Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery

NCT04710277 | Completed

• 1 other identifier: 2020H0077
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Narcotic Use; Cryotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Day 1 pain score assessed by NRS-11

  Postoperative day 1 or Day 1 pain score will be measured using a commonly used and validated 11-point numerical rating scale (NRS-11) for pain intensity the morning after surgery between 0600 to 0900. The patient will be prompted to evaluate their current pain at rest. A score of zero will correspond with "no pain" and a score of 10 corresponds with "worst possible pain." The outcome will be recorded directly into their Day 1 study survey in REDCap.

  During the intervention on postoperative day 1 between 0600 to 0900

Secondary Outcomes (14)

• Day 2 to 4 pain score assessed by NRS-11

  During the intervention on postoperative day 2 to 4

• Quality of Recovery assessed by QoR-40

  During the intervention on postoperative day 1 and 4

• Patient satisfaction with pain control assessed by NRS-11

  During the intervention on postoperative day 1 and 4

• Patient satisfaction with ice therapy assessed by NRS-11

  During the intervention on postoperative day 1 and 4

• Patient satisfaction with ice therapy assessed by brief questionnaire

  During the intervention on postoperative day 1 and 4

Study Arms (2)

Novel multimodal protocol group

EXPERIMENTAL

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.

Other: Opioid-sparing multimodal pain management

Usual care protocol group

ACTIVE COMPARATOR

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.

Other: Usual care

Interventions

Opioid-sparing multimodal pain management 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.

Also known as: Ice therapy, Ice pack, Cryotherapy

Novel multimodal protocol group

Usual care OTHER

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

Usual care protocol group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ice; Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health; Therapeutics

Study Officials

• Silpa Nekkanti, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

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: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 14, 2021
• Study Start: April 19, 2021
• Primary Completion: September 20, 2022
• Study Completion: October 20, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)