Clinical trial NCT03176758: Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia
Official title: Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Total Knee Replacement Surgery
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participant will be non-randomly enrolled into two groups. The default treatment, which was found as the preferred method by numerous investigators will be offered to all participants. Those who will ask for the second option (general anesthesia) or those who will not be aligble for spinlal block will be enrolled in the second group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* all patient who will undergo total knee arthroplasty

Exclusion Criteria:

* patients who will not agree to participate in the study
* patients who will die during the research timeframe

Primary outcomes:
measure: postoperative pain measured by Visual Analogue Scale
timeFrame: 48 hours
Secondary outcomes:
measure: Achievements in physical therapy measured by walking distance on the first postoperative day
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Turnbull ZA, Sastow D, Giambrone GP, Tedore T. Anesthesia for the patient undergoing total knee replacement: current status and future prospects. Local Reg Anesth. 2017 Mar 8;10:1-7. doi: 10.2147/LRA.S101373. eCollection 2017.
citation: Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
citation: Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
citation: Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.
citation: Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
citation: Memtsoudis SG, Sun X, Chiu YL, Stundner O, Liu SS, Banerjee S, Mazumdar M, Sharrock NE. Perioperative comparative effectiveness of anesthetic technique in orthopedic patients. Anesthesiology. 2013 May;118(5):1046-58. doi: 10.1097/ALN.0b013e318286061d.