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Completed

NCT Number: NCT02778178

TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Roger Salengro, CHU de Lille

Lille, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ropivacaine plus clonidine

Drug

20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side

Placebo

Drug

20 mL saline 0.9%, per side

Ultrasound

Device

Primary outcomes

  1. Morphine consumption

    Time frame: During the first 24 postoperative hours

    patient-controlled administration

Secondary outcomes

  1. intraoperative sufentanil consumption

    Time frame: At the end of anesthesia

    infusion adjusted according to heart rate and arterial pressure

  2. Sedation scale

    Time frame: During the first 6 hours

    using WHO Sedation scale

    • 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep

  3. Morphine consumption

    Time frame: between the 24 and the 48 postoperative hours

    patient-controlled administration

  4. Postoperative nausea and vomiting (PONV) Score

    Time frame: first 24 postoperative hours

    Measure the presence and severity of postoperative nausea and vomiting the PONV score :- 1 = mild /- 2 = moderate / - 3 = severe

  5. Antiemetics consumption

    Time frame: During the first 24 postoperative hours

  6. resumption of intestinal transit

    Time frame: Up to the end of hospital stay

  7. visual analog scale

    Time frame: At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery

    Measure the pain severity

  8. Area peri-incisional hyperalgesia

    Time frame: At 48 hours

    von frey's hair

  9. Questionnaire Douleur de Saint-Antoine (QDSA) ,

    Time frame: At Baseline, At 3 and 6 months after surgery

    evaluation with validated scores for chronic and neuropathic pains

  10. Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),

    Time frame: At Baseline, At 3 and 6 months after surgery

    evaluation with validated scores for chronic and neuropathic pains

  11. Sullivan's "pain catastrophising scale",

    Time frame: At Baseline, At 3 and 6 months after surgery

    evaluation with validated scores for chronic and neuropathic pains

  12. Hospital Anxiety and Depression Scale (HAD scale),

    Time frame: At Baseline, At 3 and 6 months after surgery

    evaluation with validated scores for chronic and neuropathic pains

  13. Oswestry score

    Time frame: At Baseline, At 3 and 6 months after surgery

    evaluation with validated scores for chronic and neuropathic pains

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: TAP-LIF

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 19, 2016
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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