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Clinical Trials/NCT03176758
NCT03176758
Unknown
Phase 4

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

Meir Medical Center0 sites60 target enrollmentJune 1, 2017

Overview

Phase
Phase 4
Intervention
Spinal Block
Conditions
Total Knee Replacement Surgery
Sponsor
Meir Medical Center
Enrollment
60
Primary Endpoint
postoperative pain measured by Visual Analogue Scale
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
June 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David segal

Principle Investigator

Meir Medical Center

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

Arms & Interventions

Spinal block

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)

Intervention: Spinal Block

Spinal block

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)

Intervention: Total knee replacement

General anesthesia

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)

Intervention: General anesthetic

General anesthesia

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)

Intervention: Total knee replacement

Outcomes

Primary Outcomes

postoperative pain measured by Visual Analogue Scale

Time Frame: 48 hours

Visual Analogue Scale scores of pain will be documented at different timed during the first 48 postoperative hours

Secondary Outcomes

  • Achievements in physical therapy measured by walking distance on the first postoperative day(24 hours)

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