Analgesia, Hip Arthropathy, Post Operative Pain
Conditions
Keywords
nerve block, intrathecal morphine, postoperative pain, hip arthroplasty
Brief summary
The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain. Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding.
Detailed description
The aim of this double-blind, non-inferiority study is to compare the analgesic effect of a PENG block with intrathecal morphine in patients scheduled for total hip arthroplasty. Postoperative morphine consumption and pain scores, morphine-related adverse effects and functional parameters will be compared between two groups. The investigators believe that PENG block provides postoperative analgesia equivalent to intrathecal morphine. The research team plans to enrol 80 patients and randomise them to two groups - pericapsular nerve block (PENG) or intrathecal morphine (ITM). After written informed consent, patients will be allocated to one of the two groups according to a computer-generated randomisation list. The PENG group will receive central spinal anaesthesia with 12.5 mg isobaric bupivacaine followed by a PENG block with 20 cc of 0.75% ropivacaine. ITM groups will receive central spinal anaesthesia with 12.5 mg isobaric bupivacaine and 100 mcg morphine followed by a sham PENG block. During the surgery, 0.15 mg/kg of dexamethasone iv, 1g acetaminophen iv, 30mg ketorolac iv and 40mg/kg magnesium iv will be administered for post operative analgesia. In the post-operative care unit, pain management will be provided with as needed with 2mg of IV morphine at ten minute intervals for pain scores \>3. Once spinal motor block has ceded, the patients will be transferred to the surgical ward with a morphine patient controlled analgesia (PCA) pump. The pump parameters will allow 2 mg boluses of morphine with a 10-minute lockout and a maximum dose of 40 mg in 4 hours. Basal analgesia will be provided with paracetamol (1g/6h) and ibuprofen (400mg/8h). Ondansetron (4mg IV) will be provided in case of nausea or vomiting. A research assistant will conduct post operative visits at 2h, 1 day and 2 days post-operatively to record research data. Functional testing will be performed at day 1 and 2 by physiotherapy personnel.
Interventions
PROCEDUREIntrathecal morphine
Spinal anesthesia will be performed as follows: patient will be placed in the lateral decubitus position on the non-operative side. Using sterile gloves red chlorhexidine 2% alcohol solution will be used for skin disinfection. The site will be secured with a sterile drape, and the L4-L5 lumbar space identified. After subcutaneous local infiltration with 1% lidocaine, a 25G Whitacre pencil point spinal needle will be used to access the intrathecal space with free flow of cerebrospinal fluid as confirmation. A mixture of 12.5 mg of isobaric bupivacaine and 100 mcg of morphine will be administered intrathecally. After the spinal anesthesia, the intrathecal morphine (ITM) group will receive a sham PENG block with the block needle inserted subcutaneously, the anesthesiologist using the same verbal block confirmation commands aspirate, inject but the needle withdrawn without injection. This will create the appearance of an identical cutaneous injection site to ensure patient blinding.
Spinal anesthesia with intrathecal injection of 12.5 mg of isobaric bupivacaine will be performed, followed by a PENG block. After skin disinfection, a low frequency curvilinear ultrasound probe (2-5 MHz 8870, BK ultrasound, Peabody Massachussets, US) with a sterile covering will be used to identify the anterior inferior iliac spine, the pubic eminence and the psoas tendon with its fascial plane. A 22 gauge 10cm block needle (Sonoplex® Pajunk, Geisingen, DE), will be used to enter the fascial plane and 20ml of 0.75% Ropivacain (Fresenius Kabi, Krienz CH) will be injected.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
quadruple
Intervention model description
single centered, prospective, double blinded non inferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients * ASA (American Society of Anaesthesiologists) I-III * 18 years of age or older * Patients scheduled for elective primary hip arthroplasty * Able to give written conformed consent autonomously
Exclusion criteria
* Refusal or inability to give consent * Allergy to any of: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone * Bleeding diathesis * Neurological deficit of the operative side * Existing preoperative opioid use * Renal insufficiency (GFR\<30ml/min according to the Cockroft-Gault formula) * Hepatic insufficiency * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative postoperative morphine consumption at day 1 | 24 hours postoperatively | total consumption in mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCA administered morphine consumption at day 2 | at day 2 postoperatively | consumption in mg administered by PCA |
| rest and dynamic pain scores | at 2 hours, day 1 and day 2 postoperatively | Visual Analogue Scale(VAS), 0-10 |
| Incidence of postoperative nausea and vomiting | at 2 hours, day 1 and day 2 postoperatively | Presence of nausea or vomiting in the postoperative period |
| Incidence of pruritus | at 2 hours, day 1 and day 2 postoperatively | Presence of pruritus in the postoperative period |
| Morphine consumption in the recovery room | from admission till discharge from the recovery room, up to 2 hours | consumption in mg |
| Duration of analgesia | from the time the study procedure is performed up to 36 hours after surgery | Time between study procedure and the first dose of iv morphine |
| operated limb quadriceps strength | at day 1 and day 2 postoperatively | Medical Research Council Manual Muscle Testing scale, 0-5 |
| Walking test | at day 1 and 2 postoperatively | maximum distance travelled (meters) |
| Incidence of urinary retention requiring bladder catheterisation | from surgery till day 2 postoperatively | Urinary retention requiring catheterisation |
Countries
Switzerland
Contacts
Primary ContactEric Albrecht, Prof
Outcome results
None listed