Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery

NCT00823576 | Terminated Phase 4

• 1 other identifier: 08-CIR-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Because local anesthetic infiltration has not been comparated to continuous infusion after spine fusion surgery, the investigators designed this study to determine whether this technique could enhance analgesia and improve patient outcome after posterior lumbar arthrodesis. The Main Objective of the study is to compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot infiltration and a continuous infiltration of Ropivacaine during 48 hours. In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL, and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h. The secondary outcomes are the consumption of morphine,the rate of the nausea and the postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration of hospital stay and the persistence of residual pain.

Conditions

Postoperative Pain

Keywords

Arthodeses rachis lombar; Spinal Surgery

Outcome Measures

Primary Outcomes (1)

• Primary end points Principal: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48.

  2 days

Secondary Outcomes (1)

• The consumption of morphine mg-The rate of the nausea and the postoperative vomits defined-Delay up to the first rise-Delay will be estimated in hours enter the end of the intervention surgery and the first one night

  2 days

Study Arms (2)

1

ACTIVE COMPARATOR

Group witness: one receiving a single bolus of analgesic Seepage simple person the end of intervention of 200mg of ropivacaïne 0,5 % at the level of zones it

Drug: Ropivacaine

2

ACTIVE COMPARATOR

Group catheter: receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving a single bolus of analgesic, one receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours.

1; 2

Eligibility Criteria

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

You may qualify if:

• Patients benefiting from of arthrodesis scheduled by a rachis lumbar posterior way
• Older than 18 years old
• Heavier than 50 kg
• Patients in the state health scheme
• Patients having signed consent

You may not qualify if:

• Surgery linked to an infectious, tumoral or traumatological cause
• Patients suffering of chronic pain define as patients consuming stage 3 analgesic since more than 3 months.- Patients receiving isoptine or flécaïne before surgery
• Arthrodesis on more than 3 stages
• Impossibility of cooperate with the patient
• Contra-indication for the maintain or the installation of a catheter diffusing analgesic
• Contra-indication of using local analgesic

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Nice, Alpes-Maritimes, 06001, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

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

Study Officials

• LITRICO LS Stéphane, PH

  CHU de Nice - Hôpital Pasteur - 30 ave de la Voie Romaine - 06100 Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: November 29, 2022

Record last verified: 2009-01

Locations

FR (1)