Urologic Surgical ProcedureIceNCT01974882
Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy
A study testing Ice pack in people with Urologic Surgical Procedure, run by Viraj Master at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Urologic Surgical Procedure
- What is being tested?
- Ice pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any open transperitoneal abdominal surgery with a midline incision
Who cannot join
- Additional surgeries required
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Hospital
Atlanta, Georgia, 30303
Emory University, Urology Department
Atlanta, Georgia, 30322
About this study
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.
Read the 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
- Being tested
- Ice pack
- Keywords
- abdominal surgery, cryotherapy, pain score, narcotic utilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice packOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Patients in the cryotherapy study group will have ice packs placed on their abdominal wound for the first hour following surgery. Receives: Other: Ice pack |
| Control | No intervention | No adjunctive therapy following abdominal surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of hospital stay, an average of 7 days
Secondary outcomes (1)
Narcotic use
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.
Measured: Participants will be followed for the duration of hospital stay, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viraj Master
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Viraj Master, Emory University
- Investigators
- Viraj Master, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974882
- Sponsor's protocol ID
- IRB00004593
- Acronym
- Ice
- Status last verified
- Oct 2013
- First submitted
- 18 Oct 2013
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy
- ClinicalTrials.gov ID
- NCT01974882
- Acronym / sponsor ID
- Ice / IRB00004593
- Conditions
- Urologic Surgical Procedure
- Keywords
- abdominal surgery, cryotherapy, pain score, narcotic utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Viraj MasterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: Ice packPatients in the cryotherapy study group will have ice packs placed on their abdominal wound for the first hour following surgery. |
| Control | No intervention | –No adjunctive therapy following abdominal surgery. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any open transperitoneal abdominal surgery with a midline incision
Key exclusion criteria (1 listed)
- Additional surgeries required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice packCryotherapy 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. | Other | Cryotherapy |
Primary outcome
Change in postoperative pain score
Time frame: 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.
1 secondary outcome
Narcotic use
Time frame: Participants will be followed for the duration of hospital stay, an average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viraj Master, MD, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice pack in people with Urologic Surgical Procedure, run by Viraj Master at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative pain score (time frame: Participants will be followed for the duration of hospital stay, an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2013.