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Completed

NCT Number: NCT05158647

Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block

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.

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Key information

Conditions

Magnesium Sulfate Causing Adverse Effects in Therapeutic Use

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Mahmoud S Elmansy

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Saline

Other

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

Other names: Control group

MgSO4

Drug

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

Other names: Magnesium Sulphate

Primary outcomes

  1. Postoperative incisional pain

    Time frame: 2 hours postoperatively

    Postoperative incisional pain was evaluated by VRS

  2. Postoperative incisional pain

    Time frame: 4 hours postoperatively

    Postoperative incisional pain was evaluated by VRS

  3. Postoperative incisional pain

    Time frame: 6 hours postoperatively

    Postoperative incisional pain was evaluated by VRS

  4. Postoperative incisional pain

    Time frame: 12 hours postoperatively

    Postoperative incisional pain was evaluated by VRS

  5. Postoperative incisional pain

    Time frame: 18 hours postoperatively

    Postoperative incisional pain was evaluated by VRS

  6. Postoperative incisional pain

    Time frame: 24 hours postoperatively

    Postoperative incisional pain was evaluated by VRS

Sponsors and collaborators

Lead sponsor

Abdelrady S Ibrahim, MD

Other

Registry information

Official study title

Efficacy of Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block in Acute Postherniorrhaphy Pain

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 15, 2021
Registry last updated
Dec 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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