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

Overview

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.

Full Title of Study: “Comparison Of Intraperitoneal Instillation Of Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia In Laparoscopic Surgeries In Pediatrics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: June 15, 2020

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 .

Interventions

  • Drug: Magnesium Sulfate & bupivacaine
    • intraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine
  • Drug: paracetamol & ketorolac
    • parenteral analgesics

Arms, Groups and Cohorts

  • Active Comparator: Parenteral Analgesia
    • receive ordinary analgesics via intravenous route as paracetamol (7.5- 10 mg/kg) and ketorolac (0.5 mg/kg).
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Menoufia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ibrahim Walash, assistant lecturer – Menoufia University

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