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

NCT03176758 | Unknown Phase 4 FDA Drug

• 1 other identifier: 0094-17-MMC
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Total Knee Replacement Surgery

Outcome Measures

Primary Outcomes (1)

• postoperative pain measured by Visual Analogue Scale

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

  48 hours

Secondary Outcomes (1)

• Achievements in physical therapy measured by walking distance on the first postoperative day

  24 hours

Study Arms (2)

Spinal block

ACTIVE COMPARATOR

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)

Drug: Spinal Block; Device: Total knee replacement

General anesthesia

ACTIVE COMPARATOR

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)

Drug: General anesthetic; Device: Total knee replacement

Interventions

Spinal Block 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

Also known as: Neurological block

Spinal block

General anesthetic 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

General anesthesia

Total knee replacement DEVICE

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

General anesthesia; Spinal block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patient who will undergo total knee arthroplasty

You may not qualify if:

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

Sponsors & Collaborators

• Meir Medical Center: lead

Related Publications (6)

• 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.

  PMID: 28331362 BACKGROUND

• 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.

  PMID: 23788068 BACKGROUND

• 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.

  PMID: 19916251 BACKGROUND

• 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.

  PMID: 19130163 BACKGROUND

• 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.

  PMID: 16651569 BACKGROUND

• 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.

  PMID: 23612126 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Spinal; Anesthetics, General; Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

david segal, MD

CONTACT

529423951; dudisegal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: June 5, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 5, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share