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



Status:Enrolling by invitation
Conditions:Post-Surgical Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:18 - Any
Updated:1/7/2018
Start Date:February 2016
End Date:February 2018

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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

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

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.
We found this trial at
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San Diego, California 92037
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3811 Valley Centre Drive
San Diego, California 92130
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