Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2019 |
| Start Date: | August 8, 2018 |
| End Date: | October 1, 2019 |
| Contact: | Kari M Plewniak, MD BS |
| Email: | kmplewniak@gmail.com |
| Phone: | 716-909-6976 |
Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription
Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the
opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing
in the post-operative period. There is wide variation in the prescribing practices for
post-operative pain control and there is no standard of care for pain control after minor
laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to
show that on average half of the opioids prescribed are unused by the patient. The aim of the
study is to evaluate two opioid prescription regimens.
opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing
in the post-operative period. There is wide variation in the prescribing practices for
post-operative pain control and there is no standard of care for pain control after minor
laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to
show that on average half of the opioids prescribed are unused by the patient. The aim of the
study is to evaluate two opioid prescription regimens.
This will be a randomized controlled study enrolling participants scheduled for outpatient
minor laparoscopic gynecologic surgery. This is a two arm study consisting of 60 subjects in
each arm. The participants will be randomized at the time of enrollment. We will use computer
generated blocks of four participants. Both arms of participants will receive the same
non-narcotic pain medication prescriptions which will include fifty tablets of acetaminophen
500mg (1-2 tablets every 6 hours as needed) and twenty-five tablets ibuprofen 600mg (1 tablet
every 6 hours as needed). The arms will only differ in the number of tablets of oxycodone
prescribed. In one arm (experimental) subjects will receive five tablets of Oxcodone 5mg (1
tablet every 6 hours as needed) and the other arm (comparator) ten tablets of Oxycodone 5mg
(1 tablet every 6 hours as needed). Both prescription regimens are within the range of normal
clinical practice for post-operative pain control.
The participants will receive a telephone call by administrative staff, who is not directly
involved in the participants care or data collection for the study subjects, on postoperative
day 1 and 7. The participants will all be scheduled for a 2- week post-operative follow up
with the surgeon in the office. The primary outcome to be assessed will be number of opioids
used by the participants at 24 hours and 7 days post-operative. The primary hypothesis is
that participants prescribed only 5 tabs of oxycodone will not require more medication. The
secondary hypothesis is that the pain scores between the two groups will not be different.
The other variables being studied include the following: having had a post-operative bowel
movement, presence of nausea, number of ibuprofen, acetaminophen tablets remaining, calls to
the office prior to the follow up visit for pain issues, and urgent or emergency department
visits for pain issues. These assessments will be asked during the brief telephone calls and
also at the postoperative visit.
All participants will be given the clinic phone number and advised to call with any questions
or clinical concerns. The participants will be advised if possible to return to a Montefiore
Emergency Department or gynecologic provider in case of an urgent issue prior to the 2 week
postoperative visit, as opposed to an outside facility.
minor laparoscopic gynecologic surgery. This is a two arm study consisting of 60 subjects in
each arm. The participants will be randomized at the time of enrollment. We will use computer
generated blocks of four participants. Both arms of participants will receive the same
non-narcotic pain medication prescriptions which will include fifty tablets of acetaminophen
500mg (1-2 tablets every 6 hours as needed) and twenty-five tablets ibuprofen 600mg (1 tablet
every 6 hours as needed). The arms will only differ in the number of tablets of oxycodone
prescribed. In one arm (experimental) subjects will receive five tablets of Oxcodone 5mg (1
tablet every 6 hours as needed) and the other arm (comparator) ten tablets of Oxycodone 5mg
(1 tablet every 6 hours as needed). Both prescription regimens are within the range of normal
clinical practice for post-operative pain control.
The participants will receive a telephone call by administrative staff, who is not directly
involved in the participants care or data collection for the study subjects, on postoperative
day 1 and 7. The participants will all be scheduled for a 2- week post-operative follow up
with the surgeon in the office. The primary outcome to be assessed will be number of opioids
used by the participants at 24 hours and 7 days post-operative. The primary hypothesis is
that participants prescribed only 5 tabs of oxycodone will not require more medication. The
secondary hypothesis is that the pain scores between the two groups will not be different.
The other variables being studied include the following: having had a post-operative bowel
movement, presence of nausea, number of ibuprofen, acetaminophen tablets remaining, calls to
the office prior to the follow up visit for pain issues, and urgent or emergency department
visits for pain issues. These assessments will be asked during the brief telephone calls and
also at the postoperative visit.
All participants will be given the clinic phone number and advised to call with any questions
or clinical concerns. The participants will be advised if possible to return to a Montefiore
Emergency Department or gynecologic provider in case of an urgent issue prior to the 2 week
postoperative visit, as opposed to an outside facility.
Inclusion Criteria:
- Must be over 18 years of age
- Scheduled for outpatient gynecologic laparoscopy
Exclusion Criteria:
- Significant renal or liver disease is present that would alter prescribing patterns
- Chronic opioid use or abuse
- Allergy to acetaminophen, ibuprofen, other nsaids or narcotic medications
- Conversion of surgery to exploratory laparotomy
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Phone: 718-920-7294
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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