NCT04903743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

May 24, 2021

Last Update Submit

May 25, 2021

Conditions

Diabetic Patient

Outcome Measures

Primary Outcomes (1)

  • duration of postoperative analgesia

    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

Study Arms (2)

group B

PLACEBO COMPARATOR

28ml of 0.25% bupivacaine and 2ml normal saline

Drug: bupivacaine

group BM

ACTIVE COMPARATOR

received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.

Drug: bupivacaineDrug: magnesium sulfate

Interventions

bupivacaineDRUG

group B received 28ml of 0.25% bupivacaine and 2ml normal saline

group Bgroup BM
magnesium sulfateDRUG

group BM received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.

group BM

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

rehab Abd Elaziz

Alexandria, 000000, Egypt

Location

MeSH Terms

Interventions

BupivacaineMagnesium Sulfate

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor of Anesthesia

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 26, 2021

Study Start

January 10, 2021

Primary Completion

June 20, 2021

Study Completion

July 10, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations

EG(1)