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

NCT ID: NCT02043704

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-08-31

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

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

IV Acetaminophen

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

IV Acetaminophen

Intervention Type: DRUG

Details covered in arm description.

Interventions

IV Acetaminophen

Details covered in arm description.

Intervention Type: DRUG

Other Intervention Names

Ofirmev

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catrina Crisp, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

TriHealth - Good Samaritan and Bethesda North Hospitals

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28230615 (View on PubMed)

Other Identifiers

13072

Identifier Type: -

Identifier Source: org_study_id