Clinical trial NCT02778178: TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study
Official title: Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block After Lumbar Spine Surgery Through Anterior Approach (Anterior Lumbar or Direct Lateral Interbody Fusion): a Prospective, Randomized, Double-blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption
timeFrame: During the first 24 postoperative hours
Secondary outcomes:
measure: intraoperative sufentanil consumption
timeFrame: At the end of anesthesia
measure: Sedation scale
timeFrame: During the first 6 hours
measure: Morphine consumption
timeFrame: between the 24 and the 48 postoperative hours
measure: Postoperative nausea and vomiting (PONV) Score
timeFrame: first 24 postoperative hours
measure: Antiemetics consumption
timeFrame: During the first 24 postoperative hours
measure: resumption of intestinal transit
timeFrame: Up to the end of hospital stay
measure: visual analog scale
timeFrame: At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery
measure: Area peri-incisional hyperalgesia
timeFrame: At 48 hours
measure: Questionnaire Douleur de Saint-Antoine (QDSA) ,
timeFrame: At Baseline, At 3 and 6 months after surgery
measure: Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
timeFrame: At Baseline, At 3 and 6 months after surgery
measure: Sullivan's "pain catastrophising scale",
timeFrame: At Baseline, At 3 and 6 months after surgery
measure: Hospital Anxiety and Depression Scale (HAD scale),
timeFrame: At Baseline, At 3 and 6 months after surgery
measure: Oswestry score
timeFrame: At Baseline, At 3 and 6 months after surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Benoit Tavernier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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