Gynecologic Cancer, Post-operative Pain
Conditions
Keywords
Pain control, Gynecologic Oncology, Surgery
Brief summary
This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.
Interventions
DRUGBupivicaine
The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis
DRUGPlacebo
The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing robotic-assisted surgery under the care of the Division of Gynecologic Oncology at UWHC. * Patients must be ≥18 years old. * Patients must be English speaking. * Patients must have the ability to understand visual and verbal pain scales. * ASA physical status 1-3.
Exclusion criteria
* Known allergy to local anesthetics. * Immunocompromised. * Known history of opioid dependence, as available within the medical record and standard of care pre-operative work-up. * Known history of chronic pain disorders. * Pregnancy or lactation. * Patient is a prisoner or incarcerated. * Significant liver disease that would inhibit prescription of opioids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | from 2 hours post-op to the afternoon/evening of post-op day #1 | Pain scores by the Visual Analog Scale (VAS) \[0-5, where 0 is no pain and 5 is extreme\] and Wisconsin Brief Pain Inventory (BPI) \[where 0 is no pain and 10 is the most painful\], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score. |
Countries
United States
Participant flow
Pre-assignment details
A total of 75 patients agreed to participate in the study. Eight patients did not meet inclusion criteria for the study, 2 patients were excluded from the analysis secondary to intraoperative conversion to laparotomy, and 1 additional patient was excluded because the robot was unavailable. This left a total of 64 subjects who completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Bupivicaine TAP block with bupivicaine/epinephrine placed prior to surgery.
Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis | 31 |
| Placebo TAP block with placebo placed prior to surgery
Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline. | 33 |
| Total | 64 |
Baseline characteristics
| Characteristic | Bupivicaine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 11.48 | 62.1 years STANDARD_DEVIATION 14.29 | 58.7 years STANDARD_DEVIATION 14.29 |
| Body Mass Index (BMI) | 34.2 kg/m^2 STANDARD_DEVIATION 12.12 | 36.3 kg/m^2 STANDARD_DEVIATION 9.01 | 35.3 kg/m^2 STANDARD_DEVIATION 12.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 29 Participants | 60 Participants |
| Region of Enrollment United States | 31 participants | 33 participants | 64 participants |
| Sex: Female, Male Female | 31 Participants | 33 Participants | 64 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 | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
Primary
24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine | 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents | 64.9 mg | Standard Deviation 28.65 |
| Placebo | 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents | 69.3 mg | Standard Deviation 32.73 |
Secondary
Pain Scores
Pain scores by the Visual Analog Scale (VAS) \[0-5, where 0 is no pain and 5 is extreme\] and Wisconsin Brief Pain Inventory (BPI) \[where 0 is no pain and 10 is the most painful\], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score.
Time frame: from 2 hours post-op to the afternoon/evening of post-op day #1
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bupivicaine | Pain Scores | VAS | 3.12 units on a scale |
| Bupivicaine | Pain Scores | BPI | 6.44 units on a scale |
| Placebo | Pain Scores | VAS | 3.61 units on a scale |
| Placebo | Pain Scores | BPI | 6.97 units on a scale |