Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Double Blind Randomized Phase III Controlled Trial Comparing the Effect of Intraperitoneal Nebulization of Ropivacaine With Intraperitoneal Instillation of Ropivacaine on Pain Control After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248819
• Other study ID #: AR HSG 04-2008
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2010
• Last updated: November 24, 2010
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2008
• Source: San Gerardo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after laparoscopic cholecystectomy.

Description:

Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic cholecystectomy have provided conflicting results. One of the factors that might contribute to failure of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. A recent study reported that bupivacaine nebulization significantly reduced pain after laparoscopic cholecystectomy compared with bupivacaine instillation in the gallbladder bed. However, these investigators used a custom-made nebulization system that needs a separate gas source and tubing that is cumbersome and may not be easily available.

Recently, the investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief after laparoscopic cholecystectomy than intraperitoneal ropivacaine instillation. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization using the Aeroneb Pro® device laparoscopic cholecystectomy compared with intraperitoneal ropivacaine instillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• Ropivacaine 60 mg
Nebulization grou received intraperitoneal instillation of saline 20 ml on the gall bladder after induction of pneumoperitoneum but before dissection of gall bladder plus intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) the start of gall bladder dissection and again at the end of surgery just before deflation of pneumoperitoneum (total of 60 mg). The first ropivacaine nebulization was performed over 5-6 minutes using the Aeroneb Pro® device through the umbilical port while the other ports were being inserted, while second nebulization was performed before the withdrawal of the ports
• Ropivacaine 100 mg
Instillation group received intraperitoneal instillation of ropivacaine 0.5%, 20 ml (100 mg) on the gall bladder after induction of pneumoperitoneum but before dissection of gall bladder plus and intraperitoneal nebulization of normal saline 3 ml before the start of gall bladder dissection and again at the end of surgery just before deflation of pneumoperitoneum. The first saline nebulization was performed over 5-6 minutes using the Aeroneb Pro® device through the umbilical port while the other ports were being inserted, while second nebulization was performed before the withdrawal of the ports

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza	MB

Sponsors (2)

Lead Sponsor	Collaborator
San Gerardo Hospital	Hôpital de Hautepierre

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. Epub 2006 Dec — View Citation

Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013 — View Citation

Schlotterbeck H, Schaeffer R, Dow WA, Diemunsch P. Cold nebulization used to prevent heat loss during laparoscopic surgery: an experimental study in pigs. Surg Endosc. 2008 Dec;22(12):2616-20. doi: 10.1007/s00464-008-9841-z. Epub 2008 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	Postoperative pain was assessed by Visual analgue scale (VAS 0 to 100 points) at rest (static VAS) and after a deep inspiration or cough (dynamic VAS). The proportion of patients with adequate pain control after surgery (dynamic VAS < 3) will also be assessed.	48 hours	No
Secondary	Morphine consumption (mg)	The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display	Up to 48 hours	No
Secondary	Time of unassisted walking	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.	Up to 48 hours	No
Secondary	Hospital morbidity	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.	Up to 48 hours	Yes
Secondary	Time to hospital discharge	We define hospital stay as the elapsed time between surgery and hospital discharge	48 hours	No