TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT02778178
- Lead Sponsor
- University Hospital, Lille
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAP block with ropivacaine ultrasound Bilateral single shot TAP block under ultrasound guidance: 20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side TAP block with placebo Placebo Placebo administration: bilateral single shot TAP block under ultrasound guidance: 20 mL saline 0.9%, per side TAP block with placebo ultrasound Placebo administration: bilateral single shot TAP block under ultrasound guidance: 20 mL saline 0.9%, per side TAP block with ropivacaine ropivacaine plus clonidine Bilateral single shot TAP block under ultrasound guidance: 20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
- Primary Outcome Measures
Name Time Method Morphine consumption During the first 24 postoperative hours patient-controlled administration
- Secondary Outcome Measures
Name Time Method 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 sleepMorphine 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 resumption of intestinal transit Up to the end of hospital stay 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
Area peri-incisional hyperalgesia At 48 hours von frey's hair
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
Trial Locations
- Locations (1)
Hôpital Roger Salengro, CHU de Lille
🇫🇷Lille, France