Post Operative Pain
Conditions
Keywords
IV Acetaminophen, Vaginal Reconstruction, Pain, Postoperative
Brief summary
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.
Detailed description
see brief summary
Interventions
DRUGIV Acetaminophen
Details covered in arm description.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Women between the ages of 18 and 70 years * Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio * Scheduled to undergo major vaginal reconstruction * Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.
Exclusion criteria
* Allergy to acetaminophen * Liver disease (chronic or active) * Chronic alcohol use (\>1 drink/day) * Bleeding diathesis * Renal disease * Opiate dependent or daily use * History of chronic pain * Mental or cognitive disorder preventing patient to accurately verbalize pain levels * Undergoing abdominal or laparoscopic procedures at the time of surgery * Allergy to hydromorphone * Surgery is not performed under general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain While Active - 18 hr | 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. |
| Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery | 24 hours | Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Associated Side Effects | 24 hours | The incidence of known narcotic associated side effects will be recorded for nausea/vomiting. |
| Time to First Rescue Narcotic | 24 hours | The time from the end of surgery to the time any IV narcotic is given. |
| Time to Ambulation | 1800 minutes | Length of time from the end of surgery to the time of ambulation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to First Flatus/Bowel Movement | 9000 minutes | Length of time from the end of surgery to the time of first flatus or bowel movement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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. | 43 |
| Total | 90 |
Baseline characteristics
| Characteristic | IV Acetaminophen | Total | Saline |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 12.8 | 58.3 years STANDARD_DEVIATION 12.12 | 59.4 years STANDARD_DEVIATION 11.4 |
| 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 | 0 Participants | 0 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 | 47 Participants | 90 Participants | 43 Participants |
| Region of Enrollment United States | 47 Participants | 90 Participants | 43 Participants |
| Sex: Female, Male Female | 47 Participants | 90 Participants | 43 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 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Pain While Active - 18 hr
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.
Time frame: 18 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Acetaminophen | Pain While Active - 18 hr | 42.0 mm |
| Saline | Pain While Active - 18 hr | 50.0 mm |
Comparison: The comparison was analyzed using the Mann-Whitney U test.p-value: 0.328Wilcoxon (Mann-Whitney)
Primary
Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Acetaminophen | Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery | 13 mgs |
| Saline | Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery | 15 mgs |
Secondary
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for itching.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Narcotic Associated Side Effects | 11 Participants |
| Saline | Narcotic Associated Side Effects | 5 Participants |
Secondary
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for headache.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Narcotic Associated Side Effects | 6 Participants |
| Saline | Narcotic Associated Side Effects | 3 Participants |
Secondary
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for insomnia.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Narcotic Associated Side Effects | 8 Participants |
| Saline | Narcotic Associated Side Effects | 2 Participants |
Secondary
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.
Time frame: 24 hours
Population: Count reported for nausea/vomiting.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Narcotic Associated Side Effects | 27 Participants |
| Saline | Narcotic Associated Side Effects | 22 Participants |
Secondary
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for shortness of breath.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Narcotic Associated Side Effects | 4 Participants |
| Saline | Narcotic Associated Side Effects | 0 Participants |
Secondary
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for respiratory depression.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Narcotic Associated Side Effects | 0 Participants |
| Saline | Narcotic Associated Side Effects | 0 Participants |
Secondary
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for urinary retention.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Narcotic Associated Side Effects | 29 Participants |
| Saline | Narcotic Associated Side Effects | 20 Participants |
Secondary
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for rash/hives.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Narcotic Associated Side Effects | 0 Participants |
| Saline | Narcotic Associated Side Effects | 0 Participants |
Secondary
Time to Ambulation
Length of time from the end of surgery to the time of ambulation.
Time frame: 1800 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Acetaminophen | Time to Ambulation | 1295 minutes |
| Saline | Time to Ambulation | 1252 minutes |
Secondary
Time to First Rescue Narcotic
The time from the end of surgery to the time any IV narcotic is given.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Acetaminophen | Time to First Rescue Narcotic | 27 minutes |
| Saline | Time to First Rescue Narcotic | 41 minutes |
Other Pre-specified
Time to First Flatus/Bowel Movement
Length of time from the end of surgery to the time of first flatus or bowel movement.
Time frame: 9000 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Acetaminophen | Time to First Flatus/Bowel Movement | 3977 minutes |
| Saline | Time to First Flatus/Bowel Movement | 1899 minutes |