Femoral/Sciatic Block for Knee Surgery

Knee Injuries Clinical Trial

Official title:

Continuous Femoral Nerve Blockade and Single Shot Sciatic Nerve Block Compared to Intrathecal Morphine for Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882152
• Other study ID #: 0257/09
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: December 23, 2016
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Procedure:
• 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
• morphine
Intrathecal morphine injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

References & Publications (8)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Postoperative Bleeding	Postoperative bleeding volume (ml)	baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours	No