Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

Not Applicable

Completed

• Conditions: Hip Osteoarthritis; Pain, Acute; Pain, Postoperative; Opioid Use
• Interventions: Procedure: lumbar plexus block; Procedure: suprainguinal fascia iliaca block

• Registration Number: NCT03744065
• Lead Sponsor: University of Chile

Brief Summary

The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required.

In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting.

Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Study Start: 2018-11-19
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-23
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 ≤ 100, International Normalized Ratio ≥ 1.4 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) or morphine
• Pregnancy
• Prior surgery in the corresponding side of the lumbar o suprainguinal area
• Chronic pain syndromes requiring opioid intake at home

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar plexus block	lumbar plexus block	Patients randomized to receive an ultrasound-guided lumbar plexus block
Suprainguinal fascia iliaca block	suprainguinal fascia iliaca block	Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block

Primary Outcome Measures

Name	Time	Method
Morphine consumption over 24 hours	24 hours post block	Total morphine consumption over 24 hours post block

Secondary Outcome Measures

Name	Time	Method
Performance time	2 hours after surgery	Interval between the start of skin disinfection and the end of local anesthetic injection
Postoperative static pain at 12 hours after block	12 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative static pain at 3 hours after block	3 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative static pain at 24 hours after block	24 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 3 hours after block	3 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 24 hours after block	24 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Number of needle passes	2 hours after surgery	The initial needle insertion counted as the first pass. Any subsequent needle advancement that is preceded by a retraction of at least 10 mm counts as an additional pass
Postoperative dynamic pain at 6 hours after block	6 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Time until first morphine demand	48 hours after the block	Time until first patient-controlled analgesia morphine demand
Block assessment at 3 hours	3 hours after the block	Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.; Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.; Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Length of hospital stay	7 days after surgery	Length of hospital stay after surgery
Block assessment at 6 hours	6 hours after the block	Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.; Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.; Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Incidence of Inability to perform physiotherapy	24 hours after the block	Inability to perform physiotherapy due to pain (score more than 4 in Numeric Rating Score from 0 to 10 points) or motor blockade.
Surgical duration	4 hours	Time between skin incision and closure
Readiness to discharge	4 days after surgery	Days to be ready for discharge following physiotherapist criteria
Postoperative static pain at 6 hours after block	6 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 12 hours after block	12 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Block assessment at 24 hours	24 hours after the block	Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.; Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.; Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Incidence of block related adverse events	3 hours after block	Incidence of adverse events related to nerve block (vascular puncture, local anesthetic systemic toxicity, epidural spread)
Incidence of opioid related adverse events	48 hours after block	Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression)
Postoperative static pain at 48 hours after block	48 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points
Postoperative dynamic pain at 48 hours after block	48 hours after the block	Pain evaluated in Numeric Rating Score from 0 to 10 points

Trial Locations

Locations (1)

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Metropolitana, Chile