Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery

Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial

Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.

Primary outcome:

• Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen

o Mean Visual analog Scale (VAS) scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).

Secondary outcomes:

• Difference in postoperative analgesic use between groups

  o Narcotics, NSAIDs

• Difference in postoperative N/V between groups

  o Patient rated measure - none, mild, moderate, severe

• Cost comparison between drugs

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: acetominophen; Drug: Acetaminophen

Detailed Description

Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.

Importance/significance: Adequate control of postoperative pain is important for patient satisfaction, adequate healing, and optimizing length of stay. The idea of preemptive analgesia (giving an analgesic prior to first skin incision to prevent sensitization of nerve pathways from the trauma of surgery) has been shown in many studies to improve postoperative pain. Intravenous acetaminophen has been found to be an effective agent when given preemptively, and many surgeons have adopted this practice. Unfortunately, the IV formulation of acetaminophen, unlike the oral formulation, is expensive as it is a relatively new drug. There are other oral analgesics (i.e. Celebrex) that have been found to be efficacious for postoperative pain control when given preemptively. There are no studies in gynecologic surgery, however, comparing the effectiveness of PO acetaminophen with IV acetaminophen. Given that PO acetaminophen is significantly cheaper than the IV formulation, this could result in cost savings for hospital systems while maintaining adequate patient comfort and satisfaction.

Primary outcome:

1. Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen
2. Mean VAS scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).

Secondary outcomes:

1. Difference in postoperative analgesic use between groups - Narcotics, NSAIDs
2. Difference in postoperative N/V between groups
3. Patient rated measure - none, mild, moderate, severe
4. Cost comparison between drugs

Methods:

Patients scheduled to undergo minimally invasive benign gynecologic surgery will be randomized to one of two groups:

Group 1: acetaminophen 1 gram PO 30min before surgery, then saline placebo IV after anesthesia induction but before skin incision

Group 2: receives placebo pill PO 30min before surgery, then acetaminophen 1 gram IV after anesthesia induction but before skin incision

Primary outcome: After surgery, postoperative pain measured at various time points by blinded investigator

2 hours postop, 4 hours postop, 24 hours postop

Secondary outcomes:

1. Evaluate N/V - self-rated as none, mild, moderate, severe
2. Document amount of analgesic use (narcotic, NSAIDs) during hospital course
3. Compute cost comparison between medications

Demographics to collect:

Age, parity, BMI, procedure indication, pathology including uterine weight, procedure length

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92130
      • Scripps Clinic
    • San Diego, California, United States, 92130
      • Scripps Clininc Dept of Ob/Gyn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients 18 years of age or older scheduled to undergo robotic-assisted laparoscopic hysterectomy for benign conditions.

Exclusion Criteria:

• Known or suspected malignancy,
• Active liver/renal disease,
• Chronic alcohol use/alcoholism,
• Allergy to acetaminophen,
• Conversion to laparotomy,
• hx gastroparesis,
• Poorly controlled insulin dependent diabetes or gastric bypass surgery,
• Regular/recent (past 6 months) narcotic use,
• Inability to swallow pills.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oral Acetominophen Arm; 1000 mg acetominophen oral	Drug: acetominophen; INTRAVENOUS; Other Names: Ofirmev; Drug: Acetaminophen; ORAL; Other Names: Tylenol
ACTIVE_COMPARATOR: Intravenous; 1000 mg acetominophen intravenous	Drug: acetominophen; INTRAVENOUS; Other Names: Ofirmev; Drug: Acetaminophen; ORAL; Other Names: Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain - VAS	Pain level 2 hours post treatment	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain - VAS	Pain level 4 hours post treatment	4 hours
Pain - VAS	Pain level 24 hours post treatment	24 hours

Collaborators and Investigators

• Sponsor: Scripps Health
• Investigators: Principal Investigator: Bruce Kahn, MD, Scripps

Publications and helpful links

General Publications

• Lombardi TM, Kahn BS, Tsai LJ, Waalen JM, Wachi N. Preemptive Oral Compared With Intravenous Acetaminophen for Postoperative Pain After Robotic-Assisted Laparoscopic Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1293-1297. doi: 10.1097/AOG.0000000000003578.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: January 9, 2016
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (ACTUAL): January 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• 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: SCRIPPS-WHR-ACET-01