators
- Ben Lim, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752477
- Sponsor's protocol ID
- BIO15-253
- Status last verified
- Mar 2020
- First submitted
- 29 Mar 2016
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Opioid-free Anesthesia in Reducing Postoperative Pain in Chronic Pain Patients Undergoing Spinal Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT02752477
- Acronym / sponsor ID
- BIO15-253
- Conditions
- Chronic Pain, Anesthesia
- Keywords
- Opioid-sparing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ben LimUniversity, hospital or other
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- 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.
The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, and lidocaine infusions can help reduce postoperative pain in opiate-dependent chronic pain patients (CPPs) undergoing spine surgery when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative opioid consumption and pain scores in CPPs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-free anesthetic (OFA) group | Experimental | Drug: Opioid-free general anesthetic |
| Traditional Anesthesia (TA) group | Active comparator | Drug: Traditional general anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic pain > 6 months, opiate-using patients scheduled for thoracic or lumbar spinal surgery
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding women, significant hepatic, renal or cardiac disease, allergy to any of the study drugs, inability to consent, respond to pain assessments or use the patient controlled analgesia device
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 |
|---|---|---|
| Opioid-free general anestheticAn opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions | Drug | Opioid-free anesthetic (OFA) group |
| Traditional general anestheticTraditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil | Drug | Traditional Anesthesia (TA) group |
Primary outcome
Quantified opioid-consumption
Time frame: 48 hours following surgery
3 secondary outcomes
Visual analogue scale (VAS) pain scores
Time frame: 48 hours following surgery
Time of stay in post-anesthetic care unit (PACU)
Time frame: up to 5 hours following surgery
Incidence of adverse events
Time frame: 48 hours following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- 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.
Ben Lim, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Opioid-free general anesthetic and Traditional general anesthetic in people with Chronic Pain and Anesthesia, run by Ben Lim at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Quantified opioid-consumption (time frame: 48 hours following surgery). 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 26 Mar 2020.