Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery

NCT00825422 | Completed Phase 3

• 1 other identifier: CHUBX 2008/21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation. Efficient and safe methods for postoperative analgesia are, therefore, mandatory. The application of opioids are the most frequently used therapies for postoperative pain relief but it very often results side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in a multimodal approach to postoperative pain management. In the setting of spine surgery, a single bolus administration of a local anesthetic is a useful method (with a reduction in parenteral morphine consumption during the 48 first hours) but has a limited effect because of its short duration of action. Prolonged administration through a multi-holed catheter positioned by the surgeon at the end of the procedure could increase the duration of action and may thereby improve the efficacy of local wound infiltration. Easy and effective, this new modality of administration has expanded the indications for parietal infiltrations toward major painful procedures. We designed this study to determine whether local anesthetic (compared with saline solution) continuous wound infiltration during the first two days after posterior lumbar arthrodesis on degenerative spine, could improve postoperative analgesia at short-term but particularly at mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar pains (resulting in best life quality, opioid consumption limited and rehabilitation hastened) and postoperative hyperalgesia areas. The postoperative analgesic and antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and the safety of opioid administration and multi-holed parietal catheter will be compared in the two groups (control and study).

Conditions

Hyperalgesia

Keywords

Posterior lumbar arthrodesis; Degenerative spine; Postoperative analgesia; Local anesthesic; Continuous wound infusion catheter; Pain; lumbar vertebrae; Spinal fusion

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score : Visual Analog Scale (VAS)

  Two months after surgery

Secondary Outcomes (5)

• Blood dosages of total ropivacaine

  Peroperative

• Clinical tolerances of catheter

  until 5 days after surgery

• Pain score :visual analog scale (VAS)

  24h, 48h, 5 days, 2 and 6 months after surgery

• Static hyperalgesia using von Frey filaments

  48h, 5 days, 2 and 6 months after surgery

• Postoperative rehabilitation neuropathic pain

  2 and 6 months after surgery

Study Arms (2)

A

EXPERIMENTAL

first bolus of 20 ml of ropivacaine(5mg/ml) and continuous infiltration (8ml/h)of ropivacaine (2mg/ml)

Drug: Ropivacaine / Placebo

B

PLACEBO COMPARATOR

first bolus of 20 ml of physiological saline solution(9%) and continuous infiltration (8ml/h)of physiological saline solution(9%)

Drug: Ropivacaine / Placebo

Interventions

Ropivacaine / Placebo DRUG

Wound infiltration with local anesthesics/placebo through a parietal paravertebral catheter

A; B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Necessity to use safety contraceptive methods for women who can procreate
• Patients with American Society of Anesthesiologists physical status I, II or III
• Patients scheduled to undergo a posterior lumbar arthrodesis on one at three levels treated,
• Posterior lumbar arthrodesis is only executed on lumbar degenerative spine,
• A written informed consent has to sign by the patient and the investigator before beginning clinical study
• Patients affiliated with social security system

You may not qualify if:

• Pregnancy and breast-feeding
• Posterior lumbar arthrodesis exceeding three levels treated,
• Posterior lumbar arthrodesis post-traumatic or with neoplastic disorders or with the aim of correcting cord compression,
• Epilepsy not controlled through medication,
• Preoperative cognitive dysfunction or psychiatric disorders,
• Cardiac or breathing dysfunctions,
• Preoperative opioid consumption,
• Patients who have a known local anesthetic, or morphine or/and acetaminophen allergy,
• Lack of understanding about the study or inability to use the patient controlled analgesic device,
• Patients protected by the law, guardianship,
• Patients who take a share in an another clinical study in the same time,

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Hyperalgesia; Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Geneviève CHENE, Professor

  University Hospital, Bordeaux

  STUDY CHAIR

• Cécile DEGRYSE, MD

  Univestity Hospital, Bordeaux

  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: SPONSOR

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

FR (1)