Hip Osteoarthritis, Pain, Acute, Pain, Postoperative, Opioid Use
Conditions
Keywords
nerve block, fascia iliaca, hip replacement, lumbar plexus
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.
Interventions
PROCEDURElumbar plexus block
Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, in the posteromedial quadrant of psoas muscle
PROCEDUREsuprainguinal fascia iliaca block
Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, underneath the fascia iliaca at the suprainguinal level
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption over 24 hours | 24 hours post block | Total morphine consumption over 24 hours post block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 6 hours after block | 6 hours after the block | Pain evaluated in Numeric Rating Score from 0 to 10 points |
| Performance time | 2 hours after surgery | Interval between the start of skin disinfection and the end of local anesthetic injection |
| 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 static 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 12 hours after block | 12 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 |
| 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 static 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. |
| 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. |
| 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) |
| 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 |
| Length of hospital stay | 7 days after surgery | Length of hospital stay after surgery |
| Postoperative dynamic pain at 48 hours after block | 48 hours after the block | Pain evaluated in Numeric Rating Score from 0 to 10 points |
Countries
Chile
Outcome results
None listed