Clinical trial NCT04402450: Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia
Official title: A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Postoperative Pain
Weakness, Muscle
Motor Activity
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized comparison between two analgesic techniques
Primary purpose: SUPPORTIVE_CARE

Brief summary: In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components. In this randomized trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the hypothesis that PENG block will result in significantly less motor block compared to SFIB.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35 (kg/m2)

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy (assessed by history and physical examination)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤a100, International Normalized Ratio ≥01.4 or prothrombin time ≥ 50)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* Allergy to local anesthetics (LAs)
* Pregnancy
* Prior surgery in the corresponding side of the inguinal or suprainguinal area
* Chronic pain syndromes requiring opioid intake at home

Primary outcomes:
measure: Presence of quadriceps motor block (defined as paralysis or paresis).
timeFrame: 6 hours after block performance
Secondary outcomes:
measure: Block performance time
timeFrame: 1 hour after surgery
measure: Static and dynamic pain
timeFrame: 3 hours after the block
measure: Static and dynamic pain
timeFrame: 6 hours after the block
measure: Static and dynamic pain
timeFrame: 12 hours after the block
measure: Static and dynamic pain
timeFrame: 18 hours after the block
measure: Static and dynamic pain
timeFrame: 24 hours after the block
measure: Static and dynamic pain
timeFrame: 36 hours after the block
measure: Static and dynamic pain
timeFrame: 48 hours after the block
measure: Postoperative morphine consumption
timeFrame: 24 hours after the block
measure: Postoperative morphine consumption
timeFrame: 48 hours after the block
measure: Sensory block
timeFrame: 3 hours after the block
measure: Sensory block
timeFrame: 6 hours after the block
measure: Sensory block
timeFrame: 24 hours after the block
measure: Presence of quadriceps motor block (defined as paralysis or paresis).
timeFrame: 3 hours after the block
measure: Presence of quadriceps motor block (defined as paralysis or paresis).
timeFrame: 24 hours after the block
measure: Hip adduction strength.
timeFrame: 3 hours after the block
measure: Hip adduction strength.
timeFrame: 6 hours after the block
measure: Hip adduction strength.
timeFrame: 24 hours after the block
measure: Block-related complications
timeFrame: 1 hour after the block
measure: Postoperative opioid related side effects
timeFrame: 48 hours after the block
measure: Inability to perform physiotherapy due to motor block
timeFrame: Postoperative day 1
measure: Inability to perform physiotherapy due to motor block
timeFrame: postoperative day 2
measure: Inability to perform physiotherapy due to pain
timeFrame: postoperative day 1
measure: Inability to perform physiotherapy due to pain
timeFrame: postoperative day 2
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitan
Study officials:
References:
citation: Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
citation: Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
citation: Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.