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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fascia iliaca compartment block with IV-PCA
Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA
IV-PCA
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taichung Veterans General HospitalRecruiting
  • Dept. of Anesthesiology, Taichung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

fascia iliaca compartment block+ IV-PCA

femoral nerve and lateral femoral cutaneous nerve block+IV PCA

IV PCA only

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Opioid consumptions
Including IV-PCA and other analgesics
Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area
NSAID consumptions

Full Information

First Posted
June 22, 2017
Last Updated
July 25, 2017
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03231319
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 27, 2017 (Anticipated)
Primary Completion Date
April 19, 2018 (Anticipated)
Study Completion Date
April 19, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. Inclusion criteria: Patient undergoing THA: 20-75 years old, 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 The outcome followers are blinded to the intervention provided. Outcome parameters: Opioid consumption of IV PCA in first 24 hrs. NSAID consumption 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 sensory block in FN, Obturator Nerve and LFCN First request of supplemental IV analgesia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fascia iliaca compartment block+ IV-PCA
Arm Type
Active Comparator
Arm Title
femoral nerve and lateral femoral cutaneous nerve block+IV PCA
Arm Type
Active Comparator
Arm Title
IV PCA only
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment block with IV-PCA
Intervention Description
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
Intervention Name(s)
Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA
Intervention Description
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. 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
Intervention Name(s)
IV-PCA
Intervention Description
IV-PCA was programmed and provided to the patient for optimize pain control
Primary Outcome Measure Information:
Title
Temporal changes of Pain score
Description
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)
Time Frame
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 Outcome Measure Information:
Title
Opioid consumptions
Description
Including IV-PCA and other analgesics
Time Frame
postoperatively 24 hours
Title
Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area
Time Frame
1 hour post-intervention
Title
NSAID consumptions
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsung-Yung Tang, M.D.
Phone
+886975351575
Email
b92401096@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Cheng Wu, M.D.
Phone
+886975358990
Email
chihcheng.wu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Ting Chang, M.D.
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsung-Yung Tang, M.D.
Phone
+886423592525
Ext
4108
Email
b92401096@gmail.com
Facility Name
Dept. of Anesthesiology, Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsung-Yung Tang, M.D.
Phone
+886423592525
Ext
4108
Email
b92401096@gmail.com

12. IPD Sharing Statement

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

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