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Clinical Trials/NCT07451327
NCT07451327CompletedNot Applicable

Effect of Adding Magnesium Sulphate to Bupivacaine in Laparoscopic Periportal Preperitoneal Local Infiltration in Laparoscopic Sleeve Gastrectomy

Alexandria University1 site in 1 country68 target enrollmentStarted: May 1, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
68
Locations
1
Primary Endpoint
quality of pain control using vas score

Study Overview

Brief 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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Hours to 50 Hours (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

group c who received bupivacaine in periportal preperitoneal local infiltration

Experimental

who received bupivacaine in periportal preperitoneal local infiltration

Intervention: ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY (Drug)

group m who received bupivacaine and magnesium in periportal preperitoneal local infiltration

Experimental

who received bupivacaine and magnesium in periportal preperitoneal local infiltration

Intervention: ADDING MAGNESIUM SULPHATE TO BUPIVACAINE IN LAPAROSCOPIC PERIPORTAL PREPERITONEAL LOCAL INFILTRATION IN LAPAROSCOPIC SLEEVE GASTRECTOMY (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • patient satisfaction(24 hours postoperatively)
  • time to first postoperative analgesic requirement(24hours postoperatively)
  • total amount of morphine consumption(24hours postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Elsayed

assistant lecturer ,alexandria university

Alexandria University

Study Sites (1)

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