Total Knee Arthroplasty Clinical Trial
Official title:
Femoral Triangle and Adductor Canal Blocks Versus Femoral Nerve Block for Total Knee Arthroplasty: Postoperative Pain Management and Functional Recovery
NCT number | NCT03645954 |
Other study ID # | BEC-MF-172 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 28, 2018 |
Est. completion date | May 31, 2019 |
Verified date | January 2021 |
Source | Lithuanian University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective, double-blinded, randomized controlled study evaluates effects of femoral triangle and adductor canal blocks in comparison with femoral nerve block for primary total knee arthroplasty. Patients undergoing primary total knee arthroplasty will be randomly assigned to receive either femoral triangle and adductor canal blocks or femoral nerve block. Comparison of these two groups of patients will be based on the effects on postoperative pain control, extent of motor blockade, ability of early ambulation, patients satisfaction rates over the time of clinical recovery and the length of hospitalization. To the investigator's knowledge, no comparison has been made between femoral triangle and adductor canal blocks and femoral nerve block or any other block. Consequently, we hypothesized that femoral triangle and adductor canal blocks and femoral nerve block provide similar effects on postoperative pain control, but femoral triangle and adductor canal blocks are superior to femoral nerve block in terms of early postoperative mobilization.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients undergoing primary unilateral total knee arthroplasty under the spinal anesthesia. - Age 18 - 90 years. - Patients conformed to American Society of Anesthesiologists (ASA) physical status I-III in preoperative assessment. - Ability to follow the study protocol. Exclusion Criteria: - Inability or refusal to follow the study protocol. - American Society of Anesthesiologists (ASA) physical status classification of IV or higher. - Coagulopathy. - Pre-existing lower extremity neuromuscular disorders. - Local infection over the injection site. - Allergy or contraindications to the drugs used in the study (local anesthetics, NSAIDs, opioids). - Chronic opioid use. - Other type of anesthesia. |
Country | Name | City | State |
---|---|---|---|
Lithuania | Lithuanian University of Health Sciences Kauno Klinikos, Department of Anesthesiology | Kaunas |
Lead Sponsor | Collaborator |
---|---|
Lithuanian University of Health Sciences |
Lithuania,
Bendtsen TF, Moriggl B, Chan V, Børglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. — View Citation
Dong CC, Dong SL, He FC. Comparison of Adductor Canal Block and Femoral Nerve Block for Postoperative Pain in Total Knee Arthroplasty: A Systematic Review and Meta-analysis. Medicine (Baltimore). 2016 Mar;95(12):e2983. doi: 10.1097/MD.0000000000002983. Review. — View Citation
Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8. — View Citation
Koh IJ, Choi YJ, Kim MS, Koh HJ, Kang MS, In Y. Femoral Nerve Block versus Adductor Canal Block for Analgesia after Total Knee Arthroplasty. Knee Surg Relat Res. 2017 Jun 1;29(2):87-95. doi: 10.5792/ksrr.16.039. Review. — View Citation
Kuang MJ, Ma JX, Fu L, He WW, Zhao J, Ma XL. Is Adductor Canal Block Better Than Femoral Nerve Block in Primary Total Knee Arthroplasty? A GRADE Analysis of the Evidence Through a Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Oct;32(10):3238-3248.e3. doi: 10.1016/j.arth.2017.05.015. Epub 2017 May 17. Review. — View Citation
Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extent of Motor Blockade | The extent of postoperative motor blockade will be evaluated using Bromage scale: Grade I - free movement of legs and feet, Grade II - just able to flex knees with free movement of feet, Grade III - unable to flex knees, but with free movement of feet, Grade IV - unable to move legs or feet. It will be assessed at 3, 6, 24, 48 hours after surgery. | 3, 6, 24, 48 hours after primary total knee arthroplasty. | |
Primary | Postoperative Pain Intensity and Pain Control | Postoperative pain intensity and pain control will be assessed in both groups using visual analogue scale (VAS). VAS scale is consisted of a scale from 0 (no pain) to 10 (worst imaginable pain). Pain control and pain intensity will be assessed at rest, during active and passive 45 degree knee flexion at 3, 6, 24, 48 hours after surgery. | 3, 6, 24, 48 hours after primary total knee arthroplasty. | |
Secondary | Ability of Early Ambulation After Surgery | Postoperative ability of early ambulation will be assessed using Timed Up and Go (TUG) test. The TUG test measures the time it takes the patient to get up from a bed, walk 3 meters, turn, walk back to the bed and sit down. The TUG test results will be evaluated at 24 and 48 hours after surgery. | 24, 48 hours after primary total knee arthroplasty. | |
Secondary | Number of Participants Needing Additional Opioids | The need of additional opioids will be recorded at 3, 6, 24 and 48 hours after surgery in both groups. | 3, 6, 24, 48 hours after primary total knee arthroplasty. | |
Secondary | Rate of Patients Satisfaction | Patient satisfaction rates will be evaluated using a 10 point scale from 0 (completely unsatisfied) to 10 (totally satisfied) at 3, 6, 24, 48 hours after surgery. | 3, 6, 24, 48 hours after primary total knee arthroplasty. | |
Secondary | Number of Participants With Nausea or Vomiting | The number of patients with nausea and vomiting will be evaluated in both groups of patients. | 3, 6, 24, 48 hours after primary total knee arthroplasty. |
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