Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy (Ice)

Viraj Master

Status: Completed

Conditions: Urologic Surgical Procedure

Treatments: Other: Ice pack

Study type: Interventional

Funder types: Other

Identifiers

NCT01974882

IRB00004593

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any open transperitoneal abdominal surgery with a midline incision

Exclusion criteria

• Additional surgeries required

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Cryotherapy

Experimental group

Description:

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

Treatment:

Other: Ice pack

Control

No Intervention group

Description:

No adjunctive therapy following abdominal surgery.