Effect of Adding Magnesium Sulphate in Pericapsular Nerve Group Block

NCT06180031 | Unknown Phase 2

• 1 other identifier: 04-2023-200535
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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)

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Postoperative pain management

  total amount of postoperative morphine consumption in the first 24 hours postoperatively.

  24 hours postoperatively

Secondary Outcomes (1)

• Visual analog scale

  24 hours postoperatively

Study Arms (2)

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

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

Group M

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Alaa M Attia, Professor

  Assiut University

  STUDY CHAIR

• Fatma A Abd Diab, Associate Professor

  South Egypt's cancer institute, Assiut University

  STUDY DIRECTOR

• Moaz Tohamy, Lecturer

  South Egypt's cancer institute, Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mustafa M Bekhet, MBBCH

CONTACT

+201060286688; mustafabekhet708@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 22, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 30, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

EG (1)