Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT03420794
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2018-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of Pre-operative Oral Analgesics in Patients Undergoing Ambulatory Minimally Invasive Hysterectomy
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Optimization of Pre-operative Oral Analgesics in Patients Undergoing Ambulatory Minimally Invasive Hysterectomy
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: