Optimization of Pre-operative Oral Analgesics in Patients Undergoing Ambulatory Minimally Invasive Hysterectomy

NCT03420794 | Completed

• 1 other identifier: FLA17-099
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy; Laparoscopy; Analgesia

Outcome Measures

Primary Outcomes (1)

• Immediate post-operative opioid requirement

  To determine the immediate post-operative opioid requirement

  On the date of surgery from the time surgery was completed to the time the patient is discharged from the post-anesthesia care unit, up to 24 hours

Secondary Outcomes (1)

• Patient Satisfaction

  10-14 days after surgery

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients undergoing total laparoscopic hysterectomy for benign disease who will receive celecoxib 200mg, acetaminophen 1000mg, and gabapentin 600mg by mouth once just prior to surgery.

Other: Timing of pre-operative oral non-narcotic analgesics in relation to minimally invasive hysterectomy

Study Group

EXPERIMENTAL

Patients undergoing total laparoscopic hysterectomy for benign disease who will receive celecoxib 200mg, acetaminophen 1000mg, and gabapentin 600mg by mouth once 3-4 hours prior to surgery.

Other: Timing of pre-operative oral non-narcotic analgesics in relation to minimally invasive hysterectomy

Interventions

Timing of pre-operative oral non-narcotic analgesics in relation to minimally invasive hysterectomy OTHER

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). Postoperatively, these patients will be observed for differences in PACU narcotic uptake, pain scores, patient satisfaction, and surgical recovery.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be women, at least 18 years of age
• Subjects must be undergoing minimally invasive hysterectomy for benign indications
• Subjects must be capable of giving informed consent
• 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.

You may not qualify if:

• Subjects may not have a history of chronic pain
• Subjects may not have a history of chronic use of pain medication
• Subjects may not have an allergy or medical contraindication to the preoperative non-narcotic analgesics or to opioid pain medication
• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 5, 2018
• Study Start: January 12, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)