Effect of Adding Magnesium Sulphate to Bupivacaine in Laparoscopic Periportal Preperitoneal Local Infiltration in Laparoscopic Sleeve Gastrectomy
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sydy Bashr
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Alexandria, Sydy Bashr, Egypt
- Faculity of Medicine Alexanduria University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Age: 18-50 years of age.
- American Society of Anesthesiologists (ASA) physical status class I-III
- Body mass index 30-50 kg/m².
Exclusion Criteria:
- Severe cardiac disorder
- Chronic renal failure
- Liver cirrhosis
- Allergy to bupivacaine
- Patients with history of chronic opioid consumption
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: group c who received bupivacaine in periportal preperitoneal local infiltration
who received bupivacaine in periportal preperitoneal local infiltration
|
ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY
Other Names:
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Experimental: group m who received bupivacaine and magnesium in periportal preperitoneal local infiltration
who received bupivacaine and magnesium in periportal preperitoneal local infiltration
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ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of pain control using vas score
Time Frame: 24 hours postoperatively
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postoperative pain will be assessed using visual analog scale (VAS) where 0 indicates no pain and 10 indicates worst pain
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24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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patient satisfaction
Time Frame: 24 hours postoperatively
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satisfaction will be assessed 24 hours postoperatively using 4 point scale (poor ,fair ,good, excellent )
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24 hours postoperatively
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time to first postoperative analgesic requirement
Time Frame: 24hours postoperatively
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time from the end of surgery to the first request of analgesia ,measured in hours
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24hours postoperatively
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total amount of morphine consumption
Time Frame: 24hours postoperatively
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total cumulative dose of intravenous morphine as a rescue analgesia within the first 24 hours postoperatively ,measured in milligrams (mg)
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24hours postoperatively
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0108928
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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