Femoral/Sciatic Block for Knee Surgery

NCT02882152 | Completed Results

• 1 other identifier: 0257/09
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Knee arthroplasty has a high potential for postoperative pain. This study compares analgesia and postoperative bleeding from intrathecal morphine with the continuous femoral and a single-shot sciatic nerve blockades.

Conditions

Knee Injuries

Keywords

Analgesia; Nerve Block; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Analgesic Efficacy

  Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).

  baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

Secondary Outcomes (1)

• Postoperative Bleeding

  baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours

Study Arms (2)

femoral blockade

EXPERIMENTAL

femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve

Procedure: femoral nerve blockade

Morphine

ACTIVE COMPARATOR

intrathecal morphine

Procedure: morphine

Interventions

femoral nerve blockade PROCEDURE

femoral nerve blockade followed by a catheter placement for continuous infusion and a "single shot" block of the sciatic nerve at the end of the surgery

femoral blockade

morphine PROCEDURE

Intrathecal morphine injection

Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18 years old, American Society of Anesthesiologists (ASA) physical status from I to III who underwent total knee arthroplasty

You may not qualify if:

• Patients aged below 18 years old, ASA IV or V physical status, infection near the puncture site, coagulation disorders, preexisting neurological disorders, allergy report to local anesthetics, pregnancy and lactation, contraindications to spinal block and refusal to sign an informed consent form

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (9)

• Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115.

  PMID: 25111605 BACKGROUND

• Guay J, Kopp S. Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD005059. doi: 10.1002/14651858.CD005059.pub4.

  PMID: 26731032 BACKGROUND

• Bujedo BM, Santos SG, Azpiazu AU. A review of epidural and intrathecal opioids used in the management of postoperative pain. J Opioid Manag. 2012 May-Jun;8(3):177-92. doi: 10.5055/jom.2012.0114.

  PMID: 22798178 BACKGROUND

• Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x.

  PMID: 19462494 BACKGROUND

• Li XM, Huang CM, Zhong CF. Intrathecal morphine verse femoral nerve block for pain control in total knee arthroplasty: A meta-analysis from randomized control trials. Int J Surg. 2016 Aug;32:89-98. doi: 10.1016/j.ijsu.2016.06.043. Epub 2016 Jul 6.

  PMID: 27370542 BACKGROUND

• Kadic L, Boonstra MC, DE Waal Malefijt MC, Lako SJ, VAN Egmond J, Driessen JJ. Continuous femoral nerve block after total knee arthroplasty? Acta Anaesthesiol Scand. 2009 Aug;53(7):914-20. doi: 10.1111/j.1399-6576.2009.01965.x. Epub 2009 Apr 15.

  PMID: 19388886 BACKGROUND

• Grape S, Kirkham KR, Baeriswyl M, Albrecht E. The analgesic efficacy of sciatic nerve block in addition to femoral nerve block in patients undergoing total knee arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2016 Oct;71(10):1198-209. doi: 10.1111/anae.13568. Epub 2016 Jul 29.

  PMID: 27469381 BACKGROUND

• Raj PP, Parks RI, Watson TD, Jenkins MT. A new single-position supine approach to sciatic-femoral nerve block. Anesth Analg. 1975 Jul-Aug;54(4):489-93. doi: 10.1213/00000539-197507000-00020.

  PMID: 1170786 BACKGROUND

• Alvarez NER, Ledesma RJG, Hamaji A, Hamaji MWM, Vieira JE. Continuous femoral nerve blockade and single-shot sciatic nerve block promotes better analgesia and lower bleeding for total knee arthroplasty compared to intrathecal morphine: a randomized trial. BMC Anesthesiol. 2017 May 12;17(1):64. doi: 10.1186/s12871-017-0355-x.

  PMID: 28499420 DERIVED

MeSH Terms

Conditions

Knee Injuries; Agnosia; Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Joaquim Edson Vieira
• Organization: University of São Paulo

joaquimev@usp.br

+55 11 3061 8716

Study Officials

• Alfredo J Mansur, MD. PhD

  Comissão de Ética para Análise de Projetos de Pesquisa-CAPPesq - HCFMUSP

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 26, 2016
• Results First Posted: December 26, 2016

Record last verified: 2014-09

Data Sharing

• IPD Sharing: Will not share