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

Not Applicable

Completed

Conditions: Pain, Postoperative

Interventions: Device: Cold therapy via reusable cold gel pack

Registration Number: NCT03129464

Lead Sponsor: Cleveland Clinic Florida

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 56

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold Therapy	Cold therapy via reusable cold gel pack	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.

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Score	24 hours post-operatively following total laparoscopic hysterectomy	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative Pain Score	72 hours post-operatively following total laparoscopic hysterectomy	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.
Patient Reported Quantity of Narcotics Used Post-operatively	72 hours post-operatively following total laparoscopic hysterectomy	Patient reported quantity of narcotics used post-operatively measured in number of reported 5 mg oxycodone tabs consumed
Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale	72 hours post-operatively following total laparoscopic hysterectomy	Quality of life score as measured by the validated Abdominal Surgery Impact Scale, minimum value is 18, maximum value is 126, with lower values indicating a worse quality of life and higher scores indicating a better quality of life.
Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale	10-14 days post-operatively following total laparoscopic hysterectomy	Functional surgical recovery following major surgery as measured by the validated Surgical Recovery Scale, possible scores range from 0 to 60, with higher scores indicating a better recovery