Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
VAS Scores of Postoperative Pain Analgesic Consumption Late and Chronic Pain |
Drug: Ropivacaine 0.75 Drug: Normal Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
- 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 ]
- 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 ]
| Estimated Enrollment: | 110 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Ropivacaine |
Drug: Ropivacaine 0.75
Infusion of ropivacaine 0.75 at a rate 2 ml/h is administered, beginning after the induction of anesthesia and discontinued 24 hours postoperatively.
|
| Placebo Comparator: placebo |
Drug: Normal Saline
Infusion of normal saline at a rate 2 ml/h is administered, beginning after the induction of anesthesia and discontinued 24 hours postoperatively.
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged 30-70 years ASA I-III
- Scheduled for laparoscopic cholecystectomy
Exclusion Criteria:
- Patients with chronic pain and/or on analgesics for the last month,
- Patients with central nervous, kidney and liver disease, or allergy to local anesthetics
Contacts and Locations| Contact: Argyro Fassoulaki, MD, PhD, DEAA | +30210 9024530 | fassoula@aretaieio.uoa.gr |
| Greece | |
| Department of Anesthesia, St Savas Hospital | Recruiting |
| Athens, Greece, 11522 | |
| Contact: Aimilia Vassi, MD +30210 5562710 applevass@yahoo.gr | |
| Aretaieio Hospital | Active, not recruiting |
| Athens, Greece, 11528 | |
More Information
No publications provided
| Responsible Party: | Argyro Fassoulaki, MD, PhD, DEAA, University of Athens |
| ClinicalTrials.gov Identifier: | NCT01388946 History of Changes |
| Other Study ID Numbers: | Σ-147/03-08-10 |
| Study First Received: | June 29, 2011 |
| Last Updated: | March 20, 2012 |
| Health Authority: | Greece: Ethics Committee |
Keywords provided by University of Athens:
|
acute postoperative pain late pain chronic pain wound irrigation with local anesthetic |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Ropivacaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013