Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty
1 other identifier
interventional
90
1 country
2
Brief Summary
To compare the different analgesic protocols for patients receiving total hip arthroplasty(THA). Patients will divided into 3 groups, which are 1. fascia iliaca compartment block with IV-PCA(patient controlled analgesia), 2. femoral nerve and lateral femoral cutaneous nerve block with IV-PCA, 3. IV-PCA only.
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 Jul 2017
Shorter than P25 for not_applicable
2 active sites
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
June 22, 2017
CompletedFirst Posted
Study publicly available on registry
July 27, 2017
CompletedStudy Start
First participant enrolled
July 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2018
CompletedJuly 27, 2017
July 1, 2017
9 months
June 22, 2017
July 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Temporal changes of Pain score
Pain score by numerical rating scale from pre-intervention to 24 hours after intervention(the effect of neural blockade seldom lasts more than 24 hours)
1. Pre-intervention(which is the time when operation was done and the patient arrive postoperative care unit.) 2. 30 minutes after intervention, 3. 60 minutes after intervention, 4. 120 minutes after intervention, 5. 24 hours after intervention.
Secondary Outcomes (3)
Opioid consumptions
postoperatively 24 hours
Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area
1 hour post-intervention
NSAID consumptions
24 hours postoperatively
Study Arms (3)
fascia iliaca compartment block+ IV-PCA
ACTIVE COMPARATORfemoral nerve and lateral femoral cutaneous nerve block+IV PCA
ACTIVE COMPARATORIV PCA only
PLACEBO COMPARATORInterventions
1\. Fascia iliaca compartment block: The injection was performed under ultrasound guidance. Surface landmark is identified on the line between anterior superior iliac spine and pubic tubercle. The injection site is at the medial one-third of the line. The needle is threaded medial to lateral and standardization of local anesthetic deposit is in the fascia plane between fascia iliaca and iliacus muscle. Anesthetic regimen: 2% xylocaine 15mL + 0.5% bupivacaine 15mL.
1. Femoral nerve block: The injection was performed under ultrasound guidance. Femoral nerve was identified in the femoral neurovascular bundle below or around inguinal ligament. The needle is threaded with lateral to medial approach. Local anesthetics will be deposited around the femoral nerve, the standardization of protocol is that femoral nerve should be lifted off from iliacus muscle. Anesthetic regimen: 2% xylocaine 10mL + 0.5% bupivacaine 10mL. 2. Lateral femoral cutaneous nerve block: The injection was performed under ultrasound guidance. Lateral femoral cutaneous nerve was identified in the fascia plane between sartorius muscle and tensor fascia lata muscle. Anesthetic regimen: 2% xylocaine 5mL + 0.5% bupivacaine 5mL
IV-PCA was programmed and provided to the patient for optimize pain control
Eligibility Criteria
You may qualify if:
- ASA I-III, general anesthesia with intubation.
- fentanyl IV PCA
You may not qualify if:
- Alcohol/substance abuse
- Rheumatoid arthritis
- Severe coagulation disorder(PLT\<80000 or INR \> 1.5)
- Peripheral neuropathy
- Allergy to opioids or local anesthetics
- BMI\>35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Dept. of Anesthesiology, Taichung Veterans General Hospital
Taichung, Taiwan
Related Publications (1)
1. Hadzic's peripheral nerve blocks and anatomy for ultrasound-guidedregional anesthesia, 2012. Chapter.35, 36. 2. K.H. Thymo, O. Mathiesen, J.B. Dahl, et al. Lateral femoral cutaneous nerve block after total hip arthroplasty: a randomized trial. Acta Anaesthesiologica Scandinavica 60(2016) 1297-1305. 3. Shoji Nishio, Shigeo Fukunishi, Miura Juichi et al. Comparison of continuous femoral nerve block, caudal epidural block, and intravenous patient-controlled analgesia in pain control after total hip arthroplasty: a prospective randomized study. Orthopedic Reviews 2014; 6; 5138. 4. Bin Yu, Miao He, Guang-Yu Cai et al. Ultrasound-guided continuous femoral nerve block vs continuous fascia iliaca compartment block for hip replacement in the elderly. Medicine (2016) 95:42 5. Guay J, Parker MJ, Gajendragadkar PR, et al. Anaesthesia for hip fracture surgery in adults. Cochrane Database of Systemic Reviews 2016, issue 2, Art. No:CD000521. 6. K.H. Thybo, Harald Schmidt and Daniel Hagi-Pederson. Effect of lateral femoral cutaneous nerve block on pain after total hip arthroplasty: a randomized , blinded, placebo-controlled trail. BMC anesthesiology (2016) 16:21. 7. John Dolan, Anne Williams, Eileen Murney, et al. Ultrasound guided fascial iliaca block: a comparison with loss of resistance technique. Reg Anesth Pain Med 2008; 33: 526-31 8. Ali N. Shariat, Admir Hadzic, Daquan Xu, et al. Fascia iliaca block for analgesia after hip arthroplasty: a randomized double-blinded, placebo-controlled trial. Reg Anesth Pain Med 2013;38:201-205
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yi-Ting Chang, M.D.
Taichung Veterans General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2017
First Posted
July 27, 2017
Study Start
July 27, 2017
Primary Completion
April 19, 2018
Study Completion
April 19, 2018
Last Updated
July 27, 2017
Record last verified: 2017-07