MedDataX Logo

Femoral/Sciatic Block for Knee Surgery

NCT ID: NCT02882152

Last Updated: 2016-12-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study aims to compare intrathecal morphine as a technique for analgesia with the femoral nerve blockade associated with a single-shot sciatic nerve blockade. Analgesic efficacy, the incidence of adverse effects, and postoperative bleeding were evaluated

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Injuries

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Analgesia Nerve Block Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

femoral blockade

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

Group Type EXPERIMENTAL

femoral nerve blockade

Intervention Type 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

Morphine

intrathecal morphine

Group Type ACTIVE_COMPARATOR

morphine

Intervention Type PROCEDURE

Intrathecal morphine injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

femoral nerve blockade

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

Intervention Type PROCEDURE

morphine

Intrathecal morphine injection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alfredo J Mansur, MD. PhD

Role: STUDY_DIRECTOR

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

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25111605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26731032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22798178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19462494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27370542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19388886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27469381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1170786 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28499420 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0257/09

Identifier Type: -

Identifier Source: org_study_id