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

Total Knee Replacement Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03176758
• Other study ID #: 0094-17-MMC
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 21, 2017
• Last updated: June 2, 2017
• Start date: June 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2017
• Source: Meir Medical Center
• Contact: david segal, MD
• Phone: 529423951
• Email: dudisegal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Total Knee Replacement Surgery

Intervention

Drug:
• 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
• 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

Device:
• Total knee replacement
A total knee arthroplasty surgery, which is not the intervention of interest

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

References & Publications (6)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Achievements in physical therapy measured by walking distance on the first postoperative day	The patient will walk with a walker under the surgeon's supervision, and the surgeon will measure with the distance the succeeded walking	24 hours