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US-guided femoral nerve block is used effectively in post-operative pain management in the surgical treatment of the lower extremity. However, the volume and concentration of the local anesthetic drug to be administered remains controversial. In this prospective, randomized, double-blinded study, patients who underwent unilateral primary total knee arthroplasty and successfully performed spinal anesthesia with standard method and dosage, will be selected for US-guided femoral nerve block after the operation. Patients will be divided into three groups with simple randomization. The First group will be determined as the control group (GCont) and only dressing will be applied to the patients. For second group(G125), 0,125% 20 ml local anesthetic and for the third group (G25), 0,25% 10 ml local anesthetic will be administered to the femoral nerve without changing the drug dose (25 mg bupivacaine). Whether there is a difference between post-op analgesia durations, motor block formation, mobilization time and 90° flexion time between the groups will be investigated.
All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll(1,4: GCont - 2,5: G125 - 3,6: G25). Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group. After successfully completed surgery, patients will be administered femoral nerve block or only dressing according to the relevant group. Before femoral nerve block is performed, patients will be re-informed about Numeric Rating Scale(NRS) and will be asked to rate their pain at the moment.
The procedures will be performed in the operating room under both US and nerve stimulator guidance. Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Scheduled and on-demand(Tramadol) medication for analgesia will be ordered and nurses will be informed about the study. Patients' pain scores and ambulation times will be followed-up by another anesthesiologist and on-demand medication will be recorded and monitored from hospital's computer based hospital management program online. Patients will be followed-up for six months after the surgery in order to explore potential long term benefits and complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCont | Sham Comparator | Only dressing will be applied to patients without actually nerve block performed |
|
| G125 Block | Active Comparator | Ultrasound Guided Femoral Nerve Block: 20ml Bupivacaine 0.125% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 15ml Saline solution. |
|
| G25 Block | Active Comparator | Ultrasound Guided Femoral Nerve Block: 10ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 5ml Saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Guided Femoral Nerve Block | Procedure | Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 30th minute postoperatively |
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 1st hour postoperatively |
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 2nd hour postoperatively |
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 6th hour postoperatively |
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 12th hour postoperatively |
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 24th hour postoperatively |
| Post-operative pain assessed by Numeric Rating Scale (NRS) | Pain scores will be recorded as reported by the patient according to NRS | 48th hour postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulation Time | First time a patients can walk around independently | 72 hours post-operatively |
| Opioid Consumption | Opioids(Tramadol) will be administered to patients in case demanded. |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Infection | Surgery site or prosthesis infection in six months following surgery | Six months post-operatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeki T TEKGUL, Associate Professor | Izmir Bozyaka Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Bozyaka Training and Research Hospital | Karabağlar | İzmir | 35170 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28273133 | Background | Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017. | |
| 28971169 | Background | Tulgar S, Selvi O, Senturk O, Serifsoy TE, Sanel S, Meydaneri S. Evaluation of analgesic regimens in total knee arthroplasty, retrospective study. North Clin Istanb. 2017 Aug 25;4(2):124-130. doi: 10.14744/nci.2017.88598. eCollection 2017. |
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Three groups involved. One control group and two nerve block groups with different drug concentration
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|
| Dressing | Other | Only dressing will be applied to related area to protect blindness between groups |
|
| Bupivacaine 0.25% Injectable Solution | Drug | Perineural Injection |
|
|
| Bupivacaine 0.125% Injectable Solution | Drug | Perineural Injection |
|
|
| 48 hour post-operatively |
| 29026354 | Background | Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D001458 | Bandages |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D004864 | Equipment and Supplies |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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