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

NCT ID: NCT03129464

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-07-01

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

Study Design

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

Study Groups

Cold Therapy

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.

Group Type: EXPERIMENTAL

Cold therapy via reusable cold gel pack

Intervention Type: 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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cold therapy via reusable cold gel pack

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients can understand and voluntarily sign an informed consent form

2. Female gender ages 18-65

3. Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy)

Exclusion Criteria

1. Conversion to laparotomy

2. Diagnosis of chronic pelvic pain

3. No access to freezer at home to keep reusable cold packs cold between uses

4. Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, Raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum)

5. Medical contraindication to NSAID use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cleveland Clinic Florida

OTHER

Sponsor Role: lead

Responsible Party

Pamela Frazzini Padilla

Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael L Sprague, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FLA 16-111

Identifier Type: -

Identifier Source: org_study_id