A Phase 4 interventional study of Spinal Block and General anesthetic in Total Knee Replacement Surgery, sponsored by Meir Medical Center. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-06-05.
Sponsored by Meir Medical Center · Phase 4, Interventional, and Supportive care
Total knee arthroplasty may be conducted either under general anesthesia or spinal block. previous studies have shown that spinal block leads to less complications. The investigators aim to find whether post-operative pain is also diminished under spinal block compared to general anesthesia
Patients who will be registered for a total knee replacement in Meir Medical Center and that will agree to participate in the study will be enrolled into one of two groups: the first, which will be the default choice for all patients, will be operated under a spinal block. Patients who will ask specifically for general anesthesia, or those in which the anesthesiologist will prefer general anesthesia due to medical reasons will be enrolled into the second group. For both groups the surgeon will add intraoperative peri-articular infiltration of local Marcaine injections, which was previously shown to diminish postoperative pain. The postoperative pain will be evaluated with the Visual Analogue Scale at different point during the first 48 hours following operation. Physiotherapy achievements will also be recorded. The investigators will try to find whether one of the two groups suffered less pain or had achieved better results in physical therapy.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline + Total Knee Replacement ( which will not be the intervention of interest)
Drug: Spinal Block · Device: Total knee replacement
1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg ideal body weight diluted with 100cc Normal Saline + Total Knee Replacement ( which will not be the intervention of interest)
Drug: General anesthetic · Device: Total knee replacement
Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg IBW diluted with 100cc Normal Saline
Also known as: Neurological block
1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg IBW diluted with 100cc Normal Saline
A total knee arthroplasty surgery, which is not the intervention of interest
postoperative pain measured by Visual Analogue Scale
Visual Analogue Scale scores of pain will be documented at different timed during the first 48 postoperative hours
Time frame: 48 hours
Achievements in physical therapy measured by walking distance on the first postoperative day
The patient will walk with a walker under the surgeon's supervision, and the surgeon will measure with the distance the succeeded walking
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: No — Participant's data will be collectively statistically analyzed, The results will be available as part of the researches findings while the participant's information will not be shared.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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