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Trial Outcomes & Findings for Marcaine Use in Laparoscopic Gynecological Surgery (NCT NCT01861665)

NCT ID: NCT01861665

Last Updated: 2018-10-12

Results Overview

Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Post surgery day 0, post surgery day 1, post surgery day 2

Results posted on

2018-10-12

Participant Flow

Participant milestones

Participant milestones
Measure
Medication Pre Incision Left Med Post Incision Right
Subjects acted as their own control with the left side being injected with the medication pre incision and the right side being injected with medication post incision.
Medication Pre Incision Right Med Post Incision Left
Subjects acted as their own control with right side being injected with the medication pre incision and left side being injected with the medication post incision.
Overall Study
STARTED
10
17
Overall Study
COMPLETED
10
17
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Medication Pre Incision Left Med Post Incision Right
n=10 Participants
Participants acted as their own control with left side being injected with medication pre incision and right side being injected with medication post incision.
Medication Pre Incision Right Med Post Incision Left
n=17 Participants
Participants acted as their own control with right side being injected with medication pre incision and left side being injected with medication post incision.
Total
n=27 Participants
Total of all reporting groups
Age, Continuous
33.6 years
STANDARD_DEVIATION 5.79 • n=10 Participants
30.92 years
STANDARD_DEVIATION 3.87 • n=17 Participants
32.26 years
STANDARD_DEVIATION 4.83 • n=27 Participants
Sex: Female, Male
Female
10 Participants
n=10 Participants
17 Participants
n=17 Participants
27 Participants
n=27 Participants
Sex: Female, Male
Male
0 Participants
n=10 Participants
0 Participants
n=17 Participants
0 Participants
n=27 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
10 participants
n=10 Participants
17 participants
n=17 Participants
27 participants
n=27 Participants
Age, Categorical
<=18 years
0 Participants
n=10 Participants
0 Participants
n=17 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=10 Participants
17 Participants
n=17 Participants
27 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=10 Participants
0 Participants
n=17 Participants
0 Participants
n=27 Participants

PRIMARY outcome

Timeframe: Post surgery day 0, post surgery day 1, post surgery day 2

Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.

Outcome measures

Outcome measures
Measure
Marcaine Administered Pre-incision
n=27 Participants
Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision. Marcaine- 0.25%: Marcaine 0.25% administered pre-incision.
Marcaine Administered Post Incision
n=27 Participants
Post-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc post incision. Marcaine- 0.25%: Marcaine 0.25% administered post-incision.
Wong-Baker Faces Pain Rating Scale
Post Op day 0
1.675 units on a scale
Standard Deviation 1.39
1.6 units on a scale
Standard Deviation 1.42
Wong-Baker Faces Pain Rating Scale
Post Op day 1
2 units on a scale
Standard Deviation 0.97
1.85 units on a scale
Standard Deviation 1.45
Wong-Baker Faces Pain Rating Scale
Post Op day 2
1 units on a scale
Standard Deviation 1.6
0.75 units on a scale
Standard Deviation 0.65

Adverse Events

Marcaine Administered Pre-incision.

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Marcaine Administered Post-incision

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

Dr. Glenn Schattman, Associate Professor

Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine.

Phone: 646-962-3836

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place