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

NCT ID: NCT03176758

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-06-01

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.

Conditions

Total Knee Replacement Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Spinal Block

Intervention Type: DRUG

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

Total knee replacement

Intervention Type: DEVICE

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

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)

Group Type: ACTIVE_COMPARATOR

General anesthetic

Intervention Type: DRUG

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

Total knee replacement

Intervention Type: DEVICE

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

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 IBW diluted with 100cc Normal Saline

Intervention Type: DRUG

General 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

Intervention Type: DRUG

Total knee replacement

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

Intervention Type: DEVICE

Other Intervention Names

Neurological block

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David segal

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

david segal, MD

Role: CONTACT

dudisegal@gmail.com

529423951

References

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.

Reference Type: BACKGROUND

PMID: 28331362 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23788068 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19916251 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19130163 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16651569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23612126 (View on PubMed)

Other Identifiers

0094-17-MMC

Identifier Type: -

Identifier Source: org_study_id