Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block

• Sponsor: Abdelrady S Ibrahim, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT05158647
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.3
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Magnesium Sulfate Causing Adverse Effects in Therapeutic Use	Other: normal saline; Drug: MgSo4	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block in Acute Postherniorrhaphy Pain
• Actual Study Start Date: Aug 12, 2018
• Actual Primary Completion Date: Feb 7, 2020
• Actual Study Completion Date: Apr 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control group 10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade	Other: normal saline; 10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade; Other Names: Control group
Active Comparator: MgSo4 group 10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used.	Drug: MgSo4; 10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used; Other Names: Magnesium Sulphate

Outcome Measures

Primary Outcome Measures

1. Postoperative incisional pain [2 hours postoperatively]

   Postoperative incisional pain was evaluated by VRS

2. Postoperative incisional pain [4 hours postoperatively]

   Postoperative incisional pain was evaluated by VRS

3. Postoperative incisional pain [6 hours postoperatively]

   Postoperative incisional pain was evaluated by VRS

4. Postoperative incisional pain [12 hours postoperatively]

   Postoperative incisional pain was evaluated by VRS

5. Postoperative incisional pain [18 hours postoperatively]

   Postoperative incisional pain was evaluated by VRS

6. Postoperative incisional pain [24 hours postoperatively]

   Postoperative incisional pain was evaluated by VRS

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mahmoud S Elmansy	Mansoura		Egypt

Sponsors and Collaborators

• Abdelrady S Ibrahim, MD

Investigators

• Principal Investigator: Mahmoud S Elmansy, Faculty of Medicine Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abdelrady S Ibrahim, MD, Professor Of Anesthesia and ICU, Assiut University
• ClinicalTrials.gov Identifier: NCT05158647
• Other Study ID Numbers: IRB0000871250
• First Posted: Dec 15, 2021
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Magnesium Sulfate

Study Results

No Results Posted as of Dec 15, 2021