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Not yet recruitingNCT06180031Peng BlockUpdated Dec 22, 2023

Effect of Adding Magnesium Sulphate in Pericapsular Nerve Group Block

A Phase 2/3 interventional study of Pericapsular nerve group block using bupivicaine and magnesium sulphate in Hip Fractures, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-22.

Sponsored by Assiut University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2/3
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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)
02

Conditions studied

  • Hip Fractures

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03

In context

Hip Fractures

822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.

This study's planned enrollment of 62 is below the median of 90 across 529 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • No intervention
    Group C (control)

    will have Peng block using 20mg bupivacaine 0.25%

  • Active comparator
    Group M

    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

  • DrugPericapsular 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

06

What researchers measure

Primary outcomes

  1. Postoperative pain management

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

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Visual analog scale

    It's a scale from 0 to 10 where 0 means no pain and 10 means worst pain imaginable

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Assiut University Hospital
    Assiut, 71515, Egypt
    • Mustafa M Bekhet, MBBCH · Contact · mustafabekhet708@gmail.com · +201060286688
    • Mustafa M Bekhet, MBBCH · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06180031
Lead sponsor
Assiut University
Responsible party
Mustafa Mahmoud Muhammed Bekhet (Doctor, Assiut University) — Principal investigator
First posted
Dec 22, 2023
Start date
Jan 1, 2024 (estimated)
Primary completion
Jan 1, 2025 (estimated)
Completion
Mar 30, 2025 (estimated)
Last update
Dec 22, 2023

Study contacts

Mustafa M Bekhet, MBBCH
Contact
mustafabekhet708@gmail.com
+201060286688
Alaa M Attia, Professor
study chair · Assiut University
Fatma A Abd Diab, Associate Professor
study director · South Egypt's cancer institute, Assiut University
Moaz Tohamy, Lecturer
study director · South Egypt's cancer institute, Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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