Pain
Conditions
Brief summary
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.
Interventions
DRUGBaclofen 10mg
Baclofen administration pre-operatively
OTHERPlacebo
Placebo administration
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Coded envelopes as described above
Intervention 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
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Requirements | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Opioid Tolerant - Baclofen 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.
Baclofen 10mg: Baclofen administration pre-operatively | 5 |
| Opioid Tolerant - Placebo 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.
Placebo: Placebo administration | 7 |
| Opioid Naive - Baclofen 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.
Baclofen 10mg: Baclofen administration pre-operatively | 12 |
| Opioid Naive - Placebo 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.
Placebo: Placebo administration | 10 |
| Total | 34 |
Baseline characteristics
| Characteristic | Opioid Tolerant - Baclofen | Total | Opioid Naive - Placebo | Opioid Naive - Baclofen | Opioid Tolerant - Placebo |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 30 Participants | 8 Participants | 11 Participants | 6 Participants |
| Age, Continuous | 49.6 years STANDARD_DEVIATION 11.6 | 49.7 years STANDARD_DEVIATION 16 | 46.6 years STANDARD_DEVIATION 19.4 | 51.5 years STANDARD_DEVIATION 16.6 | 45.3 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 34 Participants | 10 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Opioid use - >=30 Oral morphine equivalents consumed per day | 5 Participants | 34 Participants | 10 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 2 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 27 Participants | 8 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 5 participants | 34 participants | 10 participants | 12 participants | 7 participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 3 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 18 Participants | 7 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 7 | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 5 | 0 / 7 | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 | 0 / 12 | 0 / 10 |
Outcome results
Primary
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.
Time frame: From 0 hours post-operatively to 24 hours post-operatively
Population: patients were stratified according to preprocedure opioid use into Opioid Tolerant and Opioid Naive groups based on above stated criteria
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid Tolerant - Baclofen | Postoperative Opioid Requirements | 85.5 mg oral morphine equivatents in 24 hours | Standard Error 33.6 |
| Opioid Tolerant - Placebo | Postoperative Opioid Requirements | 96.8 mg oral morphine equivatents in 24 hours | Standard Error 17.1 |
| Opioid Naive - Baclofen | Postoperative Opioid Requirements | 69.9 mg oral morphine equivatents in 24 hours | Standard Error 10 |
| Opioid Naive - Placebo | Postoperative Opioid Requirements | 40.4 mg oral morphine equivatents in 24 hours | Standard Error 11.7 |