Pain, Postoperative
Conditions
Brief summary
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.
Detailed description
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)
Interventions
DRUGropivacaine plus clonidine
20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
DRUGPlacebo
20 mL saline 0.9%, per side
DEVICEultrasound
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man or woman over the age of 18 yr * Patients with insurance coverage * Patients able to provide free and informed consent * Patients undergoing surgery by the ALIF or DLIF approaches
Exclusion criteria
* Patients receiving opioids as chronic treatment * Patients with contra-indication to regional anesthesia or TAP block * Patients unable to consent * Patient refusal * Patients with contra-indication to any drug included in the anesthesia or analgesia protocol * Pregnancy or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | During the first 24 postoperative hours | patient-controlled administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative sufentanil consumption | At the end of anesthesia | infusion adjusted according to heart rate and arterial pressure |
| Sedation scale | During the first 6 hours | using WHO Sedation scale \- 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep |
| Morphine consumption | between the 24 and the 48 postoperative hours | patient-controlled administration |
| Postoperative nausea and vomiting (PONV) Score | first 24 postoperative hours | Measure the presence and severity of postoperative nausea and vomiting the PONV score :- 1 = mild /- 2 = moderate / - 3 = severe |
| Antiemetics consumption | During the first 24 postoperative hours | — |
| visual analog scale | At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery | Measure the pain severity |
| resumption of intestinal transit | Up to the end of hospital stay | — |
| Questionnaire Douleur de Saint-Antoine (QDSA) , | At Baseline, At 3 and 6 months after surgery | evaluation with validated scores for chronic and neuropathic pains |
| Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN), | At Baseline, At 3 and 6 months after surgery | evaluation with validated scores for chronic and neuropathic pains |
| Sullivan's pain catastrophising scale, | At Baseline, At 3 and 6 months after surgery | evaluation with validated scores for chronic and neuropathic pains |
| Hospital Anxiety and Depression Scale (HAD scale), | At Baseline, At 3 and 6 months after surgery | evaluation with validated scores for chronic and neuropathic pains |
| Oswestry score | At Baseline, At 3 and 6 months after surgery | evaluation with validated scores for chronic and neuropathic pains |
| Area peri-incisional hyperalgesia | At 48 hours | von frey's hair |
Countries
France
Outcome results
None listed