Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
THA
Comparison of the Efficacy and Safety of Three Regional Anesthesia Strategies in Patients Undergoing Elective Total Hip Arthroplasty: A Prospective, Randomized, Multicenter Clinical Trial
1 other identifier
interventional
90
1 country
1
Brief Summary
The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty. The main questions this study aims to answer are: Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone. Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation. The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
Study Completion
Last participant's last visit for all outcomes
May 1, 2027
May 13, 2026
February 1, 2026
10 months
March 13, 2026
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Postoperative Opioid Consumption
Total amount of opioids administered postoperatively, expressed as intravenous morphine equivalents.
Up to 48 hours after surgery
Secondary Outcomes (12)
Pain scores at rest
6 hours after surgery
Pain scores durring movement
6 hours after surgery
Pain scores at rest
12 hours after surgery
Pain scores durring movement
12 hours after surgery
Pain scores at rest
24 hours after surgery
- +7 more secondary outcomes
Study Arms (3)
Spinal Anesthesia With Intrathecal Morphine
ACTIVE COMPARATORParticipants will receive spinal anesthesia with intrathecal ropivacaine combined with intrathecal morphine. Ropivacaine 0.5% (10-15 mg) will be administered intrathecally, followed by intrathecal morphine at a dose of 100 micrograms as part of standard anesthesia care.
Spinal Anesthesia Plus PENG Block
EXPERIMENTALParticipants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% administered as a single injection.
Spinal Anesthesia Plus PENG Block With Dexamethasone
EXPERIMENTALParticipants will receive spinal anesthesia with intrathecal ropivacaine 0.5% (10-15 mg) combined with an ultrasound-guided pericapsular nerve group (PENG) block. The PENG block will be performed using 20 mL of ropivacaine 0.2% with the addition of dexamethasone 4 mg administered perineurally as a single injection.
Interventions
Intrathecal morphine administered as part of spinal anesthesia for postoperative pain control during elective total hip arthroplasty.
Ultrasound-guided pericapsular nerve group block performed as an adjunct to spinal anesthesia to provide postoperative analgesia.
Perineural dexamethasone administered as an adjuvant to the pericapsular nerve group block to prolong postoperative analgesia.
Eligibility Criteria
You may qualify if:
- Adults aged 60 to 100 years
- Scheduled for elective total hip arthroplasty
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study procedures and provide written informed consent
You may not qualify if:
- Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone
- Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks
- Infection at the site of spinal or peripheral nerve block injection
- Pre-existing neurological disorders affecting sensory or motor function
- Severe hepatic or renal insufficiency
- Chronic opioid use for more than 3 months prior to surgery
- Refusal or inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznan University of Medical Sciences
Poznan, 62-701, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Malgorzata Reysner, MD PhD
Poznań University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2026
First Posted
May 13, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 13, 2026
Record last verified: 2026-02