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

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ClinicalTrials.gov Identifier: NCT03391284
Recruitment Status : Unknown
Verified December 2017 by Bruce Kahn, Scripps Health.
Recruitment status was:  Enrolling by invitation
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Kahn, Scripps Health

Tracking Information
First Submitted Date  ICMJE January 9, 2016
First Posted Date  ICMJE January 5, 2018
Last Update Posted Date January 5, 2018
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
Pain - VAS [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
  • Pain - VAS [ Time Frame: 4 hours ]
  • Pain - VAS [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery
Official Title  ICMJE Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Pain
Intervention  ICMJE
  • Drug: acetominophen
    INTRAVENOUS
    Other Name: Ofirmev
  • Drug: Acetaminophen
    ORAL
    Other Name: Tylenol
Study Arms  ICMJE
  • Experimental: Oral
    1000 mg acetominophen oral
    Interventions:
    • Drug: acetominophen
    • Drug: Acetaminophen
  • Active Comparator: Intravenous
    1000 mg acetominophen intravenous
    Interventions:
    • Drug: acetominophen
    • Drug: Acetaminophen
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 29, 2017)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03391284
Other Study ID Numbers  ICMJE SCRIPPS-WHR-ACET-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruce Kahn, Scripps Health
Study Sponsor  ICMJE Scripps Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce Kahn, MD Scripps
PRS Account Scripps Health
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP