Uterine Cancer Clinical Trial
— PoPuLAROfficial title:
A Comparison Between Continuous Infusion vs. Patient Controlled Intraabdominal Injection of Local Anesthetics for Treatment of Postoperative Pain After Abdominal Hysterectomy. A Randomized, Double-blind Study.
Verified date | May 2014 |
Source | Örebro University, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | Institutional Review Board, Sweden: |
Study type | Interventional |
Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 75 Years |
Eligibility |
Inclusion Criteria: - ASA 1-2 - 30 - 75 yrs - Informed consent - 50 - 100 kg Exclusion Criteria: - Allergy to LA - Chronic pain - Major liver/kidney insufficiency - AV Block 1-2 Participation in another clinical trial |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Örebro University Hospital | Örebro |
Lead Sponsor | Collaborator |
---|---|
Örebro University, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morphine consumption | Total rescue morphine consumption during 0 - 24 h would be the primary endpoint | 0 - 24 h postoperatively | No |
Secondary | Postoperative pain | Postoperative pain measured on the numeric rating scale (0 - 10) would be measured at 4 h | 4 h postoperatively | No |
Secondary | Plasma concentration of lidocaine | The plasma concentration of LA lidocaine would be analysed at 24 h in order to assess whether the LA absorption from the abdomen is similar to that administered intravenously. | 24 h | Yes |
Secondary | Length of Hospital stay | The time to discharge home would be assessed using standardized criteria for home discharge. | 1-5 days | No |
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