POPLITEAL SCIATIC NERVE BLOCK FOR DIABETIC FOOT SURGERIES

May 25, 2021 updated by: rehab zayed, Alexandria University

ULTRASOUND GUIDED POPLITEAL SCIATIC NERVE BLOCK USING BUPIVACAINE ALONE OR COMBINED WITH MAGNESIUM SULFATE FOR DIABETIC FOOT SURGERIES

Popliteal Sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. Different additives have been used with local anaesthetics to achieve dense and prolonged block. Magnesium sulfate possesses analgesic properties owing to its effect on NMDA receptors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 000000
        • rehab Abd Elaziz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (ASA) II or III
  • scheduled for diabetic foot surgeries.

Exclusion Criteria:

  • Patients who refused the anaesthetic technique,
  • whose BMI ≥ 35 kg/ m2,
  • unable to properly describe postoperative pain to investigator (dementia, delirium, psychiatric and neurological disorders),
  • patients with coagulopathy, skin infection at the site of injection,
  • preoperative use of opioid or non-steroidal anti-inflammatory drugs,
  • allergy or contraindication to studied medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: group B
28ml of 0.25% bupivacaine and 2ml normal saline
Drug: bupivacaine
group B received 28ml of 0.25% bupivacaine and 2ml normal saline
Active Comparator: group BM
received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.
Drug: bupivacaine
group B received 28ml of 0.25% bupivacaine and 2ml normal saline
Drug: magnesium sulfate
group BM received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of postoperative analgesia
Time Frame: 24 hours
evaluate the effects of adding magnesium sulfate to bupivacaine versus bupivacaine alone in popliteal sciatic nerve block with ultrasound guidance for diabetic foot surgeries as regards the duration of postoperative analgesia
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Anticipated)

June 20, 2021

Study Completion (Anticipated)

July 10, 2021

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0106292

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Patient

Clinical Trials on bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe