Low Back Pain, Spine Surgery, Spondylolisthesis
Conditions
Brief summary
Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption
Detailed description
ALIF is a commonly performed procedure for the treatment of degenerative diseases of the lumbar spine or spondylolisthesis. This technique has many advantages attributed to the absence of posterior spinal muscular pain, a more direct visualization of the disk space, lower incidence of neurological injuries… However, patients experienced moderate to high post operative parietal abdominal pain due to this specific anterior approach. The systematic need for opioids administration may cause many complications and delay the post operative recovery time. The TAP block has been described as an effective pain control technique after various lower abdominal surgeries, reducing both pain scores and 24 hours opioids consumption. However the analgesic efficacy of this technique on specific parietal abdominal pain experienced after spine surgery by anterior approach is not clear
Interventions
DRUGTAP block ropivacaine
DRUGGeneral anesthesia
Induction PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml CISATRACURIUM 2mg/ml if necessary DEXAMETHASONE 8 mg KETAMINE 0,15mg/kg Maintenance PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with age above 18 years old * Patients scheduled for spine surgery by anterior approach * Patient who signed an informed consent form
Exclusion criteria
* Allergy to ropivacaine * Weight \< 50 kg * Contra indication to TAP block : sepsis in the point of draining, bleeding disorder * Contra indication to paracetamol: severe hepatic insufficiency * Contra indication to ketoprofen: age ≥ 75 years, renal insufficiency, previous gastric ulcer, allergy * Contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, allergy * Known allergy to active substance or at least to one excipient (propofol, paracetamol, morphine, remifentanil, cisatracurium) * Allergy to fentanyl, atracurium, or benzin sulfonic acid derivative, to propacetamol * Convulsions or previous convulsive disorder * Severe respiratory insufficiency * Abnormal hemostasis or anticoagulant treatment because of possible intramuscular injection * Morphine intake 24 hours before surgery * Chronic use of morphine, gabapentin, pregabalin * Pregnancy or breastfeeding * Patient unable to use Patient Controlled Analgesia (PCA) (old patient depends…) * Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morphine consumption in the first 24 hours after spine surgery by anterior approach | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption in the first 48 hours after spine surgery by anterior approach | 48 hours | — |
| Assessment of pain | 1, 6, 12, 24 and 48 hours | Numerical Analogue score |
| Assessment of post operative nausea or vomiting | 48 hours | Occurence of nausea or vomiting episodes over 48 hours |
| Delay before resumption of transit | Day 1 | Number of days between end of surgery and resumption of transit |
| Delay before the first lift | Day 1 | Number of hours between end of surgery and the first lift |
| Duration of hospitalization | Day 1 | — |
| Patient satisfaction | 48 hours | Satisfaction questionnaire |
| Delay before first morphine administration | Day 1 | Number of hours between end of surgery and first morphine administration |
Countries
France
Outcome results
None listed