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Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block

NCT ID: NCT05158647

Last Updated: 2021-12-15

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-12

Study Completion Date

2020-04-21

Brief Summary

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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.

Detailed Description

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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. Patients were divided into two groups of 45 patients each by means of coded envelopes according to the LA used for IIIH blockade. In the first group (control group), patients received 10 ml 0.5% isobaric bupivacaine plus 1 ml normal saline for IIIH blockade, whereas in the second group (MgSo4 group), 10 ml 0.5% isobaric bupivacaine and 1 ml of MgSo4 10% were prepared. All the patients received intrathecal 3 ml 0.5% hyperbaric bupivacaine, and then, IIIH blockade was performed under ultrasound guidance according to the group. Postoperatively, VRS scores,analgesic duration, and any complication were recorded.

Conditions

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Magnesium Sulfate Causing Adverse Effects in Therapeutic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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control group

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

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

MgSo4 group

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

Group Type ACTIVE_COMPARATOR

MgSo4

Intervention Type DRUG

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

Interventions

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normal saline

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

Intervention Type OTHER

MgSo4

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

Intervention Type DRUG

Other Intervention Names

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Control group Magnesium Sulphate

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Abdelrady S Ibrahim, MD

OTHER

Sponsor Role lead

Responsible Party

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Abdelrady S Ibrahim, MD

Professor Of Anesthesia and ICU

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mahmoud S Elmansy

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Mansoura University

Locations

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Mahmoud S Elmansy

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 11530753 (View on PubMed)

Other Identifiers

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IRB0000871250

Identifier Type: -

Identifier Source: org_study_id