Clinical trial NCT03129464: Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management
Official title: Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management in Women Undergoing Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-operative Pain Score
timeFrame: 24 hours post-operatively following total laparoscopic hysterectomy
Secondary outcomes:
measure: Post-operative Pain Score
timeFrame: 72 hours post-operatively following total laparoscopic hysterectomy
measure: Patient Reported Quantity of Narcotics Used Post-operatively
timeFrame: 72 hours post-operatively following total laparoscopic hysterectomy
measure: Quality of Life Score as Measured by the Validated Abdominal Surgery Impact Scale
timeFrame: 72 hours post-operatively following total laparoscopic hysterectomy
measure: Surgical Recovery Score as Measured by the Validated Surgical Recovery Scale
timeFrame: 10-14 days post-operatively following total laparoscopic hysterectomy
Other outcomes:
measure: Total Amount of Narcotics Used Post-operatively
timeFrame: 10-14 days postoperatively following total laparoscopic hysterectomy
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Michael L Sprague, MD
role: PRINCIPAL_INVESTIGATOR
References: