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

TriHealth

Status and phase: Completed; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: IV Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02043704

13072

Details and patient eligibility

About

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.

Full description

see brief summary

Enrollment: 100 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

IV Acetaminophen

Experimental group

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.

Treatment:

Drug: IV Acetaminophen

Saline

Placebo Comparator group

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.

Treatment:

Drug: IV Acetaminophen