Colorectal Surgery Clinical Trial
Official title:
Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration
The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery
Status | Terminated |
Enrollment | 78 |
Est. completion date | March 2015 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - elective colorectal surgery Exclusion Criteria: - ASA > 3 - history of anti-inflammatory therapy - history of inflammatory bowl diseases - history of chronic pain treatment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | St. Franziskushospital Muenster | Muenster | |
Germany | University Hospital Muenster | Muenster | |
Germany | St. Marienhospital | Vechta |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster | International Anesthesia Research Society (IARS) |
Germany,
Cooke ED, Bowcock SA, Lloyd MJ, Pilcher MF. Intravenous lignocaine in prevention of deep venous thrombosis after elective hip surgery. Lancet. 1977 Oct 15;2(8042):797-9. — View Citation
Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. Epub 2006 Sep 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | length of postoperative hospital stay | end of hospital stay | No | |
Secondary | Hyperalgesia perioperative | postoperative day 2, 4, 8, end of hospital stay and follow-up | No | |
Secondary | Cytokine levels perioperative | before surgery and 4 hours, 2 and 4 days after surgery | No | |
Secondary | Bowel motility perioperative | days after surgery | No | |
Secondary | Length of PACU stay | end of PACU stay | No | |
Secondary | Cognitive function perioperatively | before surgery, one and four days after surgery, at end of hospital stay and follow-up | No | |
Secondary | Incidence of wound healing disturbances | within 4 weeks after surgery | No | |
Secondary | Postoperative Analgesia | until end of hospital stay | No |
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