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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Faculity of Medicine Alexanduria University

    Alexandria, Sydy Bashr

Other trials in Egypt

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

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 groups in NCT07451327
Study groupRoleWhat they receive
group c who received bupivacaine in periportal preperitoneal local infiltrationExperimentalwho 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 infiltrationExperimentalwho 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.

  1. 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)
  1. patient satisfaction

    satisfaction will be assessed 24 hours postoperatively using 4 point scale (poor ,fair ,good, excellent )

    Measured: 24 hours postoperatively

  2. time to first postoperative analgesic requirement

    time from the end of surgery to the first request of analgesia ,measured in hours

    Measured: 24hours postoperatively

  3. 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.

  1. First posted5 Mar 2026
  2. Study start1 May 2024
  3. Primary completion1 Jan 2025
  4. Study completion1 Feb 2026

Resources

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)
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

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.

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