Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/3/2018 |
| Start Date: | February 1, 2017 |
| End Date: | July 1, 2018 |
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management in Women Undergoing Laparoscopic Hysterectomy
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.
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.
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
We found this trial at
1
site
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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