A Phase 2/3 interventional study of Saline Solution and Magnesium Sulfate in Pain, Postoperative, sponsored by Centre de Maternité de Monastir. Completed at 2 sites in Tunisia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-08.
Sponsored by Centre de Maternité de Monastir · Phase 2/3, Interventional, and Treatment
Among 43 studies testing Magnesium Sulfate in Pain, Postoperative — 7 open to participants now, 7 under way, none of them phase 3. Magnesium Sulfate · Pain, Postoperative.
Among the 43 studies testing Magnesium Sulfate in Pain, Postoperative, this one is the 2nd largest by enrollment, is one of 3 that started in 2017, is one of 4 in phase 2/3, and was the 13th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 150 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →7 of the 43 studies testing Magnesium Sulfate in Pain, Postoperative are open now, in 2 countries. Each count lists the studies.
Magnesium Sulfate: first FDA approval 1981 (TIS-U-SOL IN PLASTIC CONTAINER). What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →43 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 3 started in 2017.
Median enrollment 70 across the 43 interventional studies. Of the 25 that completed or were terminated, 4 (16%) have results posted.
None of the 43 has an industry lead sponsor. The 10 most frequent:
Centre de Maternité de Monastir is the lead sponsor of 2 studies on the registry; none are open to participants now.
Centre de Maternité de Monastir has 2 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
4 of the studies testing Magnesium Sulfate in Pain, Postoperative that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07773220Khyber Teaching HospitalMagnesium Sulphate Versus Dexamethasone With TAP Block for Post-Cesarean Analgesia | 2027-02-28 |
| NCT07803601Ain Shams UniversityEffect of Intravenous Magnesium on Postoperative Systemic Inflammatory Response in Patients Undergoing Colorectal Cancer Surgery | 2027-03-01 |
| NCT07840183Northwestern UniversityEpidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release | 2027-09 |
| NCT07760207Assiut UniversityTopical Magnesium Sulfate Versus Peritonsillar Bupivacaine for Post-Tonsillectomy Pain Relief in Children | 2027-09 |
Among the 43 studies testing Magnesium Sulfate in Pain, Postoperative, from their registry updates:
: Pain modulation is very important after operation, particularly for women who undergo caesarean section. A pain-free postoperative period is essential following a caesarean section so new mothers may care for and bond with their neonates. The consequences of the improper pain management which raise the healthcare costs and prolong the recovery process. Intrathecal adjuvants are often administered during this procedure to provide significant analgesia, but they may also have bothersome side effects. Intrathecal midazolam and magnesium sulfate produces effective postoperative analgesia with no significant side effects.
Objectives: This prospective, randomized, double-blind study was designed to compare the analgesic efficacy and safety of intrathecal midazolam vs. Magnesium sulfate vs plain bupivacaine as an adjunct to bupivacaine in pregnancy patients scheduled for elective caesarean section.
The patients were randomly allocated using a computer-generated randomization list to one of three groups that contained 50 parturients each via www.randomization.com.
Group C (control group): 10 mg hyperbaric bupivacaine 0.5% (2 ml) + 100γ morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 1 ml physiological saline.
Group Mg (magnesium sulfate group): 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 100 mg MgSO4 (1 ml).
Group MDZ (midazolam group): 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ Sufentanil (0.5ml) + 2mg Midazolam (0.4 + 0.6cc physiological saline (1 ml)).
The parturients as well as the anesthetist who evaluated the protocol did not know the nature of the adjuvant injected in spinal anesthesia. The presented syringe contained one of the two adjuvants or the physiological serum in the same volume and of the same appearance. It was prepared by an anesthesist who was not included in the analysis of the study and was presented anonymously to the anesthetist in charge of the patient. A postoperative monitoring (PO) was performed during the first 24 hours in the intensive care unit by the anesthesist who did not know the nature of the injected adjuvant. All patients were kept nil per os for six hours prior to surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group
Drug: Saline Solution
Magnesium sulfate group
Drug: Magnesium Sulfate
Midazolam group
Drug: Midazolam 5 MG/ML Injection
Spinal injection of 10 mg hyperbaric bupivacaine 0.5% (2 ml) + 100γ morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 1 ml physiological saline.
Also known as: Saline
Spinal injection of 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 100 mg MgSO4 (1 ml).
Also known as: Magnesium
Drug page: Midazolam
Spinal injection of 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ Sufentanil (0.5ml) + 2mg Midazolam (0.4 + 0.6cc physiological saline (1 ml)).
Also known as: Midazolam
The first requirement for analgesic
Postoperatively, the patients were observed for the duration of analgesia using the Visual Analog Scale for Pain (VAS Pain), from 0 - 10 (with 0 being no pain and 10 being the most severe pain imaginable) at H2, H4, H6, H10, H12, H24 at rest and coughing or mobilization until supplementary analgesia was required. The duration of effective analgesia was defined as the time interval between administration of the IT drug to the time of first analgesic request or a VAS ≥ 4. Rescue analgesics were given in the form of a paracetamol injection (1g IV) as well as nefopam (20 mg IV) injection once the VAS was recorded as 4 or more.
Time frame: 24 hours postoperative
The sensory blocks
. The assessments of the sensory and motor blocks were taken at the end of each minute until the maximum level of block (T4) was achieved and were assessed using a short, beveled 22-gauge needle and tested at the mid_clavicular line on the chest, trunk, and legs on either side. The duration of the sensory block was defined as the time for regression of the sensory block from the maximum block height to the L-1 dermatome as evaluated by a pinprick.
Time frame: 24 hours postoperative
The motor block
The motor block was assessed using the Modified Bromage score (1:Complete block (unable to move feet or knees); 2: Almost complete block (able to move feet only); 3: Partial block (just able to move knees); 4: Detectable weakness of hip flexion while supine (full flexion of knees); 5: No detectable weakness of hip flexion while supine; 6: Able to perform partial knee bend).
Time frame: 24 hours postoperative
Hypotension
Hypotension was defined as a more than 20% decrease in the systolic blood pressure from the baseline. It was treated with IV fluids and an additional bolus of intravenous (IV) ephedrine (0.1 mg/kg) was repeated at the discretion of the attending anesthesiologist at incremental doses
Time frame: 24 hours post operative
Bradycardia
Bradycardia was defined as a decrease in the pulse rate to less than 45 beats per minutes and was treated with an IV injection of 0.5mg atropine sulfate.
Time frame: 24 hours post operative
Sedation Score
The sedation scores were recorded using the observer's assessment of the Ramsay scale (Ramsay 1: Anxious, agitated, restless; Ramsay 2: Cooperative, oriented, tranquil; Ramsay 3: Responsive to commands only; Ramsay 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsay 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsay 6: No response to light glabellar tap or loud auditory stimulus).
Time frame: 24 hours post operative
Maternal satisfaction
Maternal satisfaction concerning the anesthetic technique was evaluated by the following score:• Excellent = comfort and satisfactory analgesia• Good = average comfort and acceptable analgesia • Poor = significant and lasting discomfort.
Time frame: 24 hours post operative
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Magnesium Sulfate · Midazolam
Centre de Maternité de Monastir