N/A
N=56
Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03129464 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Post-operative Pain Score — 4; 4.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cold therapy via reusable cold gel pack (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cleveland Clinic Florida
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Pain Score |
2; 2.5 | — |
| SECONDARY Post-operative Pain Score |
2; 2.5 | — |
| SECONDARY Patient Reported Quantity of Narcotics Used Post-operatively |
2.52; 4.78 | — |
| SECONDARY Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale |
43.8; 45.7 | — |
| SECONDARY Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale |
39.7; 38 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03129464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.