NCT03391284

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

January 9, 2016

Last Update Submit

November 18, 2022

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

  • Pain - VAS

    Pain level 2 hours post treatment

    2 hours

Secondary Outcomes (2)

  • Pain - VAS

    4 hours

  • Pain - VAS

    24 hours

Study Arms (2)

Oral Acetominophen Arm

EXPERIMENTAL

1000 mg acetominophen oral

Drug: acetominophenDrug: Acetaminophen

Intravenous

ACTIVE COMPARATOR

1000 mg acetominophen intravenous

Drug: acetominophenDrug: Acetaminophen

Interventions

acetominophenDRUG

INTRAVENOUS

Also known as: Ofirmev
IntravenousOral Acetominophen Arm
AcetaminophenDRUG

ORAL

Also known as: Tylenol
IntravenousOral Acetominophen Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Scripps Clinic

San Diego, California, 92130, United States

Location

Scripps Clininc Dept of Ob/Gyn

San Diego, California, 92130, United States

Location

Related Publications (1)

  • 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.

    PMID: 31764741DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Bruce Kahn, MD

    Scripps

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 9, 2016

First Posted

January 5, 2018

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

US(2)