CHU de Rennes
Rennes, 35033, France
NCT Number: NCT02884440
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
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Rennes, 35033, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 24 hours
Time frame: 48 hours
Time frame: 1, 6, 12, 24 and 48 hours
Numerical Analogue score
Time frame: 48 hours
Occurence of nausea or vomiting episodes over 48 hours
Time frame: Day 1
Number of hours between end of surgery and first morphine administration
Time frame: Day 1
Number of hours between end of surgery and the first lift
Time frame: Day 1
Number of days between end of surgery and resumption of transit
Time frame: Day 1
Time frame: 48 hours
Satisfaction questionnaire
Rennes University Hospital
Other
Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study
Acronym: TAP ALIF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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