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

NCT ID: NCT03391284

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-02-28

Brief Summary

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

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

Conditions

Post-operative Pain

Study Design

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

Study Groups

Oral Acetominophen Arm

1000 mg acetominophen oral

Group Type: EXPERIMENTAL

acetominophen

Intervention Type: DRUG

INTRAVENOUS

Acetaminophen

Intervention Type: DRUG

ORAL

Intravenous

1000 mg acetominophen intravenous

Group Type: ACTIVE_COMPARATOR

acetominophen

Intervention Type: DRUG

INTRAVENOUS

Acetaminophen

Intervention Type: DRUG

ORAL

Interventions

acetominophen

INTRAVENOUS

Intervention Type: DRUG

Acetaminophen

ORAL

Intervention Type: DRUG

Other Intervention Names

Ofirmev; Tylenol

Eligibility Criteria

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.

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

Sponsors

Scripps Health

OTHER

Sponsor Role: lead

Responsible Party

Bruce Kahn

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Kahn, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps

Locations

Scripps Clinic

San Diego, California, United States

Scripps Clininc Dept of Ob/Gyn

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31764741 (View on PubMed)

Other Identifiers

SCRIPPS-WHR-ACET-01

Identifier Type: -

Identifier Source: org_study_id