Preoperative Continuous Sciatic Perineural Analgesia in Patients Undergoing Lower Limb Revascularization

Peripheral Vascular Disease Clinical Trial

Official title:

Preoperative Continuous Sciatic Perineural Analgesia, as a Bridge Therapy for Ischemic Pain, in Patients Undergoing Lower Limb Revascularization: a Retrospective Descriptive Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286971
• Other study ID #: 25206319.3.0000.5279
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Hospital Municipal Miguel Couto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the pain score numerical rating, after sciatic analgesic continuous block, in patients with ischemic pain before surgery of limb revascularization. All patients received those blocks to control ischemic severe pain.

Description:

Peripheral Obstructive Arterial Disease (PAD) is a disease with a prevalence of 10 to 25% in the population over 55 years, increasing with age, and may have disabling pain as a symptom, and sometimes the surgical approach is required. In the context of public hospital in Rio de Janeiro, where patients need to wait for surgery, the Anesthesiology and Acute Pain service routinely has sciatic nerve analgesic block in the popliteal region as a preoperative procedure.

The primary objective of the present study is to describe a series of cases where the technique was applied in order to relieve the pain of these patients, following the Pain Score Numerical rating as a reference. Secondary objectives will be to describe difficulties associated with the technique and possible associated adverse factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• preoperative continuous sciatic-popliteal nerve block

• lower limb angioplasty

• peripheral arterial disease;

• between 2017 and 2018 years;

• correct filling of numerical rating pain evaluation in the medical record

Exclusion Criteria:

• peripheral block to treat another pathology or condition in te same patient;

• peripheral block at another concomitant site (other than the popliteal);

• No adequate record of the care received in the medical record

• if medical record is not available during the data collection period

Related Conditions & MeSH terms

• Ischemia
• Ischemic Leg
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Locations

Country	Name	City	State
Brazil	Rafael M Linhares	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Municipal Miguel Couto

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

Aubuchon A, Arnold WD, Bracewell A, Hoyle JC. Sciatic neuropathy due to popliteal fossa nerve block. Muscle Nerve. 2017 Oct;56(4):822-824. doi: 10.1002/mus.25622. Epub 2017 Jun 6. — View Citation

Compère V, Cornet C, Fourdrinier V, Maitre AM, Duparc F, Biga N, Dureuil B. [Evaluation of continuous nerve block for postoperative pain management in orthopaedic surgery]. Ann Fr Anesth Reanim. 2005 Jul;24(7):795-801. French. — View Citation

Dao T, Amaro-Driedger D, Mehta J. Successful treatment of Raynaud's syndrome in a lupus patient with continuous bilateral popliteal sciatic nerve blocks: a case report. Local Reg Anesth. 2016 Jun 15;9:35-7. doi: 10.2147/LRA.S97111. eCollection 2016. — View Citation

Dingemans SA, de Ruiter KJ, Birnie MFN, Goslings JC, van Samkar G, Schepers T. Comparable Postoperative Pain Levels Using 2 Different Nerve Blocks in the Operative Treatment of Displaced Intra-articular Calcaneal Fractures. Foot Ankle Int. 2017 Dec;38(12):1352-1356. doi: 10.1177/1071100717730337. Epub 2017 Sep 16. — View Citation

Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005. — View Citation

Joshi G, Gandhi K, Shah N, Gadsden J, Corman SL. Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities. J Clin Anesth. 2016 Dec;35:524-529. doi: 10.1016/j.jclinane.2016.08.041. Epub 2016 Oct 20. Review. — View Citation

Kim NY, Lee KY, Bai SJ, Hong JH, Lee J, Park JM, Kim SH. Comparison of the effects of remifentanil-based general anesthesia and popliteal nerve block on postoperative pain and hemodynamic stability in diabetic patients undergoing distal foot amputation: A retrospective observational study. Medicine (Baltimore). 2016 Jul;95(29):e4302. doi: 10.1097/MD.0000000000004302. — View Citation

Luiten WE, Schepers T, Luitse JS, Goslings JC, Hermanides J, Stevens MF, Hollmann MW, van Samkar G. Comparison of continuous nerve block versus patient-controlled analgesia for postoperative pain and outcome after talar and calcaneal fractures. Foot Ankle Int. 2014 Nov;35(11):1116-21. doi: 10.1177/1071100714546640. Epub 2014 Aug 12. — View Citation

Thomas K, Barrett B, Tupper R, Dacenko-Grawe L, Holm K. Pain management after total knee arthroplasty: a case–control study of continuous nerve block therapy. Orthop Nurs. 2014 Sep-Oct;33(5):268-76. doi: 10.1097/NOR.0b013e3182879bd9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in numerical pain scale	Numerical Pain Scale (END) self-assessed by the patient before and after 24 hours of continuous analgesic block of the sciatic nerve, with infusion of levobupivacaine 0,125% or ropivacaine 0,2%. The scale score is 0-10 (0= no pain; 10 = pain as bad as can be)	24 hours after placement of sciatic catheter
Secondary	change in numerical pain scale	Numerical Pain Scale (END) self-assessed by the patient before and after 72 hours of continuous analgesic block of the sciatic nerve, with infusion of levobupivacaine 0,125% or ropivacaine 0,2%. The scale score is 0-10 (0= no pain; 10 = pain as bad as can be)	72 hours after placement of sciatic catheter
Secondary	classification of technique difficulties	To report, qualitatively, the presence of variations or difficulties in the use of the technique, such as: failure of the technique (FT); existence of concomitant venous analgesia (VA); inadequate registration of the technique (IR)	72 hours after placement of sciatic catheter
Secondary	classifications of possible complications	Report, qualitatively, the presence of possible complications, such as: hyperemia of the catheter insertion site (HC); the presence of pus (PUS); catheter displacement (CD)	72 hours after placement of sciatic catheter