Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy

NCT01974882 | Completed

• 1 other identifier: IRB00004593
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Urologic Surgical Procedure

Keywords

abdominal surgery; cryotherapy; pain score; narcotic utilization

Outcome Measures

Primary Outcomes (1)

• Change in postoperative pain score

  Throughout the hospital stay nurses will assess patients pain levels. Patients will complete a visual analog score one hour postoperatively and then at 8am and 4 pm each day.

  Participants will be followed for the duration of hospital stay, an average of 7 days

Secondary Outcomes (1)

• Narcotic use

  Participants will be followed for the duration of hospital stay, an average of 7 days

Other Outcomes (1)

• Length of hospital stay

  Participants will be followed for the duration of hospital stay, an average of 7 days

Study Arms (2)

Cryotherapy

EXPERIMENTAL

Patients in the cryotherapy study group will have ice packs placed on their abdominal wound for the first hour following surgery.

Other: Ice pack

Control

NO INTERVENTION

No adjunctive therapy following abdominal surgery.

Interventions

Ice pack OTHER

Cryotherapy was applied via reusable ice bags filled with ice. Ice packs were immediately applied after the dressing was placed on the wound. The ice pack maintained in place for a continuous 24 hours adn was refilled as needed. After twenty-four hours, patients had the option of using ice packs for as long as they wished. The duration of ice pack usage was noted.

Cryotherapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any open transperitoneal abdominal surgery with a midline incision

You may not qualify if:

• Additional surgeries required

Sponsors & Collaborators

• Viraj Master: lead

Study Sites (2)

Grady Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University, Urology Department

Atlanta, Georgia, 30322, United States

Location

Study Officials

• Viraj Master, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Research Unit

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 4, 2013
• Study Start: May 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 4, 2013

Record last verified: 2013-10

Locations

US (2)