Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management

NCT03129464 | Completed Results DMC FDA Device

• 1 other identifier: FLA 16-111
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. After surgery is completed participants will be randomized to either the control group or the study group. The study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. The cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. Investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores. This study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. Secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. Investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain Score

  Post-operative pain score on an 11 point numeric rating scale, minimum value of 0 and maximum value of 10, zero meaning no pain and 10 meaning the worst pain imaginable.

  24 hours post-operatively following total laparoscopic hysterectomy

Secondary Outcomes (4)

• Post-operative Pain Score

  72 hours post-operatively following total laparoscopic hysterectomy

• Patient Reported Quantity of Narcotics Used Post-operatively

  72 hours post-operatively following total laparoscopic hysterectomy

• Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale

  72 hours post-operatively following total laparoscopic hysterectomy

• Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale

  10-14 days post-operatively following total laparoscopic hysterectomy

Other Outcomes (1)

• Total Amount of Narcotics Used Post-operatively

  10-14 days postoperatively following total laparoscopic hysterectomy

Study Arms (2)

Cold Therapy

EXPERIMENTAL

Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. Intervention will include the patient being asked to use a reusable cold gel pack to deliver cold therapy to their abdominal incisions every 6 hours for the first 72 hours.

Device: Cold therapy via reusable cold gel pack

Control

NO INTERVENTION

Patients undergoing total laparoscopic hysterectomy will receive routine pre-operative multi-modal analgesia regimen and well as routine post-operative analgesia with instructions for dosing. They will not receive any additional intervention.

Interventions

Cold therapy via reusable cold gel pack DEVICE

Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.

Cold Therapy

Eligibility Criteria

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

You may qualify if:

• Patients can understand and voluntarily sign an informed consent form
• Female gender ages 18-65
• Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy)

You may not qualify if:

• Conversion to laparotomy
• Diagnosis of chronic pelvic pain
• No access to freezer at home to keep reusable cold packs cold between uses
• Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum)
• Medical contraindication to NSAID use

Sponsors & Collaborators

• Cleveland Clinic Florida: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pamela Frazzini Padilla
• Organization: Cleveland Clinic Florida

frazzip@ccf.org

9546595559f

Study Officials

• Michael L Sprague, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 26, 2017
• Study Start: February 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 18, 2024
• Results First Posted: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)