Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty

NCT ID: NCT03231319

Last Updated: 2017-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-27

Study Completion Date

2018-04-19

Brief Summary

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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

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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

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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fascia iliaca compartment block+ IV-PCA

Group Type ACTIVE_COMPARATOR

Fascia iliaca compartment block with IV-PCA

Intervention Type PROCEDURE

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.

femoral nerve and lateral femoral cutaneous nerve block+IV PCA

Group Type ACTIVE_COMPARATOR

Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA

Intervention Type PROCEDURE

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 only

Group Type PLACEBO_COMPARATOR

IV-PCA

Intervention Type PROCEDURE

IV-PCA was programmed and provided to the patient for optimize pain control

Interventions

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Fascia iliaca compartment block with IV-PCA

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.

Intervention Type PROCEDURE

Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA

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

Intervention Type PROCEDURE

IV-PCA

IV-PCA was programmed and provided to the patient for optimize pain control

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi-Ting Chang, M.D.

Role: STUDY_CHAIR

Taichung Veterans General Hospital

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Dept. of Anesthesiology, Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tsung-Yung Tang, M.D.

Role: CONTACT

+886975351575

Chih-Cheng Wu, M.D.

Role: CONTACT

+886975358990

Facility Contacts

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Tsung-Yung Tang, M.D.

Role: primary

+886423592525 ext. 4108

Tsung-Yung Tang, M.D.

Role: primary

+886423592525 ext. 4108

References

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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

Reference Type BACKGROUND

Other Identifiers

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CF17089A

Identifier Type: -

Identifier Source: org_study_id

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