NCT05158647

Brief Summary

Regional block of ilioinguinal and iliohypogastric (IIIH) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. Magnesium sulfate (MgSo4) blocks N-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (LA) in different anesthetic approaches. Although the prolongation in postoperative duration resulting from the addition of MgSO4 to LA was significant in some literature studies, it was insignificant in others. This study was designed to investigate the adjunctive effect of MgSo4 when added to bupivacaine for IIIH blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (VRS) scores, analgesic consumption, and hemodynamics as secondary outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

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

August 12, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

December 3, 2021

Last Update Submit

December 14, 2021

Conditions

Magnesium Sulfate Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (6)

  • Postoperative incisional pain

    Postoperative incisional pain was evaluated by VRS

    2 hours postoperatively

  • Postoperative incisional pain

    Postoperative incisional pain was evaluated by VRS

    4 hours postoperatively

  • Postoperative incisional pain

    Postoperative incisional pain was evaluated by VRS

    6 hours postoperatively

  • Postoperative incisional pain

    Postoperative incisional pain was evaluated by VRS

    12 hours postoperatively

  • Postoperative incisional pain

    Postoperative incisional pain was evaluated by VRS

    18 hours postoperatively

  • Postoperative incisional pain

    Postoperative incisional pain was evaluated by VRS

    24 hours postoperatively

Study Arms (2)

control group

PLACEBO COMPARATOR

10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade

Other: normal saline

MgSo4 group

ACTIVE COMPARATOR

10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used.

Drug: MgSo4

Interventions

normal salineOTHER

10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade

Also known as: Control group
control group
MgSo4DRUG

10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used

Also known as: Magnesium Sulphate
MgSo4 group

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility Detailsadult male patients with American Society of Anesthesiologists physical status I or II, admitted to the surgical department scheduled for elective nonrelapsing unilateral inguinal herniorrhaphy under spinal anesthesia
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male
  • American Society of Anesthesiologists physical status I or II

You may not qualify if:

  • Patients with body mass index greater than or equal to 35 kg/m2
  • allergy to the study drugs
  • on chronic analgesics or drug containing magnesium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud S Elmansy

Al Mansurah, Egypt

Location

Related Publications (1)

  • Carre P, Mollet J, Le Poultel S, Costey G, Ecoffey C. [Ilio-inguinal Ilio-hypogastic nerve block with a single puncture: an alterantive for anesthesia in emergency inguinal surgery]. Ann Fr Anesth Reanim. 2001 Aug;20(7):643-6. doi: 10.1016/s0750-7658(01)00425-7. French.

    PMID: 11530753RESULT

MeSH Terms

Interventions

Saline SolutionControl GroupsMagnesium Sulfate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Mahmoud S Elmansy

    Faculty of Medicine Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Of Anesthesia and ICU

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 15, 2021

Study Start

August 12, 2018

Primary Completion

February 7, 2020

Study Completion

April 21, 2020

Last Updated

December 15, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)