Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT07248332
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efface of Lidocaine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy
Sponsor:
Liaquat National Hospital & Medical College
Organization:
Study Overview
Official Title:
The Efface of Lidocaine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective interventional study was carried out at Liaquat National Hospital and Medical College to evaluate and compare the postoperative analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. A total of 168 ASA I-II patients were enrolled and randomly allocated into two groups of 84 participants each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope randomization technique in a double-blind, placebo-controlled design. All patients received standardized general anesthesia with propofol, isoflurane, and atracurium, and routine postoperative care included intravenous diclofenac sodium and ondansetron. Postoperative pain was measured at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS) to assess and compare the efficacy and duration of analgesia between the two groups. The study aimed to provide insight into the relative analgesic performance of lidocaine and magnesium sulphate, supporting improved pain management strategies following laparoscopic cholecystectomy.
Detailed Description:
Optimal management of postoperative pain is crucial for enhancing recovery, minimizing stress responses, and promoting better outcomes after laparoscopic cholecystectomy. This prospective interventional study was carried out in the Department of Anesthesiology at Liaquat National Hospital and Medical College to compare the analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing elective laparoscopic cholecystectomy.
A total of 168 patients classified as ASA I-II with uncomplicated symptomatic gallstones were enrolled after obtaining ethical approval and written informed consent. Participants were randomly assigned into two equal groups of 84 patients each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope technique. The study employed a double-blind, placebo-controlled design to ensure unbiased evaluation. Patients with ASA III-V, chronic pain disorders, psychiatric conditions, pregnancy or breastfeeding, major hepatic, renal, or cardiovascular disease, or recent use of opioids or NSAIDs were excluded from the study.
All patients underwent standard preoperative assessment, including overnight fasting and anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Intraoperative monitoring included heart rate, blood pressure, ECG, oxygen saturation, and end-tidal CO₂. Residual neuromuscular blockade was reversed with neostigmine at the end of surgery. Postoperative care included intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron for prevention of nausea and vomiting.
Postoperative pain intensity was recorded at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients experiencing significant pain were administered intravenous Kinz 5 mg as rescue analgesia, and the timing was documented by nursing staff.
This study provided important information on the comparative efficacy of lidocaine and magnesium sulphate for postoperative pain management, highlighting their potential role in multimodal analgesic strategies to improve patient comfort and recovery following laparoscopic cholecystectomy.
A total of 168 patients classified as ASA I-II with uncomplicated symptomatic gallstones were enrolled after obtaining ethical approval and written informed consent. Participants were randomly assigned into two equal groups of 84 patients each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope technique. The study employed a double-blind, placebo-controlled design to ensure unbiased evaluation. Patients with ASA III-V, chronic pain disorders, psychiatric conditions, pregnancy or breastfeeding, major hepatic, renal, or cardiovascular disease, or recent use of opioids or NSAIDs were excluded from the study.
All patients underwent standard preoperative assessment, including overnight fasting and anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Intraoperative monitoring included heart rate, blood pressure, ECG, oxygen saturation, and end-tidal CO₂. Residual neuromuscular blockade was reversed with neostigmine at the end of surgery. Postoperative care included intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron for prevention of nausea and vomiting.
Postoperative pain intensity was recorded at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients experiencing significant pain were administered intravenous Kinz 5 mg as rescue analgesia, and the timing was documented by nursing staff.
This study provided important information on the comparative efficacy of lidocaine and magnesium sulphate for postoperative pain management, highlighting their potential role in multimodal analgesic strategies to improve patient comfort and recovery following laparoscopic cholecystectomy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: