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Continuous Wound Infusion in Lumbar or Thoracic Surgery

NCT ID: NCT01743794

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

Brief Summary

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Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.

Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".

Detailed Description

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Conditions

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Lumbar Spine Surgery Thoracic Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ropivacaine 0.2%, wound infusion

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion

saline solution 0.9%, wound infusion

Group Type PLACEBO_COMPARATOR

Saline solution 0.9%

Intervention Type DRUG

wound infusion, 0.9%, bolus 10mL followed by 8 mL/h

Interventions

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Ropivacaine

wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion

Intervention Type DRUG

Saline solution 0.9%

wound infusion, 0.9%, bolus 10mL followed by 8 mL/h

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adults
* \> 18 years
* Physical status score I, II or III (American Society of Anesthesiologists)
* lumbar or thoracic spine surgery with arthrodesis through posterior only approach
* signed informed consent
* beneficiary of social security

Exclusion Criteria

* vulnerable persons according to law
* scoliosis surgery
* local anesthetic allergia
* contraindication to ketamine, acetaminophene, nefopam, non steroidal anti inflammatory, ropivacaine, morphine, droperidol
* long term anti platelet aggregants
* inability to comply to protocol requirements
* psychiatric disorders or cognitive disabilities
* chronic pain or long term opioids consumption
* diabetes
* obesity (BMI \> 30)
* pregnancy or lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital, Departement of Anesthesia and Intensive Care

Grenoble, Auvergne-Rhône-Alpes, France

Site Status

Countries

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France

References

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Greze J, Vighetti A, Incagnoli P, Quesada JL, Albaladejo P, Palombi O, Tonetti J, Bosson JL, Payen JF. Does continuous wound infiltration enhance baseline intravenous multimodal analgesia after posterior spinal fusion surgery? A randomized, double-blinded, placebo-controlled study. Eur Spine J. 2017 Mar;26(3):832-839. doi: 10.1007/s00586-016-4428-1. Epub 2016 Feb 10.

Reference Type DERIVED
PMID: 26865083 (View on PubMed)

Other Identifiers

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1008

Identifier Type: -

Identifier Source: org_study_id