Local Anesthetic Nebulization for Pain Control After Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247857
• Other study ID #: AR HSG 02-2008
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2010
• Last updated: November 23, 2010
• Start date: April 2008
• Est. completion date: March 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

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2009
• Est. primary completion date: March 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 30 mg
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.
• Ropivacaine 30 mg
intraperitoneal Nebulization of normal saline 3 ml before surgery and intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) 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
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.

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 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.	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	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	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