Trial Outcomes & Findings for Study of TAP and Laparoscopic and Robotic Gynecologic Procedures and Obese Women (NCT NCT01866917)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

35 participants

Primary outcome timeframe

0, 1, and 2 hours

Results posted on

2020-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Transversus Abdominal Plane Ropivicaine 0.5% 20cc injectate bilaterally Group B	Saline Normal saline 20cc injectate bilaterally Group A
Overall Study STARTED	17	18
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Transversus Abdominal Plane Ropivicaine 0.5% 20cc injectate bilaterally Group B	Saline Normal saline 20cc injectate bilaterally Group A
Overall Study Pharmacist stopped dispensing treatment	4	6

Baseline Characteristics

Study of TAP and Laparoscopic and Robotic Gynecologic Procedures and Obese Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transversus Abdominal Plane (Drug B) n=13 Participants Ropivicaine 0.5% 20cc injectate bilaterally	Saline (Drug A) n=12 Participants Normal saline 20cc injectate bilaterally	Total n=25 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 7.97 • n=5 Participants	42.0 years STANDARD_DEVIATION 7.97 • n=7 Participants	43.8 years STANDARD_DEVIATION 7.97 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	Transversus Abdominis Plane (TAP) Group B n=13 Participants Ropivicaine 0.5% 20cc IV bilaterally	Saline Group A n=12 Participants Normal saline 20cc IV bilaterally
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 Interval 0.0 to 8.0	5.5 score on a scale Interval 0.0 to 9.0
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 Interval 0.0 to 8.0	3.5 score on a scale Interval 0.0 to 5.0
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 Interval 0.0 to 6.0	4.5 score on a scale Interval 0.0 to 5.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Transversus Abdominis Plane (TAP) Group B n=13 Participants Ropivicaine 0.5% 20cc IV bilaterally	Saline Group A n=12 Participants Normal saline 20cc IV bilaterally
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 Interval 0.0 to 7.0	5.5 score on a scale Interval 0.0 to 6.0
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 Interval 0.0 to 5.0	2 score on a scale Interval 0.0 to 6.0
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 Interval 0.0 to 6.0	3 score on a scale Interval 0.0 to 5.0
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 Interval 0.0 to 6.0	1.5 score on a scale Interval 0.0 to 7.0

Adverse Events

Group B (TAP Block)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group A (Saline)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ja Hyun Shin

Montefiore Medical Center

Phone: 718-920-5157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place