Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy

NCT ID: NCT01974882

Last Updated: 2013-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-09-30

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.

Conditions

Urologic Surgical Procedure

Keywords

abdominal surgery; cryotherapy; pain score; narcotic utilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cryotherapy

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

Group Type: EXPERIMENTAL

Ice pack

Intervention Type: 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.

Control

No adjunctive therapy following abdominal surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ice pack

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Any open transperitoneal abdominal surgery with a midline incision

Exclusion Criteria

• Additional surgeries required

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viraj Master

OTHER

Sponsor Role: lead

Responsible Party

Viraj Master

Director of Clinical Research Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Viraj Master, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Hospital

Atlanta, Georgia, United States

Emory University, Urology Department

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00004593

Identifier Type: -

Identifier Source: org_study_id