Postoperative Pain
Conditions
Keywords
laparoscopy, postoperative pain, gynecology, gabapentin
Brief summary
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. The investigators hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin.
Detailed description
The purpose of this study is to prospectively determine the influence of immediate pre-operative gabapentin administration on acute postoperative pain. We hypothesize that immediate post-operative pain will be improved with pre-operative administration of gabapentin. We plan to conduct a prospective randomized trial to assess the effect of a single immediate pre-operative dose of gabapentin 300mg on immediate post-operative pain in patients undergoing laparoscopy for gynecologic indications. This concept has been studied in patients undergoing abdominal hysterectomy. We aim to study the effect on patients undergoing laparoscopy.
Interventions
DRUGGabapentin
Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
OTHERPlacebo
Patient will receive placebo tab less than 1 hour before surgery
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. The patient must be female and planning to have a laparoscopic or robotic assisted procedure for benign gynecologic indications. 2. Patients must be treated in the department of Obstetrics and Gynecology in the division of Minimally Invasive Gynecologic Surgery. 3. The patient must be in the age range of 18-80 years, in general good health and able to comply with study procedures.
Exclusion criteria
1. Male patients will be excluded from this study. 2. Patients under 18 years old will be excluded from this study. 3. Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude pregnancy. 4. Patients having abdominal, vaginal or hysteroscopic procedures 5. Allergy to gabapentin 6. Chronic use of gabapentin (greater than 6 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS (Numerical Rating Scale) | 2-8 hours | The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analog Scale) | 2 -6 hours | The VAS is scored using a horizontal line 100mm in length. The scale is anchored by no pain (score of 0) and worst pain (score of 100). |
| Total Morphine Consumption | 12 hours post-operatively | — |
Countries
United States
Participant flow
Recruitment details
A total of 125 patients consented to the study, but 13 did not undergo surgery or rescheduled.
Pre-assignment details
A total of 112 patients were enrolled, but 3 did not receive study drug.
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Patients will receive Gabapentin 300mg tab less than 1 hour before surgery. | 55 |
| Placebo Patients will receive Methylcellulose based placebo tab less than 1 hour before surgery. | 54 |
| Total | 109 |
Baseline characteristics
| Characteristic | Gabapentin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 9.8 | 39.5 years STANDARD_DEVIATION 9.4 | 39.9 years STANDARD_DEVIATION 9.5 |
| BMI | 29.5 kg/m2 STANDARD_DEVIATION 7.2 | 30.0 kg/m2 STANDARD_DEVIATION 7.7 | 29.8 kg/m2 STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 55 Participants | 54 Participants | 109 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 54 |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
Primary
NRS (Numerical Rating Scale)
The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.
Time frame: 2-8 hours
Population: Our analysis uses all available data. Some participants were not in house for the full 8 hours of collection, others did not complete NRS at the respective time point. Therefore the number at each time point differs from the overall number of participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Gabapentin | NRS (Numerical Rating Scale) | Hour 2 | 3.5 units on a scale |
| Gabapentin | NRS (Numerical Rating Scale) | Hour 4 | 5.4 units on a scale |
| Gabapentin | NRS (Numerical Rating Scale) | Hour 6 | 5.3 units on a scale |
| Gabapentin | NRS (Numerical Rating Scale) | Hour 8 | 5.7 units on a scale |
| Placebo | NRS (Numerical Rating Scale) | Hour 8 | 5.1 units on a scale |
| Placebo | NRS (Numerical Rating Scale) | Hour 2 | 3.4 units on a scale |
| Placebo | NRS (Numerical Rating Scale) | Hour 6 | 5.8 units on a scale |
| Placebo | NRS (Numerical Rating Scale) | Hour 4 | 5.5 units on a scale |
Comparison: Hour 2 Analysisp-value: 0.8995% CI: [-1.2, 1.3]Mixed Models Analysis
Comparison: Hour 4 Analysisp-value: 0.9495% CI: [-1.6, 1.5]Mixed Models Analysis
Comparison: Hour 6 Analysisp-value: 0.6495% CI: [-2.2, 1.3]Mixed Models Analysis
Comparison: Hour 8 Analysisp-value: 0.5995% CI: [-1.6, 2.8]Mixed Models Analysis
Secondary
Total Morphine Consumption
Time frame: 12 hours post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Total Morphine Consumption | 14.3 mg | Standard Deviation 12.6 |
| Placebo | Total Morphine Consumption | 14.7 mg | Standard Deviation 12.3 |
p-value: 0.88t-test, 2 sided
Secondary
VAS (Visual Analog Scale)
The VAS is scored using a horizontal line 100mm in length. The scale is anchored by no pain (score of 0) and worst pain (score of 100).
Time frame: 2 -6 hours
Population: Our analysis uses all available data. Some participants were not in house for the full 6 hours of collection, others did not complete VAS at the respective time point. Therefore the number at each time point differs from the overall number of participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Gabapentin | VAS (Visual Analog Scale) | Hour 6 | 38.7 units on a scale |
| Gabapentin | VAS (Visual Analog Scale) | Hour 2 | 37.8 units on a scale |
| Placebo | VAS (Visual Analog Scale) | Hour 2 | 33.9 units on a scale |
| Placebo | VAS (Visual Analog Scale) | Hour 6 | 36.9 units on a scale |
Comparison: Hour 2 Analysisp-value: 0.5295% CI: [-8.1, 15.8]Mixed Models Analysis
Comparison: Hour 6 Analysisp-value: 0.895% CI: [-11.9, 15.3]Mixed Models Analysis