Trial record 2 of 473 for:
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Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
This study is currently recruiting participants.
Verified May 2013 by Masonic Cancer Center, University of Minnesota
Sponsor:
Masonic Cancer Center, University of Minnesota
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01705288
First received: October 9, 2012
Last updated: May 30, 2013
Last verified: May 2013
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Purpose
Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Gynecologic Surgery |
Procedure: Laparotomy Drug: intravenous narcotics Drug: standard anesthesia Drug: regional anesthesia Drug: Non-steroidal anti-inflammatory drugs |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Masonic Cancer Center, University of Minnesota:
Primary Outcome Measures:
- Return to Function [ Time Frame: 1 Months ] [ Designated as safety issue: No ]The primary outcome of this study is a reduction of length of hospital stay from a mean of 5 days to 3 days.
Secondary Outcome Measures:
- Comparison of Pain Assessment [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.
- Comparison of Pain Medications Used [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]Another secondary outcome will be whether the rapid recovery protocol decreases the amount of narcotic pain medication used by patients during their hospital stay.
Other Outcome Measures:
- Comparison of Anti-Emetics Use [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]
- Comparison of Rates of Readmission to Hospital [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]
- Comparison of Complications During Readmission [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control Group (Standard Laparotomy)
Patients undergoing standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
|
Procedure: Laparotomy
Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital
Drug: intravenous narcotics
given for pain management after surgery per physician orders
Drug: standard anesthesia
inhalant or intravenous during surgery
|
|
Experimental: Rapid Recovery Group
Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital.
|
Procedure: Laparotomy
Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital
Drug: regional anesthesia
given by spinal or epidural infusion
Drug: Non-steroidal anti-inflammatory drugs
given for pain management after surgery
Other Name: NSAIDs
|
Detailed Description:
Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or standard of care (traditional laparatomy and supportive care).
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Women who are being seen at the Women's Health Center by the Gynecologic Oncology group at the University of Minnesota if planned surgery includes an exploratory laparotomy
Exclusion Criteria:
- < 19 years old
- Pregnant
- Undergoing a procedure other than laparotomy
- Scheduled to be discharged the same day of surgery
- Chronic narcotic pain medication user
- American Society of Anesthesiologists (ASA) score of > or = 3
- Any condition that would exclude women from undergoing regional anesthesia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01705288
Contacts
| Contact: Peter Argenta, M.D. | 612-626-3111 | argenta@umn.edu |
Locations
| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Peter Argenta, M.D. 612-626-3111 argenta@umn.edu | |
| Principal Investigator: Peter Argenta, M.D. | |
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
| Principal Investigator: | Peter Argenta, M.D. | Masonic Cancer Center, University of Minnesota |
More Information
No publications provided
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01705288 History of Changes |
| Other Study ID Numbers: | 2012LS096 |
| Study First Received: | October 9, 2012 |
| Last Updated: | May 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Masonic Cancer Center, University of Minnesota:
|
laparotomy hysterectomy |
Additional relevant MeSH terms:
|
Narcotics Anesthetics Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013