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

The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: IV Acetaminophen

Detailed Description

see brief summary

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • TriHealth - Good Samaritan and Bethesda North Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: IV Acetaminophen; Details covered in arm description.; Other Names: Ofirmev
Placebo Comparator: 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.	Drug: IV Acetaminophen; Details covered in arm description.; Other Names: Ofirmev

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 hours
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic Associated Side Effects	The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.	24 hours
Time to First Rescue Narcotic	The time from the end of surgery to the time any IV narcotic is given.	24 hours
Narcotic Associated Side Effects	The incidence of known narcotic associated side effects will be recorded for itching.	24 hours
Narcotic Associated Side Effects	The incidence of known narcotic associated side effects will be recorded for headache.	24 hours
Narcotic Associated Side Effects	The incidence of known narcotic associated side effects will be recorded for insomnia.	24 hours
Narcotic Associated Side Effects	The incidence of known narcotic associated side effects will be recorded for rash/hives.	24 hours
Narcotic Associated Side Effects	The incidence of known narcotic associated side effects will be recorded for shortness of breath.	24 hours
Narcotic Associated Side Effects	The incidence of known narcotic associated side effects will be recorded for respiratory depression.	24 hours
Narcotic Associated Side Effects	The incidence of known narcotic associated side effects will be recorded for urinary retention.	24 hours
Time to Ambulation	Length of time from the end of surgery to the time of ambulation.	1800 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Flatus/Bowel Movement	Length of time from the end of surgery to the time of first flatus or bowel movement.	9000 minutes

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Pain, Postoperative; IV Acetaminophen; Vaginal Reconstruction
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 13072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No