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Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery (ICALP)

Primary Purpose

Hyperalgesia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ropivacaine / Placebo
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperalgesia focused on measuring Posterior lumbar arthrodesis, Degenerative spine, Postoperative analgesia, Local anesthesic, Continuous wound infusion catheter, Pain, lumbar vertebrae, Spinal fusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative pain score : Visual Analog Scale (VAS)

Secondary Outcome Measures

Blood dosages of total ropivacaine
Clinical tolerances of catheter
Pain score :visual analog scale (VAS)
Static hyperalgesia using von Frey filaments
Postoperative rehabilitation neuropathic pain

Full Information

First Posted
January 19, 2009
Last Updated
June 19, 2012
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00825422
Brief Title
Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery
Acronym
ICALP
Official Title
Assessment of Efficacy and Safety of Continuous Wound Infiltration With Local Anesthesics Through a Parietal Paravertebral Catheter for Postoperative Analgesia After Posterior Lumbar Arthrodesis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Blockade of parietal nociceptive afferents by the use of continuous wound infiltration with local anesthetics may be beneficial in a multimodal approach to postoperative pain management after major surgery. The role of continuous wound parietal paravertebral infiltration of ropivacaine for pain relief and postoperative rehabilitation after posterior lumbar arthrodesis will be evaluated in a randomized, monocentric, double-blinded, superiority controlled trial. The general purpose of this clinical research is the assessment of efficacy and safety of continuous wound infiltration with ropivacaine through a parietal paravertebral catheter for postoperative analgesia, and his repercussions at mid (two months) and long (six months)-term after posterior lumbar arthrodesis on degenerative spine. The principal purpose concerns the assessment of postoperative analgesic efficacy at mid-term (two months after surgery) of continuous wound infiltration with ropivacaine (compared with saline solution), through a parietal paravertebral multi-holed catheter, after posterior lumbar arthrodesis. After obtaining written informed consents, the patients scheduled to undergo posterior lumbar arthrodesis on degenerative spine,.will be randomly allocated to receive a continuous wound infusion of either 0.2% ropivacaine (ropivacaine group A) or 0.9% saline (control group B) when they will arrive in the operating room. The surgeon will perform a standardized posterior median incision at the level of lumbar intervertebral instability. Before putting retractors, he will infiltrate all surgical strata and the paraspinal muscles all long the wound bilaterally with a solution of ropivacaine 0.5% 20 mL (group A) or with a solution of 0,9% NaCl 20 ml (group B). At the end of surgery, a multi-holed wound catheter will be placed by the surgeon, under direct visualization, in the paravertebral space ; between the muscle fascia and subcutaneous tissues all along the wound, and fixed at the skin by a stitch. The patients will be thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (study group) (5-ml bolus followed by an infusion of 8 ml/h during 48 h) or the same protocol with 0.9% NaCl (control group), thanks to a prefilled elastomeric pump (400ml), set to deliver a 8-ml/h connected with the catheter. In addition, all patients will receive patient-controlled intravenous morphine analgesia. After the induction, the anaesthesist will install a peripheral venous catheter for each patient in order to make blood samples easier (eight peroperative and two postoperative blood samples for each patient, with the aim of ropivacaine pharmacokinetic study).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperalgesia
Keywords
Posterior lumbar arthrodesis, Degenerative spine, Postoperative analgesia, Local anesthesic, Continuous wound infusion catheter, Pain, lumbar vertebrae, Spinal fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
first bolus of 20 ml of ropivacaine(5mg/ml) and continuous infiltration (8ml/h)of ropivacaine (2mg/ml)
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
first bolus of 20 ml of physiological saline solution(9%) and continuous infiltration (8ml/h)of physiological saline solution(9%)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine / Placebo
Intervention Description
Wound infiltration with local anesthesics/placebo through a parietal paravertebral catheter
Primary Outcome Measure Information:
Title
Postoperative pain score : Visual Analog Scale (VAS)
Time Frame
Two months after surgery
Secondary Outcome Measure Information:
Title
Blood dosages of total ropivacaine
Time Frame
Peroperative
Title
Clinical tolerances of catheter
Time Frame
until 5 days after surgery
Title
Pain score :visual analog scale (VAS)
Time Frame
24h, 48h, 5 days, 2 and 6 months after surgery
Title
Static hyperalgesia using von Frey filaments
Time Frame
48h, 5 days, 2 and 6 months after surgery
Title
Postoperative rehabilitation neuropathic pain
Time Frame
2 and 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geneviève CHENE, Professor
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cécile DEGRYSE, MD
Organizational Affiliation
Univestity Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery

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