Effect of Adding Magnesium Sulphate in Pericapsular Nerve... | NCT06180031

Studies
Effect of Adding Magnesium Sulphate in Pericapsular Nerve Group Block

NCT06180031

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 22, 2023Actual

Enrollment

62Estimated

Phase

Phase 2Phase 3

Conditions

Hip Fractures

Interventions

Pericapsular nerve group block using bupivicaine and magnesium sulphate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Mar 30, 2025Estimated

First Submitted Date

Dec 2, 2023

First Submission Date that Met QC Criteria

Dec 21, 2023

First Posted Date

Dec 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2023

Last Update Posted Date

Dec 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our aim will be to compare the analgesic efficacy and safety of magnesium sulphate as an adjuvant to bupivacaine in pericapsular nerve group block in Hip joint surgeries.

Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative.
Our secondary outcome of the study: mean arterial blood pressure, heart rate, respiratory rate, adverse effects, block related complication, sedation score (by Ramsay sedation scale) and pain score (by Visual Analog Scale)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group C (control)	No Intervention	will have Peng block using 20mg bupivacaine 0.25%
Group M	Active Comparator	will have PENG block with 2mg magnesium sulphate 10% as an adjuvant to 20mg of bupivacaine 0.25%	Drug: Pericapsular nerve group block using bupivicaine and magnesium sulphate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pericapsular nerve group block using bupivicaine and magnesium sulphate	Drug	This technique involves the deposition of the local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain management	total amount of postoperative morphine consumption in the first 24 hours postoperatively.	24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Visual analog scale	It's a scale from 0 to 10 where 0 means no pain and 10 means worst pain imaginable	24 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients aged 18 years or more.
- Patients with American society of anesthesiologists (ASA) classification class I or II
- Patients weight range from 50 to 90 Kgs

Exclusion Criteria:

• Patient refusal of peripheral nerve block
- Patient with infection at the site of injection
- Patient with coagulopathy
- Patients with known allergy to used medications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mustafa M Bekhet, MBBCH	Contact	+201060286688		mustafabekhet708@gmail.com

Overall Officials

Name	Affiliation	Role
Alaa M Attia, Professor	Assiut University	Study Chair
Fatma A Abd Diab, Associate Professor	South Egypt's cancer institute, Assiut University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospital		Asyut		71515	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008278	Magnesium Sulfate

Ancestor Terms

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids

Browse Leaves

Not provided

Browse Branches

Not provided