Pain After Laparoscopy Results From the Incision, Manipulation of the Abdominal Organs, and Retained CO2(Back Pain)

Comparing the Analgesic Effect of Intraperitoneal and Intravenous Magnesium Sulphate in Diagnostic Gynecological Laparoscopy

Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal cavity with its irritation effect on the diaphragm.Patients will be divided into two groups:

Intraperitoneal (IP) group (20 patients):They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.

Intravenous (IV) group (20 patients):They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain, Acute
• Intervention / Treatment: Drug: intraperitoneal Magnesium sulfate; Drug: intravenous magnesium sulfate

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fouad Soliman, lecturer; Phone Number: 01113815186; Email: fouad_soliman@med.sohag.edu.eg
• Study Contact Backup: Name: Soliman; Phone Number: 01113815186; Email: fouad_soliman@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 52514
    • Recruiting
    • Fouad Soliman
    • Contact: Fouad Soliman; Phone Number: 01113815186; Email: fouad_soliman@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

20-44 years old females, (ASA) class I-II

Exclusion Criteria:

• Patient refusal
• Allergy to MgSO4
• Atrio-ventricular conduction abnormalities
• Drug abuse
• Renal or hepatic or cardiovascular dysfunction
• Prior long-term treatment with calcium channel blockers or magnesium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intraperitoneal magnesium sulfate (IP) group; They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then an intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.	Drug: intraperitoneal Magnesium sulfate; Intraperitoneal (IP) group will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.
Active Comparator: Intravenous magnesium sulfate (IV) group; They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy.	Drug: intravenous magnesium sulfate; Intravenous (IV) group will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for first dose of rescue analgesia	1st time to feel pain	8 hours
total analgesic doses	total (ketorolac) analgesic consumption	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain	The visual analog scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)	8 hours
sedation	4 points sedation scale: 0= alert and conscious 1 =quietly awake 2= asleep but easily arousable 3= deep sleep	8 hours
adverse events	side effects	8 hours
serum mgso4 level	serum level of mgso4 at end of operation and after 2 hours	2 hours

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Fouad Soliman, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Anticipated): February 2, 2022
• Study Completion (Anticipated): February 5, 2022

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: mgso4,laparoscopy ,intraperitoneal
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: 2007 (King Faisal University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No