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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129464
• Other study ID #: FLA 16-111
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: October 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• Cold therapy via reusable cold gel pack
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Clinic Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total amount of narcotics used post-operatively	Total amount of narcotics used post-operatively	10-14 days postoperatively following total laparoscopic hysterectomy
Primary	Post-operative pain score	Post-operative pain score on an 11 point NRS scale	24 hours post-operatively following total laparoscopic hysterectomy
Secondary	Post-operative pain score	Post-operative pain score on an 11 point NRS scale	72 hours post-operatively following total laparoscopic hysterectomy
Secondary	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
Secondary	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
Secondary	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