Continuous Wound Infusion in Lumbar or Thoracic Surgery

Phase 2

Completed

• Conditions: Lumbar Spine Surgery; Thoracic Spine Surgery
• Interventions: Drug: Ropivacaine; Drug: Saline solution 0.9%

• Registration Number: NCT01743794
• Lead Sponsor: University Hospital, Grenoble

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-01
• Study First Submitted: 2012-05-09
• Study Completion: 2012-07
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-05
• Last Update Submitted: 2012-12-05
• Study First Posted: 2012-12-06
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine 0.2%, wound infusion	Ropivacaine	-
saline solution 0.9%, wound infusion	Saline solution 0.9%	-

Primary Outcome Measures

Name	Time	Method
morphine consumption	48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Score for pain intensity	until 72 hours after surgery
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

Trial Locations

Locations (1)

University Hospital, Departement of Anesthesia and Intensive Care; 🇫🇷 Grenoble, Rhone Alpes, France