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

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Total Knee Replacement Surgery

Treatments: Device: Total knee replacement; Drug: General anesthetic; Drug: Spinal Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03176758

0094-17-MMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Spinal block

Active Comparator group

Description:

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)

Treatment:

Device: Total knee replacement

Drug: Spinal Block

General anesthesia

Active Comparator group

Description:

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)

Treatment:

Drug: General anesthetic

Device: Total knee replacement