Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery

NCT ID: NCT04710277

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2022-10-20

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.

Conditions

Postoperative Pain; Narcotic Use; Cryotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Novel multimodal protocol group

They will receive scheduled topical ice therapy for 24 hours after surgery. It will be applied over abdominal incisions for 20 minutes every 2-3 hours. Acetaminophen and an NSAID will be scheduled for 96 hours. While inpatient, they will receive acetaminophen 975 mg every 8 hours and IV Toradol 15-30 mg every 6 hours with change to ibuprofen 800 mg every 8 hours when tolerating oral intake. They may take oxycodone 5 mg every 4-6 hours as needed (PRN) for breakthrough pain and pain score \>6. They may use ice PRN after 24 hours. They will be prescribed acetaminophen 1000 mg every 8 hours and ibuprofen 800 mg every 8 hours for 96 hours postoperative. They may take them as needed after. If the participant used 0 narcotics in the first 24 hours, they will not be prescribed a narcotic. If up to 5 tablets were used, they will be prescribed 5 tablets of oxycodone 5 mg every 6 hours PRN. If more than 5 tablets were used, they will be prescribed 10 tablets of oxycodone 5 mg every 6 hours PRN.

Group Type: EXPERIMENTAL

Opioid-sparing multimodal pain management

Intervention Type: OTHER

Ice pack applied to abdominal incisions for 20 minutes every 2 to 3 hours for 24 hours after surgery and scheduled acetaminophen and NSAID for 96 hours after surgery. Narcotic pain medication for severe breakthrough pain.

Usual care protocol group

Participants randomly assigned to the usual care protocol will receive current standard of care: scheduled acetaminophen and an NSAID for 24 hours. They will take acetaminophen 975 mg every 8 hours. They will also receive IV toradol 15 to 30 mg every 6 hours then switch to ibuprofen 800 mg every 8 hours when tolerating oral intake. They can also take oxycodone 5 mg every 4 to 6 hours on an as needed (PRN) basis for breakthrough pain with a pain score \>6. Per our current standard of care, usual care participants will be allowed to use either topical heat or ice on an as needed basis during their recovery. On discharge home, they will be prescribed acetaminophen 1000 mg every 8 hours PRN and ibuprofen 800 mg every 8 hours PRN. They will also be prescribed 15 tablets of oxycodone 5 mg every 6 hours PRN.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Scheduled acetaminophen and NSAID for 24 hours after surgery. Narcotic pain medication for severe breakthrough pain.

Interventions

Opioid-sparing multimodal pain management

Ice pack applied to abdominal incisions for 20 minutes every 2 to 3 hours for 24 hours after surgery and scheduled acetaminophen and NSAID for 96 hours after surgery. Narcotic pain medication for severe breakthrough pain.

Intervention Type: OTHER

Usual care

Scheduled acetaminophen and NSAID for 24 hours after surgery. Narcotic pain medication for severe breakthrough pain.

Intervention Type: OTHER

Other Intervention Names

Ice therapy; Ice pack; Cryotherapy

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Silpa Nekkanti

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silpa Nekkanti, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2020H0077

Identifier Type: -

Identifier Source: org_study_id