Abdominal HysterectomyPhase 2NCT06367595
Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy
A Phase 2 study testing Magnesium sulfate in people with Abdominal Hysterectomy, run by Assiut University.
Trial summary
The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Abdominal Hysterectomy
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 40-65 years old
- Patients with ASA clinical status I/II
- Patients eligible for abdominal hysterectomy
- Oncological surgery
Who cannot join
- Body mass index (BMI) ≥ 40/kg / m2
- Previous abdominal surgery (except cesarean section)
- Severe cardiovascular, renal, and hepatic dysfunction
- Contraindications to spinal anesthesia
- Neuromuscular diseases
- Inappropriate for spinal anesthesia
- Patient refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications.
Read the detailed description
Abdominal Hysterectomy (AH) is associated with an intense inflammatory response that can result in moderate to severe postoperative pain, sometimes difficult to control.
Postoperative pain can cause many complications such as restlessness, increased sympathetic activity, high blood pressure, and tachycardia. Opioids are effective analgesics; however, they produce unwanted side effects, such as respiratory depression, nausea, and vomiting. Nonopioid drugs can decrease opioid usage and dependency.
Different adjuvants have been added to local anesthetics to increase the duration of the regional anesthesia, decrease pain-relieving drugs, and delay the onset of postoperative pain.
According to numerous reports, Magnesium sulfate has analgesic effects and lowers opioid consumption in many surgeries especially abdominal surgeries.
The analgesic properties of magnesium are based on acting as a non-competitive antagonist of N-Methyl-D-Aspartate (NMDA) receptors in central nervous system and regulating the calcium influx into the cell. These properties avoid the central sensitization mechanisms due to the stimulation of peripheral nociceptive nerves In the spinal cord, magnesium sulfate decreases pain transmission by hyperpolarizing spinal interneurons via G-protein-mediated activation of potassium channels and by decreasing the release of the neurotransmitters (substance P and glutamate) from primary afferent terminals.
Adequate postoperative pain relief can enhance recovery and increase patient satisfaction.
- Conditions
- Abdominal Hysterectomy
- Being tested
- Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| intrathecal | Active comparator | will include 30 patients who will receive
* Intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus magnesium sulfate 30 mg of 0.5 ml volume.
* 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia, then 250 ml of isotonic saline infusion over 2 hours. Receives: Drug: Magnesium sulfate |
| intravenous | Active comparator | will include 30 patients who will receive
- 30 mg/kg magnesium sulfate at a concentration of 100 mg/ml (regarding the ideal body weight) in 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia (intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus 0.5 ml of isotonic saline), and then 10 mg/kg/h magnesium sulfate in 250 ml isotonic saline infusion over 2 hours. Receives: Drug: Magnesium sulfate |
| placebo | Placebo comparator | will include 30 patients who will receive
* intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus 0.5 ml of isotonic saline.
* 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia then 250 ml of isotonic saline infusion over 2 hours. Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on postoperative pain after abdominal hysterectomy using visual analog score
the pain intensity assessment at rest and on movement (from lying to sitting on the bed) using Visual analog score (VAS) This will measure pain intensity from 0 to 10 (goal is to be < 4) 0: no pain 3: mild pain 7: moderate pain 10: severe pain
Measured: Baseline
Secondary outcomes (4)
sedation by Ramsay sedation scale
From 1 to 6
- Patient is anxious and agitated or restless, or both.
- Patient is cooperative, oriented, and tranquil.
- Patient responds to commands only.
- Patient exhibits brisk response to light glabellar tab or loud auditory stimulus.
- Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
- Patient exhibits no response.
Measured: Baseline
time of the first opioid request
time of the first opioid request, concentration and the occurrence of complications (hypotension, bradycardia, itching, urinary retention.) all over 24 hours postoperatively.
Measured: Baseline
Mean arterial blood pressures (MAP)
mean arterial blood pressures (MAP) will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.
Measured: Baseline
Heart rate (HR)
Heart rate (HR) will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Abdominal HysterectomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Salah Hassanein, Assiut University
- Investigators
- Hamdy A Youssef, Professor, Study chair, Assuit University HospitalMohamed F Mostafa, Ass professor, Study chair, Assuit University HospitalAhmed M Elsonbaty, Lecturer, Study director, Assuit University HospitalMarwa S Hassanein, Resident, Principal investigator, Assuit University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367595
- Sponsor's protocol ID
- Intrathecal MgSO4
- Status last verified
- May 2024
- First submitted
- 20 Feb 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandsborg B. Pain following hysterectomy: epidemiological and clinical aspects. Dan Med J. 2012 Jan;59(1):B4374.
PubMed 22239844Kim TK, Yoon JR. Comparison of the neuroendocrine and inflammatory responses after laparoscopic and abdominal hysterectomy. Korean J Anesthesiol. 2010 Oct;59(4):265-9. doi: 10.4097/kjae.2010.59.4.265. Epub 2010 Oct 21.
