Post-operative Pain
Conditions
Brief summary
Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly obese patients undergoing laparoscopic gastric bypass surgery.
Detailed description
Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been multiple studies evaluating its use in pre and post-operative pain control in various surgeries. Post-operative pain control is a challenging problem in bariatric patients due to the high doses of narcotic required, related to the high body mass, and the danger of concomitant respiratory depression. In the obese patient, the goal of postoperative pain management is provision of comfort, early mobilization and improved respiratory function, without causing inadequate pain control, respiratory compromise or increased nausea. Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo. We plan to follow their immediate post-operative course in the hospital, with regard to the following primary endpoints: * Post-operative analgesic requirements * Post-operative pain scale (rated 0-10) * Episodes of vomiting * Post-operative antiemetic requirement * Length of stay
Interventions
DRUGPregabalin
One 300 mg oral dose of Pregabalin given before surgery.
One oral dose of placebo given before surgery.
Sponsors
Legacy Health System
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative Pain Medication Requirements | Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Days in hospital following surgical procedure, up to 5 days | Length of stay in days after surgical procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Single, 300 mg pre-operative oral dose of Pregabalin.
Pregabalin: One 300 mg oral dose of Pregabalin given before surgery. | 28 |
| Sugar Pill Single, placebo pre-operative dose.
Placebo (for Pregabalin): One oral dose of placebo given before surgery. | 33 |
| Total | 61 |
Baseline characteristics
| Characteristic | Pregabalin | Sugar Pill | Total |
|---|---|---|---|
| Age, Continuous | 48.89 years STANDARD_DEVIATION 9.77 | 50.74 years STANDARD_DEVIATION 13.66 | 49.91 years STANDARD_DEVIATION 12.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 26 Participants | 46 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 33 |
| other Total, other adverse events | 0 / 28 | 0 / 33 |
| serious Total, serious adverse events | 0 / 28 | 0 / 33 |
Outcome results
Primary
Post-operative Pain Medication Requirements
Time frame: Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Post-operative Pain Medication Requirements | POD 0 | 13.76 MME | Standard Deviation 11.61 |
| Pregabalin | Post-operative Pain Medication Requirements | POD 1 | 40.89 MME | Standard Deviation 28.71 |
| Pregabalin | Post-operative Pain Medication Requirements | POD 2 | 33.62 MME | Standard Deviation 27.6 |
| Sugar Pill | Post-operative Pain Medication Requirements | POD 0 | 17.32 MME | Standard Deviation 9.15 |
| Sugar Pill | Post-operative Pain Medication Requirements | POD 1 | 46.63 MME | Standard Deviation 30.67 |
| Sugar Pill | Post-operative Pain Medication Requirements | POD 2 | 29.74 MME | Standard Deviation 26.08 |
p-value: 0.1t-test, 1 sided
Comparison: POD 1p-value: 0.23t-test, 1 sided
Comparison: POD 2p-value: 0.31t-test, 1 sided
Secondary
Length of Stay
Length of stay in days after surgical procedure
Time frame: Days in hospital following surgical procedure, up to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Length of Stay | 2.19 Days | Standard Deviation 0.47 |
| Sugar Pill | Length of Stay | 2.24 Days | Standard Deviation 0.6 |