PainPhase 4NCT03720717
Baclofen as a Perioperative Analgesic Adjuvant
A Phase 4 study testing Baclofen 10mg in people with Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Baclofen 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 28 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age >= 19 y.o.) scheduled for kidney stone-related surgery
- Exclusion Criteria: (note - there were no patients requiring exclusion)
- History of allergy to baclofen
- Any condition which might limit appropriate report and treatment of postoperative pain (e.g., non-English speaking; severe psychiatric disease)
- Active history of cancer
- Potential for difficult airway as judged by attending anesthesiologist due to concerns there could be muscle weakness from the drug with consequent respiratory depression
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.
Read the detailed description
Postoperative pain continues to be a significant clinical problem. Use of perioperative adjuvants has improved postoperative pain control. The GABA-B receptor agonist, baclofen, is an appropriate drug to trial as such an analgesic adjuvant. Therefore, the investigators will conduct a study designed to determine whether or not a single, oral dose of baclofen given to patients undergoing kidney stone surgery will reduce postoperative opioid requirements measured in the first 24 hours following surgery.
- Conditions
- Pain
- Being tested
- Baclofen 10mg, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen 10mgDrug
Also called Lioresol
Baclofen administration pre-operatively
PlaceboOther
Placebo administration
| Study group | Role | What they receive |
|---|---|---|
| Opioid Tolerant - baclofen | Experimental | Patients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry. Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. Receives: Drug: Baclofen 10mg |
| Opioid Tolerant - placebo | Placebo comparator | Patients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. Receives: Other: Placebo |
| Opioid Naive - baclofen | Experimental | Patients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. Receives: Drug: Baclofen 10mg |
| Opioid Naive - placebo | Placebo comparator | Patients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Requirements
Patients Patients' opioid requirements for acceptable pain control will be assessed based on the total oral morphine equivalent needed for post operative pain control.
Measured: From 0 hours post-operatively to 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start27 Oct 2020
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Why it stopped: Futility analysis at midpoint analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Coded envelopes with study drug/placebo had been generated and randomized. Patients were enrolled and given drug in next envelope. After completion of study patients assigned into opioid-naive or daily opioid-tolerant groups based on history given by patient
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Ness, MD, University of Alabama at Birmingham
- Investigators
- Mark Mandabach, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720717
- Sponsor's protocol ID
- IRB-300002466
- Status last verified
- Aug 2024
- First submitted
- 24 Oct 2018
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data available on reasonable request - currently in RedCap system
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baclofen as a Perioperative Analgesic Adjuvant
- ClinicalTrials.gov ID
- NCT03720717
- Acronym / sponsor ID
- IRB-300002466
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility analysis at midpoint analysis
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.
Detailed description
Postoperative pain continues to be a significant clinical problem. Use of perioperative adjuvants has improved postoperative pain control. The GABA-B receptor agonist, baclofen, is an appropriate drug to trial as such an analgesic adjuvant. Therefore, the investigators will conduct a study designed to determine whether or not a single, oral dose of baclofen given to patients undergoing kidney stone surgery will reduce postoperative opioid requirements measured in the first 24 hours following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Coded envelopes with study drug/placebo had been generated and randomized. Patients were enrolled and given drug in next envelope. After completion of study patients assigned into opioid-naive or daily opioid-tolerant groups based on history given by patient
| Arm | Type | Receives |
|---|---|---|
| Opioid Tolerant - baclofen | Experimental | Drug: Baclofen 10mgPatients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry. Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. |
| Opioid Tolerant - placebo | Placebo comparator | Other: PlaceboPatients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. |
| Opioid Naive - baclofen | Experimental | Drug: Baclofen 10mgPatients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. |
| Opioid Naive - placebo | Placebo comparator | Other: PlaceboPatients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (age >= 19 y.o.) scheduled for kidney stone-related surgery
- Exclusion Criteria: (note - there were no patients requiring exclusion)
- History of allergy to baclofen
- Any condition which might limit appropriate report and treatment of postoperative pain (e.g., non-English speaking; severe psychiatric disease)
- Active history of cancer
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Baclofen 10mgAlso: LioresolBaclofen administration pre-operatively | Drug | Opioid Naive - baclofen, Opioid Tolerant - baclofen |
| PlaceboPlacebo administration | Other | Opioid Naive - placebo, Opioid Tolerant - placebo |
Primary outcome
Postoperative Opioid Requirements
Time frame: From 0 hours post-operatively to 24 hours post-operatively
Patients Patients' opioid requirements for acceptable pain control will be assessed based on the total oral morphine equivalent needed for post operative pain control.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual data available on reasonable request - currently in RedCap system
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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.
Mark Mandabach, MD principal investigator
University of Alabama at Birmingham
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 Baclofen 10mg in people with Pain, run by University of Alabama at Birmingham at 1 site in United States.
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 6 inclusion and 0 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: stopped early, as of the sponsor's last update on 5 Sep 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Opioid Requirements (time frame: From 0 hours post-operatively to 24 hours post-operatively). 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 5 Sep 2024.