Baclofen as a Perioperative Analgesic Adjuvant

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 4

Conditions: Pain

Treatments: Other: Placebo; Drug: Baclofen 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03720717

IRB-300002466

Details and patient eligibility

About

The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 4 patient groups, including a placebo group

Opioid Tolerant - baclofen

Experimental group

Description:

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.

Treatment:

Drug: Baclofen 10mg

Opioid Tolerant - placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Opioid Naive - baclofen

Experimental group

Description:

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.

Treatment:

Drug: Baclofen 10mg

Opioid Naive - placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo