Sleeve GastrectomyNCT07451327
Effect of Adding Magnesium Sulphate to Bupivacaine in Laparoscopic Periportal Preperitoneal Local Infiltration in Laparoscopic Sleeve Gastrectomy
A study testing ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY in people with Sleeve Gastrectomy and Magnesium Sulfate, run by Alexandria University at 1 site in Egypt.
Trial summary
EFFECT OF ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY Our study shows that adding magnesium to the block will prolong duration of analgesia and decrease total amount of analgesia needed will decrease time of stay at PACU and… Read more about this study
- Who is it for?
- Ages 18 to 50 hours
- Conditions the study is for
- Sleeve Gastrectomy, Magnesium Sulfate, Bupivacaine
- What is being tested?
- ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Feb 2026
- Phase
- Interventional
- 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 18 to 50 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Age: 18-50 years of age.
- American Society of Anesthesiologists (ASA) physical status class I-III
- Body mass index 30-50 kg/m².
Who cannot join
- Severe cardiac disorder
- Chronic renal failure
- Liver cirrhosis
- Allergy to bupivacaine
- Patients with history of chronic opioid consumption
Trial locations and contacts
1 site in 1 country.
About this study
EFFECT OF ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY Our study shows that adding magnesium to the block will prolong duration of analgesia and decrease total amount of analgesia needed will decrease time of stay at PACU and stay at hospital
Read the detailed description
Obesity isn't just a cosmetic issue, it is a medical condition, sometimes considered a disease in which excess body fat has accumulated to an extent that can potentially have negative effects on health, The increasing prevalence of obesity has become a significant concern worldwide. It increases the risk of many other diseases and health problems that include heart diseases, diabetes, high blood pressure, fatty liver, apnea, even certain cancers.
Bariatric surgery has become the most effective way to lose weight. Health care providers recommend bariatric surgery if other conservative weight loss methods have failed. Surgical weight loss operations have been performed over the last 20 years. Bariatric surgery procedures include gastric bypass, gastric band, duodenal switch and sleeve gastrectomy, Laparoscopic sleeve gastrectomy (LSG) is an effective procedure for weight loss. It has become the most commonly performed bariatric surgery with low morbidity without long term malabsorptive risks.
In patients undergoing LSG, postoperative pain management is essential for reducing complications due to excessive opioid use, early mobilization and shortening hospital stays, Multimodal analgesia seems to be the gold standard in the treatment of acute pain, particularly for bariatric surgery patients who frequently have numerous coexisting conditions, one of these conditions is obstructive sleep apnea (OSA) which is common among obese individuals, making safe analgesic treatment a bit challenging.
Perioperative multimodal analgesia uses a combination of analgesic medications that act on various sites and pathways in an additive or synergistic manner to achieve pain relief with minimal or no opioid consumption, The clinical practice trends are now shifting towards opioid sparing anaesthesia.
Local infiltration analgesia is widely used as a component of multimodal analgesia. It involves the injection of a local anaesthetic near the surgical incision site to provide analgesia. Periportal preperitoneal local anaesthetic infiltration is a technique that was first described by Dean et al, for pain relief in laparoscopic hernia repair and is now gaining popularity.
The pre-incisional periportal laparoscopic preperitoneal local anaesthetic technique (PLPLAT) is an effective technique to reduce postoperative pain and can decrease the postoperative opioid consumption after surgery, promoting early mobilization and patient satisfaction due to fewer side effects.
Intra-peritoneal instillation of bupivacaine with or without adjuvants is one of popular modalities used to prevent post-operative pain. The local anaesthetic agents provide antinociception by affecting nerve membrane-associated proteins and by inhibiting the release and action of prostaglandins, which stimulate the nociceptors and cause inflammation, blocking of visceral pain conduction. Absorption from a large peritoneal surface may be the mechanism of analgesia.
One of these adjuvants is magnesium sulfate which is used in combination with local anaesthetics to help reduce onset of effect, prolong the duration of action and to increase the chance of successful blockade.
Administration of magnesium sulfate (MgSO4) through different routes has been used in anaesthetic practice for decreasing perioperative pain. Although magnesium has mild sedative effects, it lowers intraoperative anaesthetics requirements, this is advantageous in reducing the residual anaesthetic effects in obese patients.
Magnesium sulfate also has been used to attenuate the adverse haemodynamic changes associated with pneumoperitoneum which is created during laparoscopy. These changes include abrupt elevation of mean blood pressure, heart rate and systemic vascular resistance, this is because MgSO4 prevents the adrenal medullary release of catecholamines as well as their secretion from adrenergic nerve endings, in addition, it has a direct effect on blood vessels producing vasodilatation with a subsequent reduction in blood pressure. Apart from that, it also has the ability to attenuate vasopressin-mediated vasoconstriction. In addition, carbon dioxide reacts with the tissue and activates the emergence of sour products which put local pressure on the nerve endings of the peritoneum, noxious stimulation leads to the release of glutamate and aspartate which bind to various subclasses of excitatory amino acids receptors including (NMDA) receptors. Magnesium inhibits calcium entry into the cell through a noncompetitive blockade of the N-methyl-d aspartate (NMDA) receptor, this may explain how magnesium works when it is given intraperitoneally.
