Clinical trial NCT03231319: Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty
Official title: Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 90 patients will be enrolled and randomized to the 3 different groups.

1. Inclusion criteria:

   Patient undergoing THA: 20-75 years old, ASA I-III, general anesthesia with intubation, fentanyl IV PCA.
2. Exclusion criteria Alcohol/substance abuse Rheumatoid arthritis Severe coagulation disorder(PLT\<80000 or INR \> 1.5) Peripheral neuropathy Allergy to opioids or local anesthetics BMI\>35
3. The outcome followers are blinded to the intervention provided.
4. Outcome parameters:

   1. Opioid consumption of IV PCA in first 24 hrs.
   2. NSAID consumption
   3. NRS of pain, the timings of follow-up should be: pre-block, 30

      mins post-block, 60 mins post-block, 2 hours post-block, 24hours post-block
   4. sensory block in FN, Obturator Nerve and LFCN
   5. First request of supplemental IV analgesia

Eligibility criteria: Inclusion Criteria:

* ASA I-III, general anesthesia with intubation.
* fentanyl IV PCA

Exclusion Criteria:

* Alcohol/substance abuse
* Rheumatoid arthritis
* Severe coagulation disorder(PLT\<80000 or INR \> 1.5)
* Peripheral neuropathy
* Allergy to opioids or local anesthetics
* BMI\>35

Primary outcomes:
measure: Temporal changes of Pain score
timeFrame: 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:
measure: Opioid consumptions
timeFrame: postoperatively 24 hours
measure: Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area
timeFrame: 1 hour post-intervention
measure: NSAID consumptions
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Dept. of Anesthesiology, Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Yi-Ting Chang, M.D.
role: STUDY_CHAIR
References:
citation: 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