Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy
| Tracking Information | |||||
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| First Received Date ICMJE | June 29, 2011 | ||||
| Last Updated Date | March 20, 2012 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
VAS score changes at PACU and 2, 4, 8, 24, 48 h postoperatively [ Time Frame: PACU, 2, 4, 8, 24, 48 h ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01388946 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Analgesic consumption at PACU and 2, 4, 8, 24, 48 h postoperatively [ Time Frame: PACU, 2, 4, 8, 24, 48 h ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy will not alter the intensity of postoperative pain or the analgesic consumption during the first 24 hours. |
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| Detailed Description | Patients scheduled for laparoscopic cholecystectomy are randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter is inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions are administered by means of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring is applied. Anesthesia is induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration(MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V is given within 30 min. Before wound closure each hole is infiltrated with 2 ml of ropivacaine 0.75. At the end of surgery neuromuscular block is reversed with sugammadex 2 mg/kg., the patient is extubated and transferred to the Post-anesthesia Care Unit (PACU). Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and the total amount of carbon dioxide insufflated are recorded every 5 minutes. Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale(VAS) score is above 40 mm.In the ward Lonarid tablets are given instead. VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours after surgery. The catheter is removed 24 hours after surgery. One and three months after surgery patients are interviewed by phone for the presence of pain due to surgery. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 110 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Greece | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01388946 | ||||
| Other Study ID Numbers ICMJE | Σ-147/03-08-10 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Argyro Fassoulaki, University of Athens | ||||
| Study Sponsor ICMJE | University of Athens | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Athens | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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