The present work will study the effect of adding magnesium sulphate to bupivacaine in periportal preperitoneal local anaesthetic infiltration in laparoscopic sleeve gastrectomy. magnesium will prolong duration of analgesia and decrease total amount of analgesia needed will decrease time of stay at PACU and stay at hospital
- Conditions
- Sleeve Gastrectomy, Magnesium Sulfate, Bupivacaine
- Being tested
- ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY
- Keywords
- sleeve gasterectomy, magnesuim sulphate, bupvacaine, periportal preperitoneal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMYDrug
Also called MAGNESIUM, BUPIVACAINE, PERIPORTAL, PREPERITONEAL
ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY
| Study group | Role | What they receive |
|---|---|---|
| group c who received bupivacaine in periportal preperitoneal local infiltration | Experimental | who received bupivacaine in periportal preperitoneal local infiltration Receives: Drug: ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY |
| group m who received bupivacaine and magnesium in periportal preperitoneal local infiltration | Experimental | who received bupivacaine and magnesium in periportal preperitoneal local infiltration Receives: Drug: ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of pain control using vas score
postoperative pain will be assessed using visual analog scale (VAS) where 0 indicates no pain and 10 indicates worst pain
Measured: 24 hours postoperatively
Secondary outcomes (3)
patient satisfaction
satisfaction will be assessed 24 hours postoperatively using 4 point scale (poor ,fair ,good, excellent )
Measured: 24 hours postoperatively
time to first postoperative analgesic requirement
time from the end of surgery to the first request of analgesia ,measured in hours
Measured: 24hours postoperatively
total amount of morphine consumption
total cumulative dose of intravenous morphine as a rescue analgesia within the first 24 hours postoperatively ,measured in milligrams (mg)
Measured: 24hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 May 2024
- Primary completion1 Jan 2025
- Study completion1 Feb 2026
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 Sleeve GastrectomyStudies of the same condition, open and under way.
- More trials run by Alexandria 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsayed, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451327
- Sponsor's protocol ID
- 0108928
- Status last verified
- May 2025
- First submitted
- 20 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: through clinical trials
Publications
Randa AS, Zakaria AM, Mahmoud AA, Yasir AA. Intraperitoneal local instillation of levobupivacine versus magnesium sulphate versus levobupivacine plus magnesium sulphate for post operative pain relief after laparoscopic sleeve gastrectomy: Prospective Randomized clinical trial. Med J Cairo Univ 2021; 603-10
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Magnesium Sulphate to Bupivacaine in Laparoscopic Periportal Preperitoneal Local Infiltration in Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07451327
- Acronym / sponsor ID
- 0108928
- Conditions
- Sleeve Gastrectomy, Magnesium Sulfate, Bupivacaine
- Keywords
- sleeve gasterectomy, magnesuim sulphate, bupvacaine, periportal preperitoneal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 5 Mar 2026 (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.
EFFECT OF ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY Our study shows that adding magnesium to the block will prolong duration of analgesia and decrease total amount of analgesia needed will decrease time of stay at PACU and stay at hospital
Detailed description
Obesity isn't just a cosmetic issue, it is a medical condition, sometimes considered a disease in which excess body fat has accumulated to an extent that can potentially have negative effects on health, The increasing prevalence of obesity has become a significant concern worldwide. It increases the risk of many other diseases and health problems that include heart diseases, diabetes, high blood pressure, fatty liver, apnea, even certain cancers.
Bariatric surgery has become the most effective way to lose weight. Health care providers recommend bariatric surgery if other conservative weight loss methods have failed. Surgical weight loss operations have been performed over the last 20 years. Bariatric surgery procedures include gastric bypass, gastric band, duodenal switch and sleeve gastrectomy, Laparoscopic sleeve gastrectomy (LSG) is an effective procedure for weight loss. It has become the most commonly performed bariatric surgery with low morbidity without long term malabsorptive risks.
In patients undergoing LSG, postoperative pain management is essential for reducing complications due to excessive opioid use, early mobilization and shortening hospital stays, Multimodal analgesia seems to be the gold standard in the treatment of acute pain, particularly for bariatric surgery patients who frequently have numerous coexisting conditions, one of these conditions is obstructive sleep apnea (OSA) which is common among obese individuals, making safe analgesic treatment a bit challenging.
Perioperative multimodal analgesia uses a combination of analgesic medications that act on various sites and pathways in an additive or synergistic manner to achieve pain relief with minimal or no opioid consumption, The clinical practice trends are now shifting towards opioid sparing anaesthesia.
