Analgesia Clinical Trial
Official title:
Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty: a Double Blind, Non-inferiority Study
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.
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 and 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05534230 -
Dexmedetomidine for Pain Reduction in CABG
|
N/A | |
Recruiting |
NCT06275698 -
HONEY for the Treatment of POst-Tonsillectomy Pain
|
N/A | |
Recruiting |
NCT04436224 -
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
|
Phase 4 | |
Not yet recruiting |
NCT04548323 -
Hypoalgesic Effects of Walking and Running Imagined
|
||
Completed |
NCT06054945 -
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
|
||
Completed |
NCT04394481 -
Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery
|
Phase 4 | |
Completed |
NCT04690647 -
The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
|
N/A | |
Completed |
NCT05034601 -
ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
|
N/A | |
Completed |
NCT03740815 -
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection
|
N/A | |
Recruiting |
NCT05454202 -
Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
|
||
Recruiting |
NCT04554186 -
Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.
|
N/A | |
Suspended |
NCT04860635 -
Safety of F14 Following Total Knee Replacement
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06393777 -
Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion
|
N/A | |
Not yet recruiting |
NCT04519463 -
The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing
|
Early Phase 1 | |
Completed |
NCT02916342 -
Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks
|
Phase 4 | |
Completed |
NCT03206554 -
Local Infiltration Analgesia in Total Knee Arthroplasty
|
Phase 2 | |
Not yet recruiting |
NCT02549118 -
Tenoxicam for Intrapartum Analgesia
|
Phase 2 | |
Not yet recruiting |
NCT02190760 -
Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.
|
N/A | |
Completed |
NCT01789606 -
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
|
Phase 3 | |
Completed |
NCT01299584 -
ULTIVA Post Marketing Surveillance
|
N/A |