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

Sponsor
Taichung Veterans General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03231319
Collaborator
(none)
90
Enrollment
2
Locations
3
Arms
8.7
Anticipated Duration (Months)
45
Patients Per Site
5.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fascia iliaca compartment block with IV-PCA
  • Procedure: Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA
  • Procedure: IV-PCA
 N/A

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.

  1. 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

  2. The outcome followers are blinded to the intervention provided.

  3. Outcome parameters:

  4. Opioid consumption of IV PCA in first 24 hrs.

  5. NSAID consumption

  6. 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

  1. sensory block in FN, Obturator Nerve and LFCN

  2. First request of supplemental IV analgesia

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty
Anticipated Study Start Date :
Jul 27, 2017
Anticipated Primary Completion Date :
Apr 19, 2018
Anticipated Study Completion Date :
Apr 19, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: fascia iliaca compartment block+ IV-PCA

Procedure: 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.
Active Comparator: femoral nerve and lateral femoral cutaneous nerve block+IV PCA

Procedure: Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA
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
Placebo Comparator: IV PCA only

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

Outcome Measures

Primary Outcome Measures

  1. Temporal changes of Pain score [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.]

    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

  1. Opioid consumptions [postoperatively 24 hours]

    Including IV-PCA and other analgesics

  2. Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area [1 hour post-intervention]

  3. NSAID consumptions [24 hours postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taichung Veterans General Hospital Taichung Taiwan 40705
2 Dept. of Anesthesiology, Taichung Veterans General Hospital Taichung Taiwan

Sponsors and Collaborators

  • Taichung Veterans General Hospital

Investigators

  • Study Chair: Yi-Ting Chang, M.D., Taichung Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT03231319
Other Study ID Numbers:
  • CF17089A
First Posted:
Jul 27, 2017
Last Update Posted:
Jul 27, 2017
Last Verified:
Jul 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Jul 27, 2017