Trial Outcomes & Findings for RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain (NCT NCT02043704)

NCT ID: NCT02043704

Last Updated: 2018-08-16

Results Overview

Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 18 hours
• Results posted on: 2018-08-16

Participant Flow

Participant milestones

Measure	IV Acetaminophen Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Overall Study STARTED	50	50
Overall Study COMPLETED	47	43
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain

Baseline characteristics by cohort

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Total n=90 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 12.8 • n=5 Participants	59.4 years STANDARD_DEVIATION 11.4 • n=7 Participants	58.3 years STANDARD_DEVIATION 12.12 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 hours

Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Pain While Active - 18 hr	42.0 mm Interval 27.5 to 61.0	50.0 mm Interval 28.5 to 71.5

PRIMARY outcome

Timeframe: 24 hours

Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery	13 mgs Interval 6.67 to 26.68	15 mgs Interval 5.0 to 26.67

SECONDARY outcome

Timeframe: 24 hours

Population: Count reported for nausea/vomiting.

The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Narcotic Associated Side Effects	27 Participants	22 Participants

SECONDARY outcome

Timeframe: 24 hours

The time from the end of surgery to the time any IV narcotic is given.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Time to First Rescue Narcotic	27 minutes Interval 18.0 to 64.0	41 minutes Interval 22.0 to 67.0

SECONDARY outcome

Timeframe: 24 hours

The incidence of known narcotic associated side effects will be recorded for itching.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Narcotic Associated Side Effects	11 Participants	5 Participants

SECONDARY outcome

Timeframe: 24 hours

The incidence of known narcotic associated side effects will be recorded for headache.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Narcotic Associated Side Effects	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 24 hours

The incidence of known narcotic associated side effects will be recorded for insomnia.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Narcotic Associated Side Effects	8 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 hours

The incidence of known narcotic associated side effects will be recorded for rash/hives.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Narcotic Associated Side Effects	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours

The incidence of known narcotic associated side effects will be recorded for shortness of breath.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Narcotic Associated Side Effects	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours

The incidence of known narcotic associated side effects will be recorded for respiratory depression.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Narcotic Associated Side Effects	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours

The incidence of known narcotic associated side effects will be recorded for urinary retention.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Narcotic Associated Side Effects	29 Participants	20 Participants

SECONDARY outcome

Timeframe: 1800 minutes

Length of time from the end of surgery to the time of ambulation.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Time to Ambulation	1295 minutes Interval 1108.0 to 1462.0	1252 minutes Interval 778.0 to 1459.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 9000 minutes

Length of time from the end of surgery to the time of first flatus or bowel movement.

Outcome measures

Measure	IV Acetaminophen n=47 Participants Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.	Saline n=43 Participants Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description.
Time to First Flatus/Bowel Movement	3977 minutes Interval 1437.0 to 5564.0	1899 minutes Interval 1275.0 to 4580.0

Adverse Events

IV Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Clinical Research Specialist

TriHealth

Phone: 513-862-2341

Email: ganga_devaiah@trihealth.com

Results disclosure agreements

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