Pain
Conditions
Keywords
Transversis Abdominis Plane Block, obese, robotic surgery, laparoscopic surgery
Brief summary
Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.
Interventions
DRUGRopivacaine 0.5% 20cc injectate bilaterally
DRUGPlacebo
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* BMI greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures
Exclusion criteria
* Conversions, non-obese women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 0, 1, and 2 hours | Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable |
| Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 4hrs, 8hrs, 12hrs, and 24hrs. | Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transversus Abdominal Plane (Drug B) Ropivicaine 0.5% 20cc injectate bilaterally | 13 |
| Saline (Drug A) Normal saline 20cc injectate bilaterally | 12 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Pharmacist stopped dispensing treatment | 4 | 6 |
Baseline characteristics
| Characteristic | Transversus Abdominal Plane (Drug B) | Saline (Drug A) | Total |
|---|---|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 7.97 | 42.0 years STANDARD_DEVIATION 7.97 | 43.8 years STANDARD_DEVIATION 7.97 |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 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 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable
Time frame: 0, 1, and 2 hours
Population: There were 13 participants receiving the Transversus Abdominis Plane TAP (Group B) and 12 participants receiving the placebo Saline (Group A).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transversus Abdominis Plane (TAP) Group B | Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 0 hour | 0 score on a scale |
| Transversus Abdominis Plane (TAP) Group B | Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 1 hour | 3 score on a scale |
| Transversus Abdominis Plane (TAP) Group B | Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 2 hours | 3 score on a scale |
| Saline Group A | Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 0 hour | 5.5 score on a scale |
| Saline Group A | Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 1 hour | 3.5 score on a scale |
| Saline Group A | Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 2 hours | 4.5 score on a scale |
p-value: 0.574Chi-squared
Primary
Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable)
Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable
Time frame: 4hrs, 8hrs, 12hrs, and 24hrs.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transversus Abdominis Plane (TAP) Group B | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 4 hours | 0 score on a scale |
| Transversus Abdominis Plane (TAP) Group B | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 8 hours | 1 score on a scale |
| Transversus Abdominis Plane (TAP) Group B | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 12 hours | 2 score on a scale |
| Transversus Abdominis Plane (TAP) Group B | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 24 hours | 3 score on a scale |
| Saline Group A | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 24 hours | 1.5 score on a scale |
| Saline Group A | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 4 hours | 5.5 score on a scale |
| Saline Group A | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 8 hours | 2 score on a scale |
| Saline Group A | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | 12 hours | 3 score on a scale |
Comparison: TAP has been demonstrated to have a potential role in reducing pain, post-operative opioid requirement, and time to hospital discharge after abdominal hysterectomies and cesarean sections.p-value: 0.825Chi-squared