Continuous Wound Infusion in Lumbar or Thoracic Surgery

Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study

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".

Study Overview

• Status: Completed
• Conditions: Lumbar Spine Surgery; Thoracic Spine Surgery
• Intervention / Treatment: Drug: Ropivacaine; Drug: Saline solution 0.9%

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Rhone Alpes
    • Grenoble, Rhone Alpes, France, 38000
      • University Hospital, Departement of Anesthesia and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ropivacaine 0.2%, wound infusion	Drug: Ropivacaine; wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
Placebo Comparator: saline solution 0.9%, wound infusion	Drug: Saline solution 0.9%; wound infusion, 0.9%, bolus 10mL followed by 8 mL/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
morphine consumption	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Adverse effects of morphine	72 hours after surgery
hospitalization delay	participants will be followed for the duration of hospital stay, an expected average of 3 weeks
asked bolus divided by delivered bolus	until 72 hours after surgery
Score for pain intensity	until 72 hours after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 5, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 1008