Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Athens.
Recruitment status was  Recruiting
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
  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

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388946

Contacts
Contact: Argyro Fassoulaki, MD, PhD, DEAA +30210 9024530 fassoula@aretaieio.uoa.gr

Locations
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
Sponsors and Collaborators
University of Athens
  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
Chronic Pain
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
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 October 01, 2014