Clinical trial
The Efficacy of Combined Intrathecal Morphine and Pericapsular Nerve Group (PENG) Block on Postoperative Pain and Recovery Quality in Anterior Hip Arthroplasty: A Prospective, Double-blind, Randomized Clinical Trial
Name
PENG study
Description
This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone.
Trial arms
Trial start
2024-03-18
Estimated PCD
2024-06-08
Trial end
2024-07-08
Status
Recruiting
Treatment
Pericapsular nerve group block plus intrathecal bupivacaine
Patients will undergo ultrasound-guided block using a linear or convex ultrasound probe in the supine position before intrathecal bupivacaine. The block procedure will involve the use of a local anesthetic solution (10-20 ml of 0.25% bupivacaine and 2 mg dexamethasone) and a 22 Gauche 80 mm block needle. Subsequently, intrathecal bupivacaine will be administered at the L3-L4 intervertebral level with 10-15 mg bupivacaine while the patient is in a sitting position.The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.
Arms:
Group P
Other names:
Spinal anesthesia, Peripheric nerve block
Intrathecal bupivacaine and morphine
Patients will receive intrathecal bupivacaine and morphine without Pericapsular Nerve Group block. Intrathecal drugs will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 μg of morphine. The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.
Arms:
Group M
Other names:
Spinal anesthesia
Pericapsular nerve group block plus intrathecal bupivacaine and morphine
Patients will undergo ultrasound-guided block using a linear or convex ultrasound probe in the supine position before intrathecal drugs. The block procedure will involve the use of a local anesthetic solution (10-20 ml of 0.25% bupivacaine and 2 mg dexamethasone) and a S22 Gauche 80 mm block needle. Subarachnoid block will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 μg of morphine. The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.
Arms:
Group P+M
Other names:
Spinal anesthesia, Peripheric nerve block
Size
3
Primary endpoint
Morphine consumption
From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours
Eligibility criteria
Inclusion Criteria:
* Aged between 18 and 90 years
* American Society of Anesthesiologists (score ranging from 1 to 4)
* Anterior hip arthroplasties
Exclusion Criteria:
* Patients with a history of opioid addiction
* Individuals under the age of 18
* Those aged 90 and above
* Allergies to morphine, fentanyl, bupivacaine, or tramadol
* Coagulopathy
* Infection at the injection site
* Severe cardiac, renal, or hepatic dysfunction
* Cases unable to provide informed consent
* Body Mass Index \>40 kg/m2
* Known neurological or anatomical deficits in the lower extremities
* Patients requiring a transition from spinal anesthesia to general anesthesia
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, double-blind, randomized clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 3, 'type': 'ESTIMATED'}}
Updated at
2024-03-07
1 organization
3 products
1 indication
Organization
Bezmialem Vakif UniversityIndication
Postoperative Pain Management