Intraperitoneal Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia in Laparoscopic Surgeries in Pediatrics

• ClinicalTrials.gov Identifier: NCT04651556
• Recruitment Status: Completed
• First Posted: December 3, 2020
• Last Update Posted: December 8, 2020
• Sponsor: Menoufia University
• Information provided by (Responsible Party): Ibrahim Walash, Menoufia University

Study Description

Brief Summary:

The investigators are going to study the analgesic efficacy of intraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine versus ordinary used parenteral analgesics for pain relief after laparoscopic surgeries in pediatrics.

Condition or disease	Intervention/treatment	Phase
Intraperitoneal Magnesium Sulphate in Laparoscope in Pediatrics	Drug: Magnesium Sulfate & bupivacaine; Drug: paracetamol & ketorolac	Phase 4

Detailed Description:

Laparoscopic surgery is a modern surgical technique used for various surgeries such as cholecystectomy, appendectomy and hernia repair. There are a number of advantages of this technique including reduced pain and bleeding, shorter recovery time and hospital stay, and over all reduced healthcare costs. The type of pain after laparoscopic surgery differs considerably from that occurs after laparotomy. Usually patients experience diffuse pain in abdomen, back and shoulder. Acute pain after laparoscopic cholecystectomy has three different components: incisional pain (somatic pain), visceral pain (deep intra-abdominal pain), and shoulder pain (presumably referred visceral pain) . Postoperative nausea and vomiting is a commonly observed phenomenon after laparoscopic procedures. Its incidence increases depending on the anesthetic techniques used. Pain intensity usually peaks during the first postoperative period and usually declines over the following 2-3 days. Pain can prolong hospital stay and lead to increased morbidity.

Inadequately treated pain may lead to splinting, loss of sighing and decrease in vital capacity, and these may contribute to postoperative pulmonary morbidity. Various multimodal approaches have, therefore, been tried to ameliorate postoperative pain. These include parenteral analgesics, local infiltration with local anesthetics, epidural and intrathecal opioids and local anesthetics, interpleural and intercostals nerve blocks as well as intraperitoneal routes that in turn has been explored with local anesthetics and opioids . In order to get an instant relief, polypharmacy is commonly practiced which can be potentially harmful to the patient and can lead to re-admission. It has been appreciated that multiple glutamate receptors are expressed on peripheral nerve terminals, and these may contribute to peripheral nociceptive sensation .

Administration of magnesium sulphate via different routes has been used in anaesthetic practice for decreasing perioperative pain. Parenteral magnesium sulphate has been used for many years as an antiarrhythmic agent and for seizure prophylaxis in eclampsia and preeclampsia. It is N-methyl d-aspartate (NMDA) receptor antagonist and suppresses these receptor induced inflammation and hyper responsiveness . The antinociceptive effect of magnesium sulphate is not only useful in chronic pain, but it also determines in part, the duration and intensity of postoperative pain . These effects are due to calcium antagonism and decrease influx of calcium into the cell and antagonism of NMDA receptor. As these receptors regulate neuronal signalling and are involved in pain processing, magnesium sulphate by blocking this receptor, decreases postoperative pain as well .

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Comparison Of Intraperitoneal Instillation Of Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia In Laparoscopic Surgeries In Pediatrics
• Actual Study Start Date: April 4, 2019
• Actual Primary Completion Date: June 15, 2020
• Actual Study Completion Date: November 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Parenteral Analgesia; receive ordinary analgesics via intravenous route as paracetamol (7.5- 10 mg/kg) and ketorolac (0.5 mg/kg).	Drug: paracetamol & ketorolac; parenteral analgesics
Active Comparator: Intraperitoneal instillation; receive (Magnesium sulphate 40 mg/kg and bupivacaine 4mg/kg) in 30 ml of isotonic 0.9%N.S intra peritoneal at the end of surgery.	Drug: Magnesium Sulfate & bupivacaine; intraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine

Outcome Measures

Primary Outcome Measures :

1. FLACC score [ Time Frame: 0 minutes (immediately) postoperative ]
   (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.
2. FLACC score [ Time Frame: 1 hour postoperative ]
   (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.
3. FLACC score [ Time Frame: 6 hours postoperative ]
   (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.
4. FLACC score [ Time Frame: 12 hours postoperative ]
   (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.
5. FLACC score [ Time Frame: 24 hours postoperative ]
   (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.

Secondary Outcome Measures :

1. Vital signs [ Time Frame: preoperative, postoperative (0,1,3,6,12,24 hours) ]
   Heart rate
2. Vital signs [ Time Frame: preoperative, postoperative (0,1,3,6,12,24 hours) ]
   Arterial blood pressure
3. Vital signs [ Time Frame: preoperative, postoperative (0,1,3,6,12,24 hours) ]
   Arterial Oxygen saturation
4. Time to first analgesic administration [ Time Frame: 24 hours postoperative ]
   Time to first analgesic administration
5. Total analgesic requirements [ Time Frame: 24 hours postoperative ]
   Total analgesic requirements in 24 hours postoperative

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. ASA physical status I-II.
2. Both genders are eligible for study.
3. Patients age from 1 year to 12 years.
4. Patients undergoing laparoscopic surgeries.

Exclusion Criteria:

• 1- ASA III, IV and V class patients. 2- Presence of psychiatric disease. 3- Those with an allergy to any of the study drugs will be excluded from the study.

Contacts and Locations

Locations

Egypt

Menoufia university

Menoufia, Egypt

Sponsors and Collaborators

Menoufia University

More Information

• Responsible Party: Ibrahim Walash, assistant lecturer, Menoufia University
• ClinicalTrials.gov Identifier: NCT04651556
• Other Study ID Numbers: Intraperitoneal anesthesia
• First Posted: December 3, 2020
• Last Update Posted: December 8, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ibrahim Walash, Menoufia University:

intraperitoneal, laparoscopic surgeries, pediatrics

Additional relevant MeSH terms:

Acetaminophen; Ketorolac; Magnesium Sulfate; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Tocolytic Agents; Reproductive Control Agents