Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery

NCT01248819 | Completed Phase 3

• 1 other identifier: AR HSG 04-2008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Cholecystectomy

Keywords

Laparoscopic Cholecystectomy; Nebulization; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Morphine consumption (mg)

  Up to 48 hours

• Time of unassisted walking

  Up to 48 hours

• Hospital morbidity

  Up to 48 hours

• Time to hospital discharge

  48 hours

Study Arms (2)

Instillation

ACTIVE COMPARATOR

Instillation of Ropivacaine 100 mg in the abdominal cavity

Drug: Ropivacaine 100 mg

Nebulization

EXPERIMENTAL

Nebulization of Ropivacaine 60 mg in the abdominal cavity

Drug: Ropivacaine 60 mg

Interventions

Ropivacaine 60 mg DRUG

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

Nebulization

Ropivacaine 100 mg DRUG

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

Instillation

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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 24, 2010
• First Posted: November 25, 2010
• Study Start: April 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: November 25, 2010

Record last verified: 2008-03

Locations

IT (1)