Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery

NCT01512914 | Completed Phase 3

• 1 other identifier: AR HSG 01-2008
• Study Type: interventional
• Target: 120
• 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 gynecologic laparoscopic surgery.

Conditions

Gynecologic Laparoscopic Surgery

Keywords

Gynecologic laparoscopic surgery; Postoperative pain; Nebulization; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  Postoperative pain was assessed by 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.

  24 hours

Secondary Outcomes (4)

• morphine consumption

  24 hours

• Unassisted walking time

  24 hours

• Hospital stay

  between surgery and discharge

• hospital morbidity

  up to discharge

Study Arms (4)

CONTROL group

PLACEBO COMPARATOR

Drug: saline

PREOPERATIVE nebulization

EXPERIMENTAL

Drug: Ropivacaine 30 mg

POSTOPERATIVE nebulization

EXPERIMENTAL

Drug: Ropivacaine 30 mg

INSTILLATION group

ACTIVE COMPARATOR

Drug: Ropivacaine 100 mg

Interventions

Ropivacaine 30 mg DRUG

preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery

PREOPERATIVE nebulization

Ropivacaine 100 mg DRUG

preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery

INSTILLATION group

saline DRUG

preoperative instillation of saline 20 ml and nebulization of saline before and after surgery

CONTROL group

Eligibility Criteria

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

You may qualify if:

• Females 18-70 years old, ASA score 1 - 3;
• scheduled for laparoscopic operative surgery in the Obstetrics and Gynecology unit;
• free from pain in preoperative period, without habitual analgesic use;
• without cognitive impairment or mental retardation, who gave a written informed consent

You may not qualify if:

• Females under 18 or over 70;
• ASA 4 or 5;
• emergency/urgency criteria, postoperative admission in a intensive care unit with sedation or ventilatory assistance; cognitive impairment or mental retardation;
• habitual analgesic use; progressive degenerative diseases of the CNS;
• convulsions or chronic therapy with antiepileptic drugs;
• severe hepatic or renal impairment;
• pregnancy or lactation;
• allergy to one of the specific substances used in the study;
• acute infectious disease or inflammatory chronic disease, alcohol or drug addiction;
• any kind of communication problem;
• neurologic or psychiatric disease;
• no written informed consent

Sponsors & Collaborators

• San Gerardo Hospital: lead

Study Sites (1)

San Gerardo Hospital

Monza, MB, 20052, Italy

Location

Related Publications (3)

• Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.

  PMID: 10910857 RESULT

• 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

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2012
• First Posted: January 19, 2012
• Study Start: May 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

IT (1)