Magnesium Sulfate Causing Adverse Effects in Therapeutic UsePhase 2NCT05158647
Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block
A Phase 2 study testing normal saline and MgSo4 in people with Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, run by Abdelrady S Ibrahim, MD at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Magnesium Sulfate Causing Adverse Effects in Therapeutic Use
- What is being tested?
- normal saline and MgSo4
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2018to 21 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult male
- American Society of Anesthesiologists physical status I or II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block in Acute Postherniorrhaphy Pain
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.
Read the 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.
- Being tested
- normal saline, MgSo4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineOther
Also called Control group
10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade
MgSo4Drug
Also called Magnesium Sulphate
10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | 10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade Receives: Other: normal saline |
| MgSo4 group | Active comparator | 10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used. Receives: Drug: MgSo4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative incisional pain
Postoperative incisional pain was evaluated by VRS
Measured: 2 hours postoperatively
Postoperative incisional pain
Postoperative incisional pain was evaluated by VRS
Measured: 4 hours postoperatively
Postoperative incisional pain
Postoperative incisional pain was evaluated by VRS
Measured: 6 hours postoperatively
Postoperative incisional pain
Postoperative incisional pain was evaluated by VRS
Measured: 12 hours postoperatively
Postoperative incisional pain
Postoperative incisional pain was evaluated by VRS
Measured: 18 hours postoperatively
Postoperative incisional pain
Postoperative incisional pain was evaluated by VRS
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start12 Aug 2018
- Primary completion7 Feb 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnesium Sulfate Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdelrady S Ibrahim, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Mahmoud S Elmansy, Principal investigator, Faculty of Medicine Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158647
- Sponsor's protocol ID
- IRB0000871250
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11530753
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Magnesium Sulfate to Bupivacaine for Ilioinguinal and Iliohypogastric Nerve Block in Acute Postherniorrhaphy Pain
- ClinicalTrials.gov ID
- NCT05158647
- Acronym / sponsor ID
- IRB0000871250
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Abdelrady S Ibrahim, MDUniversity, hospital or other
- Study start
- 12 Aug 2018 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: normal saline10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade |
| MgSo4 group | Active comparator | Drug: MgSo410 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male
- American Society of Anesthesiologists physical status I or II
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal salineAlso: Control group10-ml 0.5% isobaric bupivacaine and 1ml normal saline were prepared for IIIH blockade | Other | control group |
| MgSo4Also: Magnesium Sulphate10 ml 0.5% isobaric bupivacaine and 1ml of MgSo4 10% (100 mg) were used | Drug | MgSo4 group |
Primary outcome
Postoperative incisional pain
Time frame: 2 hours postoperatively
Postoperative incisional pain was evaluated by VRS
Postoperative incisional pain
Time frame: 4 hours postoperatively
Postoperative incisional pain was evaluated by VRS
Postoperative incisional pain
Time frame: 6 hours postoperatively
Postoperative incisional pain was evaluated by VRS
Postoperative incisional pain
Time frame: 12 hours postoperatively
Postoperative incisional pain was evaluated by VRS
Postoperative incisional pain
Time frame: 18 hours postoperatively
Postoperative incisional pain was evaluated by VRS
Postoperative incisional pain
Time frame: 24 hours postoperatively
Postoperative incisional pain was evaluated by VRS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Results publication: PubMed 11530753Carre 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud S Elmansy principal investigator
Faculty of Medicine Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing normal saline and MgSo4 in people with Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, run by Abdelrady S Ibrahim, MD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative incisional pain (time frame: 2 hours postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05158647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.