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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043704
• Other study ID #: 13072
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2018
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• IV Acetaminophen
Details covered in arm description.

Locations

Country	Name	City	State
United States	TriHealth - Good Samaritan and Bethesda North Hospitals	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

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