NCT01743794

Brief Summary

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

Same day

First QC Date

May 9, 2012

Last Update Submit

December 5, 2012

Conditions

Lumbar Spine SurgeryThoracic Spine Surgery

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    48 hours after surgery

Secondary Outcomes (9)

  • number of patients in need of morphine in post surgery monitoring room

    1 hour after surgery

  • morphine consumption in post surgery monitoring room

    1 hour post surgery

  • consumption of morphine

    72 hours after surgery

  • global self appreciation of pain management

    at 72 hours

  • Time required for post surgery functional recovery

    participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • +4 more secondary outcomes

Study Arms (2)

ropivacaine 0.2%, wound infusion

EXPERIMENTAL
Drug: Ropivacaine

saline solution 0.9%, wound infusion

PLACEBO COMPARATOR
Drug: Saline solution 0.9%

Interventions

RopivacaineDRUG

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

ropivacaine 0.2%, wound infusion
Saline solution 0.9%DRUG

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

saline solution 0.9%, wound infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Departement of Anesthesia and Intensive Care

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

Related Publications (1)

  • 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.

    PMID: 26865083DERIVED

MeSH Terms

Interventions

RopivacaineSaline Solution

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
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

May 9, 2012

First Posted

December 6, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2011

Study Completion

July 1, 2012

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

FR(1)