Primary Total Knee Arthroplasty Clinical Trial
Official title:
The Efficacy of Local Infiltration Analgesia for Postoperative Pain Management and Functional Recovery After Total Knee Arthroplasty: Peripheral Nerve Blocks With and Without Local Infiltration Analgesia
NCT number | NCT04258241 |
Other study ID # | BEC-MF-36 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 6, 2020 |
Est. completion date | February 2021 |
This prospective, double-blinded, randomized controlled study evaluates the effects of peripheral nerve blocks with and without local infiltration analgesia for postoperative pain management after primary total knee arthroplasty. There are no any studies that show the demand for local infiltration analgesia when together peripheral nerve blocks are performed. Patients undergoing primary total knee arthroplasty will be randomly assigned to receive local infiltration analgesia with or without (placebo group) local anesthetic. All patients will receive peripheral nerve blocks for postoperative analgesia: femoral triangle and distal adductor canal blocks. Comparison of these two groups of patients will be based on the effects on postoperative pain control, the extent of motor blockade, the ability of early leg motion and ambulation, patients satisfaction rates over the time of clinical recovery. Consequently, the investigators hypothesized that peripheral nerve blocks (femoral triangle and distal adductor canal blocks) with and without local infiltration analgesia provide similar postoperative pain relieving effects and the ability of early mobilization after total knee arthroplasty.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | February 2021 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing primary unilateral total knee arthroplasty under spinal anaesthesia; - Age 18 - 90 years; - Patients conformed to American Society of Anaesthesiologists (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-exiting lower extremity neuromuscular disorders. - Local infection over 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,
Andersen LØ, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17. Review. — View Citation
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
Beswick AD, Dennis J, Gooberman-Hill R, Blom AW, Wylde V. Are perioperative interventions effective in preventing chronic pain after primary total knee replacement? A systematic review. BMJ Open. 2019 Sep 6;9(9):e028093. doi: 10.1136/bmjopen-2018-028093. — View Citation
Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25. Erratum in: J Arthroplasty. 2019 Feb;34(2):399-400. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in postoperative pain intensity and pain control: VAS pain scale | Postoperative pain will be assessed in both groups using the visual analogue scale (VAS). The VAS pain scale (numerical rating scale) consists of a range from 0 (no pain) to 10 (worst imaginable pain). Higher score indicate greater pain intensity. Interpretation: 0 (no pain); 1-3 (mild pain); 4-6 (moderate pain); 7-10 (severe pain). Pain control will be assessed at rest, during active and passive 45 degree knee flexion at 3, 6, 24, 48 hours after the surgery. | First 48 hours after primary total knee arthroplasty. | |
Secondary | Extent of motor blockade. | The extent of postoperative motor blockade and the ability of early motion will be evaluated using the 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 the surgery. | First 48 hours after primary total knee arthroplasty. | |
Secondary | Postoperative ability of early ambulation. | The postoperative ability of early ambulation will be assessed using the Timed Up and Go (TUG) test. The TUG test measures the time it takes the patient to get up from a bed, walk 3 m, turn, walk back to the bed and sit down. The TUG test results will be evaluated at 24 and 48 hours after the surgery. | First 48 hours after primary total knee arthroplasty. | |
Secondary | Opioid consumption. | The need of additional opioid consumption will be recorded at 3, 6, 24 and 48 hours after the surgery in both groups. | First 48 hours after primary total knee arthroplasty. | |
Secondary | Rate of patients satisfaction: 10 point scale | Patients 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 the surgery. | First 48 hours after primary total knee arthroplasty. | |
Secondary | Number of participants with postoperative complications. | The total number of postoperative complications (medication toxicity, falls) will be counted in both groups. | First 48 hours after primary total knee arthroplasty. |
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