POPLITEAL SCIATIC NERVE BLOCK FOR DIABETIC FOOT SURGERIES

Sponsor

Alexandria University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04903743

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Patient	Drug: bupivacaine Drug: magnesium sulfate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2021

Anticipated Primary Completion Date :

Jun 20, 2021

Anticipated Study Completion Date :

Jul 10, 2021

Arms and Interventions

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%.

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%.

Outcome Measures

Primary Outcome Measures

duration of postoperative analgesia [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	rehab Abd Elaziz	Alexandria		Egypt	000000

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

rehab zayed, Assisstant Professor of Anesthesia, Alexandria University

ClinicalTrials.gov Identifier:

NCT04903743

Other Study ID Numbers:

0106292

First Posted:

May 26, 2021

Last Update Posted:

May 27, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetic Foot

Magnesium Sulfate

Bupivacaine

Study Results

No Results Posted as of May 27, 2021