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

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acetominophen
Acetaminophen
Sponsored by
Scripps Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Clinic
  • Scripps Clininc Dept of Ob/Gyn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral Acetominophen Arm

Intravenous

Arm Description

1000 mg acetominophen oral

1000 mg acetominophen intravenous

Outcomes

Primary Outcome Measures

Pain - VAS
Pain level 2 hours post treatment

Secondary Outcome Measures

Pain - VAS
Pain level 4 hours post treatment
Pain - VAS
Pain level 24 hours post treatment

Full Information

First Posted
January 9, 2016
Last Updated
November 18, 2022
Sponsor
Scripps Health
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1. Study Identification

Unique Protocol Identification Number
NCT03391284
Brief Title
Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery
Official Title
Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen Mean 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 - Narcotics, NSAIDs Difference in postoperative N/V between groups Patient rated measure - none, mild, moderate, severe 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: Evaluate N/V - self-rated as none, mild, moderate, severe Document amount of analgesic use (narcotic, NSAIDs) during hospital course Compute cost comparison between medications Demographics to collect: Age, parity, BMI, procedure indication, pathology including uterine weight, procedure length

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Acetominophen Arm
Arm Type
Experimental
Arm Description
1000 mg acetominophen oral
Arm Title
Intravenous
Arm Type
Active Comparator
Arm Description
1000 mg acetominophen intravenous
Intervention Type
Drug
Intervention Name(s)
acetominophen
Other Intervention Name(s)
Ofirmev
Intervention Description
INTRAVENOUS
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
ORAL
Primary Outcome Measure Information:
Title
Pain - VAS
Description
Pain level 2 hours post treatment
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Pain - VAS
Description
Pain level 4 hours post treatment
Time Frame
4 hours
Title
Pain - VAS
Description
Pain level 24 hours post treatment
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Kahn, MD
Organizational Affiliation
Scripps
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Scripps Clininc Dept of Ob/Gyn
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31764741
Citation
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.
Results Reference
derived

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

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