Optimization of Pre-operative Oral Analgesics in Patients Undergoing Ambulatory Minimally Invasive Hysterectomy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | January 12, 2018 |
| End Date: | June 30, 2019 |
This is a randomized controlled trial comparing pre-admission administration of routine oral
preoperative non-narcotic analgesics with the administration of these medications in the
pre-anesthesia care unit per our standard practice. Patients will be screened, enrolled,
consented, and randomized during the preoperative office encounter, typically occurring
within the 30 days prior to surgery. Patients randomized to pre-admission administration
(study group) will be provided with a prescription for a one-time dosing of routine oral
non-narcotic analgesic medications to be filled at the Cleveland Clinic outpatient pharmacy.
Both the study and the control groups will receive written pre-operative instructions. Those
patients randomized to the standard practice of administration in the pre-anesthesia unit
(control group) will be administered the same medications in the same doses by the nursing
staff.
Patients in both groups will undergo general anesthesia, orogastric tube placement, and
minimally invasive hysterectomy (MIH). Post-operatively, patient pain will be assessed via
NRS at standard intervals and treated with narcotics. Amount of total intravenous (IV) and
oral (PO) narcotics given during PACU stay will be documented in the medication
administration record (MAR) within the electronic medical record (EMR) and later converted
into oral morphine equivalents (OME). Pain will be assessed via NRS on discharge and
documented.
Patients will be emailed on POD10 a survey to rate their satisfaction with their medication
administration regimen on a 5-point Likert scale. Participants will also be asked to complete
a thirteen-point surgical recovery scale (SRS) to evaluate their functional recovery from
MIH.
Patient participation will conclude after completion of the patient satisfaction survey and
SRS. A maximum of 58 patients will be enrolled into the study, as we aim to randomize 26
patients to each arm.
preoperative non-narcotic analgesics with the administration of these medications in the
pre-anesthesia care unit per our standard practice. Patients will be screened, enrolled,
consented, and randomized during the preoperative office encounter, typically occurring
within the 30 days prior to surgery. Patients randomized to pre-admission administration
(study group) will be provided with a prescription for a one-time dosing of routine oral
non-narcotic analgesic medications to be filled at the Cleveland Clinic outpatient pharmacy.
Both the study and the control groups will receive written pre-operative instructions. Those
patients randomized to the standard practice of administration in the pre-anesthesia unit
(control group) will be administered the same medications in the same doses by the nursing
staff.
Patients in both groups will undergo general anesthesia, orogastric tube placement, and
minimally invasive hysterectomy (MIH). Post-operatively, patient pain will be assessed via
NRS at standard intervals and treated with narcotics. Amount of total intravenous (IV) and
oral (PO) narcotics given during PACU stay will be documented in the medication
administration record (MAR) within the electronic medical record (EMR) and later converted
into oral morphine equivalents (OME). Pain will be assessed via NRS on discharge and
documented.
Patients will be emailed on POD10 a survey to rate their satisfaction with their medication
administration regimen on a 5-point Likert scale. Participants will also be asked to complete
a thirteen-point surgical recovery scale (SRS) to evaluate their functional recovery from
MIH.
Patient participation will conclude after completion of the patient satisfaction survey and
SRS. A maximum of 58 patients will be enrolled into the study, as we aim to randomize 26
patients to each arm.
Inclusion Criteria:
1. Subject must be women, at least 18 years of age
2. Subjects must be undergoing minimally invasive hysterectomy for benign indications
3. Subjects must be capable of giving informed consent
4. Subjects must be English-language speaking. This is required as the validated surgical
recovery surveys utilized in this protocol have not been validated in any language
other than English.
Exclusion Criteria:
1. Subjects may not have a history of chronic pain
2. Subjects may not have a history of chronic use of pain medication
3. Subjects may not have an allergy or medical contraindication to the preoperative
non-narcotic analgesics or to opioid pain medication
4. Subjects must not have been previously diagnosed with gastroparesis, impaired gastric
emptying, personal history of gastric bypass, or any neuromuscular degenerative
disease. Subjects previously diagnosed with gastro-esophageal reflux are permitted.
We found this trial at
1
site
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
Weston, Florida 33331
866.293.7866
Phone: 954-659-5219
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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