A Phase 4 interventional study of ropivacaine plus clonidine and Placebo in Pain, Postoperative, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by University Hospital, Lille · Phase 4, Interventional, and Treatment
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:
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bilateral single shot TAP block under ultrasound guidance: 20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
Drug: ropivacaine plus clonidine · Device: ultrasound
Placebo administration: bilateral single shot TAP block under ultrasound guidance: 20 mL saline 0.9%, per side
Drug: Placebo · Device: ultrasound
20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
20 mL saline 0.9%, per side
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
Plan to share: No
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille