Clinical trial NCT05158647: Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block
Official title: Efficacy of Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block in Acute Postherniorrhaphy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Magnesium Sulfate Causing Adverse Effects in Therapeutic Use
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 90
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative incisional pain
timeFrame: 2 hours postoperatively
measure: Postoperative incisional pain
timeFrame: 4 hours postoperatively
measure: Postoperative incisional pain
timeFrame: 6 hours postoperatively
measure: Postoperative incisional pain
timeFrame: 12 hours postoperatively
measure: Postoperative incisional pain
timeFrame: 18 hours postoperatively
measure: Postoperative incisional pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mahmoud S Elmansy
Study officials:
affiliation: Faculty of Medicine Mansoura University
name: Mahmoud S Elmansy
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.