Clinical trial NCT03860324: Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty
Official title: Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty Post-operative Analgesia With Erector Spinae Plane Block After Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain, Postoperative
Keywords: Hip Arthroplasty
Erector Spinae Plane Block
Lead sponsor: Hospital Beatriz Ângelo
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves.

Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks.

The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).


Eligibility criteria: Inclusion Criteria:

* Surgical plan for total hip replacement
* Signing of consent form to participate in the study

Exclusion Criteria:

* Patient refusal
* BMI \> 40 kg/m2
* Surgical plan for revision of hip replacement
* Patient unable to quantify pain level
* Chronic kidney disease with a Glomerular Filtration Rate \< 50ml/min
* Previously medicated with opioids
* Patient unable to perform the surgery with spinal block
* Allergy to local anesthetics
* Infection in the site of the Erector Spinae Plane or Fascia Iliaca block
* Allergy or contraindication to the use of morphine

Primary outcomes:
measure: Post-operative pain level measured by the Visual Analog Scale
timeFrame: At 6 hours post-operative
measure: Post-operative pain level measured by the Visual Analog Scale
timeFrame: At 12 hours post-operative
measure: Post-operative pain level measured by the Visual Analog Scale
timeFrame: At 24 hours post-operative
measure: Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia
timeFrame: At 24 hours post-operative
Secondary outcomes:
measure: Muscle Strength grade
timeFrame: At 12 hours post-operative
measure: Muscle Strength grade
timeFrame: At 24 hours post-operative
measure: Sensory block assessed through a temperature test
timeFrame: At 24 hours post-operative
measure: Sensory block assessed through a tactile stimulation test
timeFrame: At 24 hours post-operative
measure: Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patient
timeFrame: At 24 hours post-operative
Other outcomes:
Locations:
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo
state: Lisboa
Study officials:
affiliation: Hospital Beatriz Ângelo
name: André Carrão
role: PRINCIPAL_INVESTIGATOR
References: