Clinical trial NCT01974882: Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy
Official title: Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Surgical Procedure
Keywords: abdominal surgery
cryotherapy
pain score
narcotic utilization
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Postoperative pain is an unavoidable consequence of open abdominal surgery. Although cryotherapy, the application of ice to a surgical wound site, has been shown to be effective in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not been assessed in patients who undergo major open abdominal operations. We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcome measure. This would result in less narcotic analgesia usage, and shorter hospital stays as secondary outcome measures.

Detailed description: Objectives:

This study will attempt to assess the impact of cryotherapy on post-surgical inflammation and narcotic use. End-points for the study will be patient use of narcotics and pain level, regularly measured by nursing staff.

Patient Selection:

This study will accept all consecutive consenting patients who visit the Grady Hospital and Emory University urology clinics who require abdominal surgery.The study will require 55 patients, based on prior power calculations.

Registration/Randomization:

Because this study will enroll all consenting patients, no registration is required. Patients will be enrolled by their urologist during a standard visit. With consent, the urologist will direct the patient to the researcher. Patients will be randomized to either cryotherapy or no adjunctive therapy following abdominal surgery.

Therapy:

Patients in the cryotherapy study group will have ice packs placed on their abdominal wound for 24 hours following surgery.After 24 hours, patients had the option of using ice packs for as long as they wished.

Patient Assessment:

Patients will be assessed by the nursing staff as they would otherwise be assessed postsurgically.

Data Collection:

During recovery time in the hospital, nurses will monitor both groups of patients as they do all patients. As with all patients, nurses will ask about pain levels and check the amount of narcotics you require for pain control. This study will not require any additional effort on patients' part. Once they are discharged, patient participation in the study will be complete.

Eligibility criteria: Inclusion Criteria:

* Any open transperitoneal abdominal surgery with a midline incision

Exclusion Criteria:

* Additional surgeries required

Primary outcomes:
measure: Change in postoperative pain score
timeFrame: Participants will be followed for the duration of hospital stay, an average of 7 days
Secondary outcomes:
measure: Narcotic use
timeFrame: Participants will be followed for the duration of hospital stay, an average of 7 days
Other outcomes:
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an average of 7 days
Locations:
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University, Urology Department
state: Georgia
Study officials:
affiliation: Emory University
name: Viraj Master, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: