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Effect of Adding Magnesium Sulphate in Pericapsular Nerve Group Block

NCT ID: NCT06180031

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-03-30

Brief Summary

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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

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group C (control)

will have Peng block using 20mg bupivacaine 0.25%

Group Type NO_INTERVENTION

No interventions assigned to this group

Group M

will have PENG block with 2mg magnesium sulphate 10% as an adjuvant to 20mg of bupivacaine 0.25%

Group Type ACTIVE_COMPARATOR

Pericapsular nerve group block using bupivicaine and magnesium sulphate

Intervention Type DRUG

This technique involves the deposition of the local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus

Interventions

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Pericapsular nerve group block using bupivicaine and magnesium sulphate

This technique involves the deposition of the local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Mahmoud Muhammed Bekhet

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa M Attia, Professor

Role: STUDY_CHAIR

Assiut University

Fatma A Abd Diab, Associate Professor

Role: STUDY_DIRECTOR

South Egypt's cancer institute, Assiut University

Moaz Tohamy, Lecturer

Role: STUDY_DIRECTOR

South Egypt's cancer institute, Assiut University

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mustafa M Bekhet, MBBCH

Role: CONTACT

Phone: +201060286688

Email: [email protected]

Facility Contacts

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Mustafa M Bekhet, MBBCH

Role: primary

Other Identifiers

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04-2023-200535

Identifier Type: -

Identifier Source: org_study_id