Clinical trial NCT04710277: Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery
Official title: Randomized Controlled Trial of a Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Narcotic Use
Cryotherapy Effect
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned prospectively to one of two interventions according to protocol to evaluate the effect of the intervention on their postoperative pain, quality of recovery, patient satisfaction, and overall analgesic use.
Primary purpose: TREATMENT

Brief summary: The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain control after minimally invasive gynecologic surgery.

Detailed description: The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain control after minimally invasive gynecologic surgery. The study will include women \>/= 18yo who speak English and are admitted for observation after a qualifying laparoscopic or robotic gynecologic procedure. The investigators will identify potential participants from the operating schedule, screen for any exclusion criteria, and approach those eligible for inclusion on the day of surgery. All participants will receive a pain regimen with medications commonly used to manage post-surgical pain including nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and prescription opioids. Participants randomized to the intervention arm will receive prolonged scheduled NSAID and acetaminophen (96 hours instead of 24 hours) and will receive 24 hours of intermittent ice-therapy (20 minutes every 2-3 hours) on their abdominal incisions beginning within 1-2 hours after surgery. On post-operative day or day 1, a study investigator will administer a study questionnaire to all participants which will include a pain score, satisfaction score, and quality of recovery validated survey (the QoR-40). After discharge, participants will complete short web-based survey questionnaires on day 2 and 3. On day 4 a final and more comprehensive web-based survey will be sent to all participants which will include the 24-hour assessment in addition to the QoR-40 questionnaire, a final satisfaction questionnaire, and pill counts of left-over discharge medications. The day 4 survey completes the participants active part in the study. On or after day 30 a chart review will be performed to assess for post-operative complications, emergency room visits, telephone calls, unexpected office visits, and refill requests. An Ohio Rx Reporting System (OARRS) report will further screen for any additional narcotic prescriptions in the 30 day postoperative period. This will mark completion of participation in study. The completion of the study questionnaires is anticipated to take about 1.5 to 2 hours in total time throughout the study. There are no additional clinic visits or costs associated with participation in this study.

Eligibility criteria: Inclusion Criteria:

* Minimally invasive (laparoscopic or robotic) major gynecologic procedures including: pelvic floor procedures (uterosacral ligament suspension, sacrocolpopexy, Burch colposuspension) with or without concomitant hysterectomy, adnexal surgery, or vaginal surgery; total or supracervical hysterectomy with or without concomitant adnexal surgery, vaginal surgery, or other minor gynecologic procedures
* Patients admitted to the hospital for at least an overnight observation after their surgery
* English-speaking
* Surgery being performed by one of the five attending surgeons included in study

Exclusion Criteria:

* Pregnancy. If patient is of childbearing potential and not using contraception a urine pregnancy test will be completed as part of standard practice as part of pre-operative labs.
* Diagnosis of chronic pelvic pain. Documented pelvic pain noted to be of \>6 months duration.
* Diagnosis or history of chronic opioid use. Defined as use of opioids most days, for more than 3 months.
* Diagnosis or history of opioid abuse disorder.
* Current daily opioid use.
* Liver, renal, or cardiac disease that is/are a contraindication to any medications used in the study.
* Allergy or intolerance to any medication used in the study (with exception of oxycodone which can be substituted for hydromorphone if necessary).
* Dementia or inability to understand or respond to the study measurement tools.
* Intraoperative exclusion criteria (to be reviewed after surgery is complete): conversion to total vaginal procedure or laparotomy, major intraoperative complications that would deem participant inappropriate for trial (hemorrhage, blood transfusion, conversion to laparotomy, bowel surgery, major urologic procedures including bladder or ureteral repair).

Primary outcomes:
measure: Day 1 pain score assessed by NRS-11
timeFrame: During the intervention on postoperative day 1 between 0600 to 0900
Secondary outcomes:
measure: Day 2 to 4 pain score assessed by NRS-11
timeFrame: During the intervention on postoperative day 2 to 4
measure: Quality of Recovery assessed by QoR-40
timeFrame: During the intervention on postoperative day 1 and 4
measure: Patient satisfaction with pain control assessed by NRS-11
timeFrame: During the intervention on postoperative day 1 and 4
measure: Patient satisfaction with ice therapy assessed by NRS-11
timeFrame: During the intervention on postoperative day 1 and 4
measure: Patient satisfaction with ice therapy assessed by brief questionnaire
timeFrame: During the intervention on postoperative day 1 and 4
measure: Analgesic use - opioids measured by morphine equivalents
timeFrame: Immediately after the surgery from postoperative day 0 to 4
measure: Analgesic use frequency - acetaminophen
timeFrame: Immediately after the surgery from postoperative day 0 to 4
measure: Analgesic use dosage - acetaminophen measured by milligrams
timeFrame: Immediately after the surgery from postoperative day 0 to 4
measure: Analgesic use frequency - NSAID
timeFrame: Immediately after the surgery from postoperative day 0 to 4
measure: Analgesic use dosage - NSAID measured by milligrams
timeFrame: Immediately after the surgery from postoperative day 0 to 4
measure: Analgesic use - other neuraxial agent
timeFrame: Immediately after the surgery from postoperative day 0 to 4
measure: Ice therapy use frequency
timeFrame: Immediately after the surgery from postoperative day 0 to 4
measure: 30-day postoperative outcomes
timeFrame: After the surgery on postoperative day 1 to 30
measure: Adverse events (AEs)
timeFrame: During the intervention on postoperative day 1 to 4
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Silpa Nekkanti, MD
role: PRINCIPAL_INVESTIGATOR
References: