Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia

Postoperative Pain Clinical Trial

Official title:

A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402450
• Other study ID #: OAIC 1111/20
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: September 2021
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 28, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Motor Activity
• Muscle Weakness
• Postoperative Complications
• Postoperative Pain
• Weakness, Muscle

Intervention

Procedure:
• Ultrasound-guided suprainguinal fascia iliaca nerve block
After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.
• Ultrasound-guided pericapsular nerves group of the hip block
After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (2)

Girón-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of quadriceps motor block (defined as paralysis or paresis).	Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).	6 hours after block performance
Secondary	Block performance time	temporal interval between the start of skin disinfection and the end of LA injection through the block needle	1 hour after surgery
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)	3 hours after the block
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)	6 hours after the block
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)	12 hours after the block
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)	18 hours after the block
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)	24 hours after the block
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)	36 hours after the block
Secondary	Static and dynamic pain	Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)	48 hours after the block
Secondary	Postoperative morphine consumption	consumption of intravenous morphine registered by a patient controlled analgesia device	24 hours after the block
Secondary	Postoperative morphine consumption	consumption of intravenous morphine registered by a patient controlled analgesia device	48 hours after the block
Secondary	Sensory block	Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)	3 hours after the block
Secondary	Sensory block	Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)	6 hours after the block
Secondary	Sensory block	Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)	24 hours after the block
Secondary	Presence of quadriceps motor block (defined as paralysis or paresis).	Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).	3 hours after the block
Secondary	Presence of quadriceps motor block (defined as paralysis or paresis).	Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).	24 hours after the block
Secondary	Hip adduction strength.	Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.	3 hours after the block
Secondary	Hip adduction strength.	Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.	6 hours after the block
Secondary	Hip adduction strength.	Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.	24 hours after the block
Secondary	Block-related complications	vascular puncture, paresthesia or systemic local anesthetic toxicity	1 hour after the block
Secondary	Postoperative opioid related side effects	Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression	48 hours after the block
Secondary	Inability to perform physiotherapy due to motor block	Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated leg.	Postoperative day 1
Secondary	Inability to perform physiotherapy due to motor block	Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg.	postoperative day 2
Secondary	Inability to perform physiotherapy due to pain	Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated leg.	postoperative day 1
Secondary	Inability to perform physiotherapy due to pain	Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg.	postoperative day 2