Local infiltration analgesia is widely used as a component of multimodal analgesia. It involves the injection of a local anaesthetic near the surgical incision site to provide analgesia. Periportal preperitoneal local anaesthetic infiltration is a technique that was first described by Dean et al, for pain relief in laparoscopic hernia repair and is now gaining popularity.
The pre-incisional periportal laparoscopic preperitoneal local anaesthetic technique (PLPLAT) is an effective technique to reduce postoperative pain and can decrease the postoperative opioid consumption after surgery, promoting early mobilization and patient satisfaction due to fewer side effects.
Intra-peritoneal instillation of bupivacaine with or without adjuvants is one of popular modalities used to prevent post-operative pain. The local anaesthetic agents provide antinociception by affecting nerve membrane-associated proteins and by inhibiting the release and action of prostaglandins, which stimulate the nociceptors and cause inflammation, blocking of visceral pain conduction. Absorption from a large peritoneal surface may be the mechanism of analgesia.
One of these adjuvants is magnesium sulfate which is used in combination with local anaesthetics to help reduce onset of effect, prolong the duration of action and to increase the chance of successful blockade.
Administration of magnesium sulfate (MgSO4) through different routes has been used in anaesthetic practice for decreasing perioperative pain. Although magnesium has mild sedative effects, it lowers intraoperative anaesthetics requirements, this is advantageous in reducing the residual anaesthetic effects in obese patients.
Magnesium sulfate also has been used to attenuate the adverse haemodynamic changes associated with pneumoperitoneum which is created during laparoscopy. These changes include abrupt elevation of mean blood pressure, heart rate and systemic vascular resistance, this is because MgSO4 prevents the adrenal medullary release of catecholamines as well as their secretion from adrenergic nerve endings, in addition, it has a direct effect on blood vessels producing vasodilatation with a subsequent reduction in blood pressure. Apart from that, it also has the ability to attenuate vasopressin-mediated vasoconstriction. In addition, carbon dioxide reacts with the tissue and activates the emergence of sour products which put local pressure on the nerve endings of the peritoneum, noxious stimulation leads to the release of glutamate and aspartate which bind to various subclasses of excitatory amino acids receptors including (NMDA) receptors. Magnesium inhibits calcium entry into the cell through a noncompetitive blockade of the N-methyl-d aspartate (NMDA) receptor, this may explain how magnesium works when it is given intraperitoneally.
The present work will study the effect of adding magnesium sulphate to bupivacaine in periportal preperitoneal local anaesthetic infiltration in laparoscopic sleeve gastrectomy. magnesium will prolong duration of analgesia and decrease total amount of analgesia needed will decrease time of stay at PACU and stay at hospital
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group c who received bupivacaine in periportal preperitoneal local infiltration | Experimental | Drug: ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMYwho received bupivacaine in periportal preperitoneal local infiltration |
| group m who received bupivacaine and magnesium in periportal preperitoneal local infiltration | Experimental | Drug: ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMYwho received bupivacaine and magnesium in periportal preperitoneal local infiltration |
Who may qualify
- Ages
- 18 to 50 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Age: 18-50 years of age.
Key exclusion criteria (5 listed)
- Severe cardiac disorder
- Chronic renal failure
- Liver cirrhosis
- Allergy to bupivacaine
- Patients with history of chronic opioid consumption
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 |
|---|---|---|
| ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMYAlso: MAGNESIUM, BUPIVACAINE, PERIPORTAL, PREPERITONEALADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY | Drug | group c who received bupivacaine in periportal preperitoneal local infiltration, group m who received bupivacaine and magnesium in periportal preperitoneal local infiltration |
Primary outcome
quality of pain control using vas score
Time frame: 24 hours postoperatively
postoperative pain will be assessed using visual analog scale (VAS) where 0 indicates no pain and 10 indicates worst pain
3 secondary outcomes
patient satisfaction
Time frame: 24 hours postoperatively
time to first postoperative analgesic requirement
Time frame: 24hours postoperatively
total amount of morphine consumption
Time frame: 24hours postoperatively
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 5 Mar 2026.
- BackgroundRanda AS, Zakaria AM, Mahmoud AA, Yasir AA. Intraperitoneal local instillation of levobupivacine versus magnesium sulphate versus levobupivacine plus magnesium sulphate for post operative pain relief after laparoscopic sleeve gastrectomy: Prospective Randomized clinical trial. Med J Cairo Univ 2021; 603-10
- Individual participant dataSharing planned: Yes. through clinical trials
Related trials for Sleeve Gastrectomy
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Recruiting
HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
Obesity (BMI > 35), Obesity (BMI > 35) and Diabetes Mellitus
RecruitingObservational study
15-years Outcomes of Sleeve Gastrectomy on Weight Loss
Bariatric Surgery, Sleeve Gastrectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY in people with Sleeve Gastrectomy and Magnesium Sulfate, run by Alexandria University 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 3 inclusion and 5 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 5 Mar 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
quality of pain control using vas score (time frame: 24 hours postoperatively). 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 NCT07451327, 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 5 Mar 2026.