PubMed 21057617Wu CL, Fleisher LA. Outcomes research in regional anesthesia and analgesia. Anesth Analg. 2000 Nov;91(5):1232-42. doi: 10.1097/00000539-200011000-00035. No abstract available.
PubMed 11049915Camu F, Van Aken H, Bovill JG. Postoperative analgesic effects of three demand-dose sizes of fentanyl administered by patient-controlled analgesia. Anesth Analg. 1998 Oct;87(4):890-5. doi: 10.1097/00000539-199810000-00027.
PubMed 9768789Koltka K, Uludag E, Senturk M, Yavru A, Karadeniz M, Sengul T, Ozyalcin S. Comparison of equipotent doses of ropivacaine-fentanyl and bupivacaine-fentanyl in spinal anaesthesia for lower abdominal surgery. Anaesth Intensive Care. 2009 Nov;37(6):923-8. doi: 10.1177/0310057X0903700606.
PubMed 20014598Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents. doi: 10.1097/00000539-200209000-00031.
PubMed 12198056De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
PubMed 23669270Do SH. Magnesium: a versatile drug for anesthesiologists. Korean J Anesthesiol. 2013 Jul;65(1):4-8. doi: 10.4097/kjae.2013.65.1.4. Epub 2013 Jul 19.
PubMed 23904932Ishii H, Kohno T, Yamakura T, Ikoma M, Baba H. Action of dexmedetomidine on the substantia gelatinosa neurons of the rat spinal cord. Eur J Neurosci. 2008 Jun;27(12):3182-90. doi: 10.1111/j.1460-9568.2008.06260.x. Epub 2008 Jun 1.
PubMed 18554299Shang AB, Gan TJ. Optimising postoperative pain management in the ambulatory patient. Drugs. 2003;63(9):855-67. doi: 10.2165/00003495-200363090-00002.
PubMed 12678572Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
PubMed 30211382Khan BA, Guzman O, Campbell NL, Walroth T, Tricker JL, Hui SL, Perkins A, Zawahiri M, Buckley JD, Farber MO, Ely EW, Boustani MA. Comparison and agreement between the Richmond Agitation-Sedation Scale and the Riker Sedation-Agitation Scale in evaluating patients' eligibility for delirium assessment in the ICU. Chest. 2012 Jul;142(1):48-54. doi: 10.1378/chest.11-2100.
PubMed 22539644Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Yazdi AP, Esmaeeli M, Gilani MT. Effect of intravenous magnesium on postoperative pain control for major abdominal surgery: a randomized double-blinded study. Anesth Pain Med (Seoul). 2022 Jul;17(3):280-285. doi: 10.17085/apm.22156. Epub 2022 Jul 28.
PubMed 35918860Benevides ML, Fialho DC, Linck D, Oliveira AL, Ramalho DHV, Benevides MM. Intravenous magnesium sulfate for postoperative analgesia after abdominal hysterectomy under spinal anesthesia: a randomized, double-blind trial. Braz J Anesthesiol. 2021 Sep-Oct;71(5):498-504. doi: 10.1016/j.bjane.2021.01.008. Epub 2021 Mar 21.
PubMed 33762190
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT06367595
- Acronym / sponsor ID
- Intrathecal MgSO4
- Conditions
- Abdominal Hysterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Apr 2024 (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.
The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications.
Detailed description
Abdominal Hysterectomy (AH) is associated with an intense inflammatory response that can result in moderate to severe postoperative pain, sometimes difficult to control.
Postoperative pain can cause many complications such as restlessness, increased sympathetic activity, high blood pressure, and tachycardia. Opioids are effective analgesics; however, they produce unwanted side effects, such as respiratory depression, nausea, and vomiting. Nonopioid drugs can decrease opioid usage and dependency.
Different adjuvants have been added to local anesthetics to increase the duration of the regional anesthesia, decrease pain-relieving drugs, and delay the onset of postoperative pain.
According to numerous reports, Magnesium sulfate has analgesic effects and lowers opioid consumption in many surgeries especially abdominal surgeries.
The analgesic properties of magnesium are based on acting as a non-competitive antagonist of N-Methyl-D-Aspartate (NMDA) receptors in central nervous system and regulating the calcium influx into the cell. These properties avoid the central sensitization mechanisms due to the stimulation of peripheral nociceptive nerves In the spinal cord, magnesium sulfate decreases pain transmission by hyperpolarizing spinal interneurons via G-protein-mediated activation of potassium channels and by decreasing the release of the neurotransmitters (substance P and glutamate) from primary afferent terminals.
Adequate postoperative pain relief can enhance recovery and increase patient satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intrathecal | Active comparator | Drug: Magnesium sulfatewill include 30 patients who will receive * Intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus magnesium sulfate 30 mg of 0.5 ml volume. * 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia, then 250 ml of isotonic saline infusion over 2 hours. |
| intravenous | Active comparator | Drug: Magnesium sulfatewill include 30 patients who will receive - 30 mg/kg magnesium sulfate at a concentration of 100 mg/ml (regarding the ideal body weight) in 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia (intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus 0.5 ml of isotonic saline), and then 10 mg/kg/h magnesium sulfate in 250 ml isotonic saline infusion over 2 hours. |
| placebo | Placebo comparator | Drug: Magnesium sulfatewill include 30 patients who will receive * intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus 0.5 ml of isotonic saline. * 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia then 250 ml of isotonic saline infusion over 2 hours. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 40-65 years old
- Patients with ASA clinical status I/II
- Patients eligible for abdominal hysterectomy
- Oncological surgery
Key exclusion criteria (7 listed)
- Body mass index (BMI) ≥ 40/kg / m2
- Previous abdominal surgery (except cesarean section)
- Severe cardiovascular, renal, and hepatic dysfunction
- Contraindications to spinal anesthesia
- Neuromuscular diseases
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 |
|---|---|---|
| Magnesium sulfateIV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine | Drug | intrathecal, intravenous, placebo |
Primary outcome
effect on postoperative pain after abdominal hysterectomy using visual analog score
Time frame: Baseline
the pain intensity assessment at rest and on movement (from lying to sitting on the bed) using Visual analog score (VAS) This will measure pain intensity from 0 to 10 (goal is to be < 4) 0: no pain 3: mild pain 7: moderate pain 10: severe pain
4 secondary outcomes
sedation by Ramsay sedation scale
Time frame: Baseline
time of the first opioid request
Time frame: Baseline
Mean arterial blood pressures (MAP)
Time frame: Baseline
Heart rate (HR)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 22239844Brandsborg B. Pain following hysterectomy: epidemiological and clinical aspects. Dan Med J. 2012 Jan;59(1):B4374.
- Background: PubMed 21057617Kim TK, Yoon JR. Comparison of the neuroendocrine and inflammatory responses after laparoscopic and abdominal hysterectomy. Korean J Anesthesiol. 2010 Oct;59(4):265-9. doi: 10.4097/kjae.2010.59.4.265. Epub 2010 Oct 21.
- Background: PubMed 11049915Wu CL, Fleisher LA. Outcomes research in regional anesthesia and analgesia. Anesth Analg. 2000 Nov;91(5):1232-42. doi: 10.1097/00000539-200011000-00035. No abstract available.
- Background: PubMed 9768789Camu F, Van Aken H, Bovill JG. Postoperative analgesic effects of three demand-dose sizes of fentanyl administered by patient-controlled analgesia. Anesth Analg. 1998 Oct;87(4):890-5. doi: 10.1097/00000539-199810000-00027.
- Background: PubMed 20014598Koltka K, Uludag E, Senturk M, Yavru A, Karadeniz M, Sengul T, Ozyalcin S. Comparison of equipotent doses of ropivacaine-fentanyl and bupivacaine-fentanyl in spinal anaesthesia for lower abdominal surgery. Anaesth Intensive Care. 2009 Nov;37(6):923-8. doi: 10.1177/0310057X0903700606.
- Background: PubMed 12198056Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents. doi: 10.1097/00000539-200209000-00031.
- Background: PubMed 23669270De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
- Background: PubMed 23904932Do SH. Magnesium: a versatile drug for anesthesiologists. Korean J Anesthesiol. 2013 Jul;65(1):4-8. doi: 10.4097/kjae.2013.65.1.4. Epub 2013 Jul 19.
- Background: PubMed 18554299Ishii H, Kohno T, Yamakura T, Ikoma M, Baba H. Action of dexmedetomidine on the substantia gelatinosa neurons of the rat spinal cord. Eur J Neurosci. 2008 Jun;27(12):3182-90. doi: 10.1111/j.1460-9568.2008.06260.x. Epub 2008 Jun 1.
- Background: PubMed 12678572Shang AB, Gan TJ. Optimising postoperative pain management in the ambulatory patient. Drugs. 2003;63(9):855-67. doi: 10.2165/00003495-200363090-00002.
- Background: PubMed 30211382Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
- Background: PubMed 22539644Khan BA, Guzman O, Campbell NL, Walroth T, Tricker JL, Hui SL, Perkins A, Zawahiri M, Buckley JD, Farber MO, Ely EW, Boustani MA. Comparison and agreement between the Richmond Agitation-Sedation Scale and the Riker Sedation-Agitation Scale in evaluating patients' eligibility for delirium assessment in the ICU. Chest. 2012 Jul;142(1):48-54. doi: 10.1378/chest.11-2100.
- Individual participant dataSharing planned: No
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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.
Hamdy A Youssef, Professor study chair
Assuit University Hospital
Mohamed F Mostafa, Ass professor study chair
Assuit University Hospital
Ahmed M Elsonbaty, Lecturer study director
Assuit University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium sulfate in people with Abdominal Hysterectomy, run by Assiut University.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa S Hassanein, Res (00201159511004, marwasalah2525@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect on postoperative pain after abdominal hysterectomy using visual analog score (time frame: Baseline). 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 NCT06367595, which also lists 15 linked publications.
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 29 May 2024.