Urologic Surgical Procedure
Conditions
Keywords
abdominal surgery, cryotherapy, pain score, narcotic utilization
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.
Interventions
OTHERIce 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.
Sponsors
Viraj Master
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Any open transperitoneal abdominal surgery with a midline incision
Exclusion criteria
* Additional surgeries required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postoperative pain score | Participants will be followed for the duration of hospital stay, an average of 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic use | Participants will be followed for the duration of hospital stay, an average of 7 days | Throughout the hospital stay nurses will check the amount of narcotics patients require for pain control. All narcotic use will be documented and converted to morphine equivalents using an equianalgesic table provided by the Emory University Department of Palliative Care. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an average of 7 days | Length of hospital stay will be recorded in patient records. |
Countries
United States
Outcome results
None listed