Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy

This study is currently recruiting participants.
Verified March 2012 by University of Athens
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens
ClinicalTrials.gov Identifier:
NCT01388946
First received: June 29, 2011
Last updated: March 20, 2012
Last verified: March 2012

June 29, 2011
March 20, 2012
May 2010
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01388946 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • VAS Scores of Postoperative Pain
  • Analgesic Consumption
  • Late and Chronic Pain
  • 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.
  • 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.
  • Active Comparator: Ropivacaine
    Intervention: Drug: Ropivacaine 0.75
  • Placebo Comparator: placebo
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
September 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact: Argyro Fassoulaki, MD, PhD, DEAA +30210 9024530 fassoula@aretaieio.uoa.gr
Greece
 
NCT01388946
Σ-147/03-08-10
No
Argyro Fassoulaki, University of Athens
University of Athens
Not Provided
Not Provided
University of Athens
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP