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Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia

Postoperative Pain in Total Knee Arthroplasty: a Comparison Between General and Spinal Anesthesia

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03176758
Enrollment
60
Registered
2017-06-05
Start date
2017-06-01
Completion date
2018-06-01
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement Surgery

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.

Interventions

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

DRUGGeneral anesthetic

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

DEVICETotal knee replacement

A total knee arthroplasty surgery, which is not the intervention of interest

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain measured by Visual Analogue Scale48 hoursVisual Analogue Scale scores of pain will be documented at different timed during the first 48 postoperative hours

Secondary

MeasureTime frameDescription
Achievements in physical therapy measured by walking distance on the first postoperative day24 hoursThe patient will walk with a walker under the surgeon's supervision, and the surgeon will measure with the distance the succeeded walking

Contacts

Primary Contactdavid segal, MD
dudisegal@gmail.com529423951

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026