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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain focused on measuring IV Acetaminophen, Vaginal Reconstruction, Pain, Postoperative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • TriHealth - Good Samaritan and Bethesda North Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV Acetaminophen

Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.
Time to First Rescue Narcotic
The time from the end of surgery to the time any IV narcotic is given.
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for itching.
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for headache.
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for insomnia.
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for rash/hives.
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for shortness of breath.
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for respiratory depression.
Narcotic Associated Side Effects
The incidence of known narcotic associated side effects will be recorded for urinary retention.
Time to Ambulation
Length of time from the end of surgery to the time of ambulation.

Full Information

First Posted
January 21, 2014
Last Updated
July 19, 2018
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02043704
Brief Title
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
Official Title
The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
IV Acetaminophen, Vaginal Reconstruction, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Acetaminophen
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Description
Details covered in arm description.
Primary Outcome Measure Information:
Title
Pain While Active - 18 hr
Description
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
Title
Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
Description
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
Secondary Outcome Measure Information:
Title
Narcotic Associated Side Effects
Description
The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.
Time Frame
24 hours
Title
Time to First Rescue Narcotic
Description
The time from the end of surgery to the time any IV narcotic is given.
Time Frame
24 hours
Title
Narcotic Associated Side Effects
Description
The incidence of known narcotic associated side effects will be recorded for itching.
Time Frame
24 hours
Title
Narcotic Associated Side Effects
Description
The incidence of known narcotic associated side effects will be recorded for headache.
Time Frame
24 hours
Title
Narcotic Associated Side Effects
Description
The incidence of known narcotic associated side effects will be recorded for insomnia.
Time Frame
24 hours
Title
Narcotic Associated Side Effects
Description
The incidence of known narcotic associated side effects will be recorded for rash/hives.
Time Frame
24 hours
Title
Narcotic Associated Side Effects
Description
The incidence of known narcotic associated side effects will be recorded for shortness of breath.
Time Frame
24 hours
Title
Narcotic Associated Side Effects
Description
The incidence of known narcotic associated side effects will be recorded for respiratory depression.
Time Frame
24 hours
Title
Narcotic Associated Side Effects
Description
The incidence of known narcotic associated side effects will be recorded for urinary retention.
Time Frame
24 hours
Title
Time to Ambulation
Description
Length of time from the end of surgery to the time of ambulation.
Time Frame
1800 minutes
Other Pre-specified Outcome Measures:
Title
Time to First Flatus/Bowel Movement
Description
Length of time from the end of surgery to the time of first flatus or bowel movement.
Time Frame
9000 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catrina Crisp, MD, MSc
Organizational Affiliation
TriHealth Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
TriHealth - Good Samaritan and Bethesda North Hospitals
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28230615
Citation
Crisp CC, Khan M, Lambers DL, Westermann LB, Mazloomdoost DM, Yeung JJ, Kleeman SD, Pauls RN. The Effect of Intravenous Acetaminophen on Postoperative Pain and Narcotic Consumption After Vaginal Reconstructive Surgery: A Double-Blind Randomized Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):80-85. doi: 10.1097/SPV.0000000000000347.
Results Reference
derived

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

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