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Comparison Between 2 Techniques for Lumbar-ESPB

ConditionHip Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPapa Giovanni XXIII Hospital

About this trial

Diffusion of local anesthetics after a lumbar ESPB within fascial planes towards nerve structures is a matter of debate.

The main objective of the study is to compare the incidence of sensory block between two techniques of needle placement (superficial or translaminar) during lumbar ESPB block.

Patients are treated with lumbar ESPB (randomized to superficial or translaminar), spinal anesthesia and multimodal analgesia.

The primary endpoint will be the incidence of numbness/reduced skin sensitivity to cold (ice test) in the area innervated by the lumbar plexus. Secondary outcomes are pain and analgesic's consumption, motor block, quality of recovery and discharge ability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

primary total hip replacement

informed consent

Disqualifiers

allergies to study drugs

spinal anesthesia contraindicated

kidney failure (GFR<30)

epilepsy, psychiatric disease, neurologic deficits

Trial design

Design model

Parallel

Treatments tested in this trial

  • spinal anesthesia

    Procedure/Surgery

    spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml

  • superficial erector spinal plane block (ESPB)

    Procedure/Surgery

    Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 on top of L3 transverse process, between bone and erector spinae muscle

  • deep (inter laminar) erector spinal plane block (ESPB)

    Procedure/Surgery

    Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 between L3 and L4 transverse process, between erector spinae muscle and deep muscles

  • Dexamethasone

    Drug

    8 mg iv preoperatively

  • Ibuprofen 400 mg

    Drug

    preoperatively and postoperatively (every 8 hours)

  • Paracetamol

    Drug

    1000 mg preoperatively and postoperatively (every 8 hours)

  • Morphine

    Drug

    Patient Controlled Analgesia

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: superficial ESPBActive comparator 6 interventions
Group B: deep ESPBExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

sensory block

incidence of reduced or abolished cold sensation on the skin in the territory of lumbar plexus (anterior, medial and lateral thigh)

Time frame
24 hours

Secondary outcomes

1

motor block

block of extension and/or adduction of the thigh

Time frame
24 hours
2

postoperative pain

numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

Time frame
48 hours
3

morphine consumption

milligrams of morphine by patient controlled analgesia intravenously

Time frame
24 hours
4

quality of recovery

QoR-15 (Quality of Recovery 15 items) questionnaire - global measure of postoperative recovery, with a score ranging from 0 (extremely poor) to 150 (excellent)

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Papa Giovanni XXIII Hospital

Lead sponsor

Source ClinicalTrials.gov
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