Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty
Sponsor:
Ufuk University
Collaborators:
Information provided by (Responsible Party):
Baturay Kansu Kazbek，Ufuk University
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | October 2, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | November 1, 2018 | ||
| Estimated Primary Completion Date | December 1, 2018 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Visual Analogue Score[ Time Frame: T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours ] measurement of postoperative pain using Visual Analogue Score. Minimum: 0 Maximum: 10. Higher values represent more pain, hence lower values are better |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty |
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| Official Title ICMJE | The Effect of Magnesium Sulfate Added to Levobupivacaine in Continous Femoral Block on Analgesic Requirements Following Total Knee Arthroplasty |
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| Brief Summary | This study is designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block following total knee arthroplasty. |
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| Detailed Description | Pain after knee arthroplasty is a serious concern. This study was designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block on analgesic requirements following total knee arthroplasty. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: randomized, controlled, prospective Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
60 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 15, 2018 | ||
| Estimated Primary Completion Date | December 1, 2018 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - scheduled for elective unilateral primary total knee arthroplasty Exclusion Criteria: - Patient refusal to enroll in the study - Patient refusal of neuraxial anesthesia - Existence of contraindications for neuraxial anesthesia - Known history of allergy to any of the study drugs | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Turkey | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Baturay Kansu Kazbek，Ufuk University | ||
| Study Sponsor ICMJE | Ufuk University | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Ufuk University | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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