Pain, Postoperative Clinical Trial
Official title:
Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial
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.
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.
;
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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