Clinical trial NCT01388946: Analgesia in Laparoscopic Cholecystectomy
Official title: Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Chronic Postoperative Pain
Keywords: acute postoperative pain
late pain
chronic pain
wound irrigation with local anesthetic
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the analgesic consumption during the first 24 hours.

Detailed description: Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter was inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions were 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 was applied. Anesthesia was 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 was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed with sugammadex 2 mg/kg., the patient was 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 criteria: Inclusion Criteria:

* Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status 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

Primary outcomes:
measure: VAS Score Changes ( Cough) During 24 h Postoperatively
timeFrame: 24 h
Secondary outcomes:
measure: Pain Scores in the Postoperative Care Unit (PACU) at Rest
timeFrame: in PACU
measure: Pain Scores at Rest 2 h Postoperatively
timeFrame: 2 h postoperatively
measure: Pain Scores at Rest 4 h Postoperatively
timeFrame: 4 h
measure: Pain Scores at Rest 8 h Postoperatively
timeFrame: 8 h
measure: Pain Scores at Rest 24 h Postoperatively
timeFrame: 24h
measure: Pain Scores at Rest 48 h Postoperatively
timeFrame: 48 h
measure: Pain Scores During Cough in the PACU
timeFrame: PACU
measure: Pain Scores During Cough 2 h Postoperatively
timeFrame: 2 h
measure: Pain Scores During Cough 4 h Postoperatively
timeFrame: 4 h
measure: Pain Scores During Cough 8 h Postoperatively
timeFrame: 8 h
measure: Pain Scores During Cough 48 h Postoperatively
timeFrame: 48 h
measure: Chronic Pain
timeFrame: one month postoperatively
measure: Chronic Pain
timeFrame: three months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Anesthesia, St Savas Hospital
city: Athens
country: Greece
facility: Aretaieio Hospital
Study officials:
affiliation: St Savvas Hospital
name: Emilia Vassi
role: PRINCIPAL_INVESTIGATOR
References: