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

Study Overview
=================
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.

Official Title
-----------------
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management in Women Undergoing Laparoscopic Hysterectomy

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Device: Cold therapy via reusable cold gel pack


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold Therapy<br>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<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain score | Post-operative pain score on an 11 point NRS scale | 24 hours post-operatively following total laparoscopic hysterectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain score | Post-operative pain score on an 11 point NRS scale | 72 hours post-operatively following total laparoscopic hysterectomy | 
| Patient reported quantity of narcotics used post-operatively | Patient reported quantity of narcotics used post-operatively | 24 and 72 hours post-operatively following total laparoscopic hysterectomy | 
| Quality of life score as measured by the validated Abdominal Surgery Impact Scale | 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 | Surgical recovery score as measured by the validated Surgical Recovery Scale | 10-14 days post-operatively following total laparoscopic hysterectomy |