Local Anesthetic Nebulization for Pain Control After Laparoscopic Cholecystectomy

NCT01247857 | Completed Phase 3

• 1 other identifier: AR HSG 02-2008
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Cholecystectomy

Keywords

Laparoscopic Cholecystectomy; Nebulization; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Time of unassisted walking

  Up to 48 hours

• Morphine consumption (mg)

  Up to 48 hours

• Hospital morbidity

  Up to 48 hours

• Time to hospital discharge

  48 hours

Study Arms (3)

Preoperative Nebulization

ACTIVE COMPARATOR

Nebulization of 30 mg of Ropivacaine in the peritoneal cavity before surgery

Drug: Ropivacaine 30 mg

Postoperative Nebulization

ACTIVE COMPARATOR

Nebulization of 30 mg of Ropivacaine in the peritoneal cavity after surgery

Drug: Ropivacaine 30 mg

Control

PLACEBO COMPARATOR

Nebulization of normal saline 3 ml before and after surgery

Drug: Saline

Interventions

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.

Preoperative Nebulization

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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Gerardo Hospital: lead
• Hôpital de Hautepierre: collaborator

Study Sites (1)

San Gerardo Hospital

Monza, MB, 20052, Italy

Location

Related 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. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.

  PMID: 17180268 RESULT

• 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.0b013e318176fa1c.

  PMID: 18633034 RESULT

• 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.

  PMID: 18347861 RESULT

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pablo M Ingelmo, MD

  San Gerardo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 24, 2010
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 24, 2010

Record last verified: 2008-03

Locations

IT (1)