Perioperative analgesia for elective total hip arthroplasty
Perioperative analgesia for elective total hip arthroplasty under subarachnoid anesthesia with opioids: comparison between epidural, femoral nerve block, FICB (fascia iliaca compartment block), femorocutaneous nerve block and psoas block techniques.
Hospital Complex of Navarra (Complejo Hospitalario de Navarra)
500 participants
Oct 1, 2018
Interventional
Conditions
Summary
Analgesia in total hip arthroplasty is important to reduce the incidence of postoperative chronic pain. This prospective, randomized trial compares several regional alternatives to subarachnoid anaesthesia (the most common technique). All of these interventions are widely used in routine clinical practice to improve analgesia, but there is not enough data to establish which of them is the most adequate to treat pain.
Eligibility
Inclusion Criteria1
- Patients scheduled for total hip arthroplasty
Exclusion Criteria1
- unicompartmental hip arthroplasty, refusal to participate, contraindication to spinal or regional anesthesia and/or allergy to the drugs used
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients scheduled for total hip arthroplasty under spinal anesthesia enrolled during preoperative anesthesia consultation. Written informed consent obtained from all patients willing to participate in this study. All patients will receive subarachnoid anesthesia in the sitting position at L3–4 or L4–5 interspace, with a 25-gauge Whitacre needle. We administer 0.5% hyperbaric bupivacaine (Hyperbaric bupivacaine 0.5% 'Registered Trademark', Braun) according to the following formula: bupivacaine (mg) = height (cm) x 0.07, with morphine (Morphine 0.1% 'Registered Trademark',, Braun) 0.15 mg and fentanyl (Fentanest 'Registered Trademark', Kern Pharma) 15 microg. Following injection, patients are immediately kept on lateral decubitus for 6 minutes to improve analgesia. There are 10 groups: - control group (without additional blocks). - epidural analgesia group (the subarachnoid anesthesia in these patients will be performed through the epidural needle at L3-4 or L4-5, the catheter advanced 3-4 cm and levobupivacaine (Chirocane 'Registered Trademark', Abbvie) 0.1% + fentanyl 2 microg.mL-1 (infusion rate 6-10 mL.h-1, bolus volume 5 mL, lock interval 30 min). Epidural infusion is started at the end of surgery. - femoral nerve block with 20 ml of levobupivacaine 0.375%, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - femoral block with 20 ml of levobupivacaine 0.375% and dexamethasone (Fortecortin 'Registered Trademark', Merck) 4 mg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - Fascia Iliaca Compartment Block with 20 ml of levobupivacaine 0.375%, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - Fascia Iliaca Compartment Block with 20 ml of levobupivacaine 0.375% and dexamethasone 4 mg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - Femorocutaneous nerve block with 10 ml of levobupivacaine 0.375%, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - Femorocutaneous nerve block with 20 ml of levobupivacaine 0.375% and dexamethasone 4 mg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - Psoas block with 20 ml of levobupivacaine 0.375%, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. - Psoas block with 20 ml of levobupivacaine 0.375% and dexamethasone 4 mg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again. Surgeons and anesthesiologists are blinded to the addition of dexamethasone (perineural medication is prepared by a nurse adding 4 mg of dexamethasone or 1 ml of saline according to the randomized protocol). Nerve blocks are single-shots techniques performed under both ultrasound and nerve stimulation (considered adequate at 0.2-0.5 mA) by experienced anesthesiologists. All patients receive a standardized postoperative IV treatment: metamizole magnesium 8g/24 h, dexketoprofen 50 mg/12h. Postoperative analgesia begins immediately at the end of the surgery, when the patient is admitted to the PACU. The primary outcome, pain, is measured every hour (respecting the sleep period) during 24 h using a verbal rating 11–point scale for patient self-reporting of pain (VRS-11) previously explained to the patients: from 0 (“no pain”) to 10 (“the most horrible pain you can imagine; such as being burned alive”), and they are also advised to notify their nurse if they feel pain. Rescue analgesia when needed include: 1st: paracetamol 1 g, maximum 1g/6h/IV 2nd: Morphine 2 mg/15 min, maximum 10 mg/4h/IV Rescue blocks: FICB and epidural
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12618001474246