Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management in Women Undergoing Laparoscopic Hysterectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Postoperative
- Sponsor
- Cleveland Clinic Florida
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Post-operative Pain Score
- Status
- Completed
- Last Updated
- last year
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.
Investigators
Pamela Frazzini Padilla
Clinical Fellow
Cleveland Clinic Florida
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
Outcomes
Primary Outcomes
Post-operative Pain Score
Time Frame: 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 Outcomes
- 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)