University Hospital of Lausanne
Lausanne, Canton of Vaud, 1011, Switzerland
Location status: Recruiting
Location contact
Corey Kull
CONTACT
Marta Szyszko du Bois d'Aische
CONTACT
NCT Number: NCT06317870
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Lausanne, Canton of Vaud, 1011, Switzerland
Location status: Recruiting
Corey Kull
CONTACT
Marta Szyszko du Bois d'Aische
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 hours postoperatively
total consumption in mg
Time frame: from admission till discharge from the recovery room, up to 2 hours
consumption in mg
Time frame: at day 2 postoperatively
consumption in mg administered by PCA
Time frame: at 2 hours, day 1 and day 2 postoperatively
Visual Analogue Scale(VAS), 0-10
Time frame: at 2 hours, day 1 and day 2 postoperatively
Presence of nausea or vomiting in the postoperative period
Time frame: at 2 hours, day 1 and day 2 postoperatively
Presence of pruritus in the postoperative period
Time frame: from surgery till day 2 postoperatively
Urinary retention requiring catheterisation
Time frame: 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
Time frame: at day 1 and day 2 postoperatively
Medical Research Council Manual Muscle Testing scale, 0-5
Time frame: at day 1 and 2 postoperatively
maximum distance travelled (meters)
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire Vaudois
Other
Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty: a Double Blind, Non-inferiority Study
Acronym: PENGIT
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