Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. However, the additional anterior approach conveys specific concerns, including abdominal pain that may delay recovery after surgery. The transversus abdominis plane (TAP) block is a validated approach for postoperative pain relief following abdominal surgeries. There is currently no evidence of the possible benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind, placebo-controlled study is to demonstrate a \>35% reduction in opioid consumption during the 24h following ALIF/DLIF surgery.
Clinical trial : therapeutic, prospective, randomized,double blind, placebo-controlled, with parallel group, of superiority, in intention to treat, monocentric study. The main steps of the study are: * preoperative assessment of eligibility * exclusion and inclusion criteria, written informed consent, baseline preoperative assessment (see specific section) * randomization (using a computer generated list) immediately before induction of anesthesia * TAP block: ropivacaine + clonidine (experimental group, n=20) OR saline (control group; n=20) * anesthesia (propofol, sufentanil, cisatracurium, ketamine and desflurane) and postoperative analgesia (paracetamol, ketoprofen, nefopam, and patient-controlled analgesia with morphine) similar in both groups * surgical procedure * primary outcome parameter (morphine consumption first 24 hours; see specific section) * secondary endpoints (see specific section, up to 6 months following surgery)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
20 mL saline 0.9%, per side
Hôpital Roger Salengro, CHU de Lille
Lille, France
Morphine consumption
patient-controlled administration
Time frame: During the first 24 postoperative hours
intraoperative sufentanil consumption
infusion adjusted according to heart rate and arterial pressure
Time frame: At the end of anesthesia
Sedation scale
using WHO Sedation scale \- 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep
Time frame: During the first 6 hours
Morphine consumption
patient-controlled administration
Time frame: between the 24 and the 48 postoperative hours
Postoperative nausea and vomiting (PONV) Score
Measure the presence and severity of postoperative nausea and vomiting the PONV score :- 1 = mild /- 2 = moderate / - 3 = severe
Time frame: first 24 postoperative hours
Antiemetics consumption
Time frame: During the first 24 postoperative hours
resumption of intestinal transit
Time frame: Up to the end of hospital stay
visual analog scale
Measure the pain severity
Time frame: At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery
Area peri-incisional hyperalgesia
von frey's hair
Time frame: At 48 hours
Questionnaire Douleur de Saint-Antoine (QDSA) ,
evaluation with validated scores for chronic and neuropathic pains
Time frame: At Baseline, At 3 and 6 months after surgery
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
evaluation with validated scores for chronic and neuropathic pains
Time frame: At Baseline, At 3 and 6 months after surgery
Sullivan's "pain catastrophising scale",
evaluation with validated scores for chronic and neuropathic pains
Time frame: At Baseline, At 3 and 6 months after surgery
Hospital Anxiety and Depression Scale (HAD scale),
evaluation with validated scores for chronic and neuropathic pains
Time frame: At Baseline, At 3 and 6 months after surgery
Oswestry score
evaluation with validated scores for chronic and neuropathic pains
Time frame: At Baseline, At 3 and 6 months after surgery
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