Continuous Wound Infusion in Lumbar or Thoracic Surgery

Lumbar Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743794
• Other study ID #: 1008
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 9, 2012
• Last updated: December 5, 2012
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spine Surgery
• Thoracic Spine Surgery

Intervention

Drug:
• Ropivacaine
wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
• Saline solution 0.9%
wound infusion, 0.9%, bolus 10mL followed by 8 mL/h

Locations

Country	Name	City	State
France	University Hospital, Departement of Anesthesia and Intensive Care	Grenoble	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption		48 hours after surgery	No
Secondary	number of patients in need of morphine in post surgery monitoring room		1 hour after surgery	No
Secondary	morphine consumption in post surgery monitoring room		1 hour post surgery	No
Secondary	consumption of morphine		72 hours after surgery	No
Secondary	global self appreciation of pain management		at 72 hours	No
Secondary	Time required for post surgery functional recovery		participants will be followed for the duration of hospital stay, an expected average of 3 weeks	No
Secondary	Adverse effects of morphine		72 hours after surgery	Yes
Secondary	hospitalization delay		participants will be followed for the duration of hospital stay, an expected average of 3 weeks	No
Secondary	asked bolus divided by delivered bolus		until 72 hours after surgery	No
Secondary	Score for pain intensity		until 72 hours after surgery	No