Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block

Magnesium Sulfate Causing Adverse Effects in Therapeutic Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158647
• Other study ID #: IRB0000871250
• Status: Completed
• Phase: Phase 2
• Start date: August 12, 2018
• Est. completion date: April 21, 2020

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 21, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Magnesium Sulfate Causing Adverse Effects in Therapeutic Use

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Mahmoud S Elmansy	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Abdelrady S Ibrahim, MD

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Carré 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. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative incisional pain	Postoperative incisional pain was evaluated by VRS	2 hours postoperatively
Primary	Postoperative incisional pain	Postoperative incisional pain was evaluated by VRS	4 hours postoperatively
Primary	Postoperative incisional pain	Postoperative incisional pain was evaluated by VRS	6 hours postoperatively
Primary	Postoperative incisional pain	Postoperative incisional pain was evaluated by VRS	12 hours postoperatively
Primary	Postoperative incisional pain	Postoperative incisional pain was evaluated by VRS	18 hours postoperatively
Primary	Postoperative incisional pain	Postoperative incisional pain was evaluated by VRS	24 hours postoperatively