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Completed

NCT Number: NCT01247857

Local Anesthetic Nebulization for Pain Control After Laparoscopic Cholecystectomy

Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopy. Preoperative compared with postoperative administration of analgesia remains controversial. This randomized, double blind, placebo-controlled trial compared the analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients undergoing elective laparoscopic cholecystectomy.

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Key information

Conditions

Laparoscopic Cholecystectomy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Gerardo Hospital

Monza, MB, 20052, Italy

About this study

Previous studies evaluating intraperitoneal local anesthetic administration for pain relief after laparoscopic surgery have suggested that the timing of local anesthetic administration may be critical in the success of the technique. A meta-analysis of randomized trials of intraperitoneal local anesthetic instillation in patients undergoing laparoscopic surgery found that local anesthetic instilled before surgical dissection provided superior pain relief compared to instillation at the end of surgery. Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopic surgery. Recently, Alkhamesi et al reported that bupivacaine nebulization performed at the end of laparoscopic cholecystectomy significantly reduced postoperative pain. However, clinical benefits of preoperative administration of analgesia, compared with postoperative administration, remains controversial.

The investigators hypothesized that pain relief after preoperative and postoperative ropivacaine nebulization would be similar but better than placebo.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA Score I-III
  • Scheduled for laparoscopic cholecystectomy
  • Free from pain in preoperative period
  • Not using analgesic drugs before surgery
  • Without cognitive impairment or mental retardation
  • Written informed consent

Exclusion criteria

  • Emergency/urgency surgery
  • Postoperative admission in an intensive care unit
  • Cognitive impairment or mental retardation
  • Progressive degenerative diseases of the CNS
  • Seizures or chronic therapy with antiepileptic drugs
  • Severe hepatic or renal impairment
  • Pregnancy or lactation
  • Allergy to one of the specific drugs under study
  • Acute infection or inflammatory chronic disease
  • Alcohol or drug addiction

Treatment and study plan

Ropivacaine 30 mg

Drug

Intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and intraperitoneal nebulization of normal saline 3 ml after surgery.

Nebulization was performed over 5-10 minutes using the Aeroneb Pro® device through the umbilical port during the insertion of the other ports, while postoperative nebulization was performed before the withdrawal of the ports.

Saline

Drug

Intraperitoneal nebulization of normal saline 3 ml before and after surgery. Nebulization was performed over 5-10 minutes using the Aeroneb Pro® device through the umbilical port during the insertion of the other ports, while postoperative nebulization was performed before the withdrawal of the ports.

Primary outcomes

  1. Postoperative Pain

    Time frame: 48 hours

    Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed.

Secondary outcomes

  1. Time of unassisted walking

    Time frame: Up to 48 hours

    Unassisted walking time is defined as the time in hours between PACU discharge and when the patient is able to walk out of his room and back to bed without any assistance.

  2. Morphine consumption (mg)

    Time frame: Up to 48 hours

    The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display

  3. Hospital morbidity

    Time frame: Up to 48 hours

    All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified using the anesthesia charts, surgical charts, surgical database.

  4. Time to hospital discharge

    Time frame: 48 hours

    We define hospital stay as the elapsed time between surgery and hospital discharge

Sponsors and collaborators

Lead sponsor

San Gerardo Hospital

Other

Collaborators

  • Hôpital de Hautepierre

Registry information

Official study title

Double Blind Randomized Phase III Controlled Trial Comparing the Effect of Preoperative and Postoperative Nebulization of Ropivacaine on Pain Control After Laparoscopic Cholecystectomy

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 24, 2010
Registry last updated
Nov 24, 2010

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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