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Completed

NCT Number: NCT01388946

Analgesia in Laparoscopic Cholecystectomy

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aretaieio Hospital, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine 0.75

Drug

Other names: Naropeine

normal saline

Drug

Other names: 0.9% saline

Primary outcomes

  1. VAS Score Changes ( Cough) During 24 h Postoperatively

    Time frame: 24 h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

Secondary outcomes

  1. Pain Scores in the Postoperative Care Unit (PACU) at Rest

    Time frame: in PACU

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  2. Pain Scores at Rest 2 h Postoperatively

    Time frame: 2 h postoperatively

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  3. Pain Scores at Rest 4 h Postoperatively

    Time frame: 4 h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  4. Pain Scores at Rest 8 h Postoperatively

    Time frame: 8 h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  5. Pain Scores at Rest 24 h Postoperatively

    Time frame: 24h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  6. Pain Scores at Rest 48 h Postoperatively

    Time frame: 48 h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  7. Pain Scores During Cough in the PACU

    Time frame: PACU

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  8. Pain Scores During Cough 2 h Postoperatively

    Time frame: 2 h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  9. Pain Scores During Cough 4 h Postoperatively

    Time frame: 4 h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  10. Pain Scores During Cough 8 h Postoperatively

    Time frame: 8 h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  11. Pain Scores During Cough 48 h Postoperatively

    Time frame: 48 h

    Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.

  12. Chronic Pain

    Time frame: one month postoperatively

    Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively

  13. Chronic Pain

    Time frame: three months

    Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 7, 2011
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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