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

Phase 4

Completed

• Conditions: Intraperitoneal Magnesium Sulphate in Laparoscope in Pediatrics
• Interventions: Drug: paracetamol & ketorolac; Drug: Magnesium Sulfate & bupivacaine

• Registration Number: NCT04651556
• Lead Sponsor: Menoufia University

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.

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 Timeline

• Study Start: 2019-04-04
• Primary Completion: 2020-06-15
• Study First Submitted: 2020-11-12
• Study Completion: 2020-11-15
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parenteral Analgesia	paracetamol & ketorolac	receive ordinary analgesics via intravenous route as paracetamol (7.5- 10 mg/kg) and ketorolac (0.5 mg/kg).
Intraperitoneal instillation	Magnesium Sulfate & bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
FLACC score	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

Name	Time	Method
Vital signs	preoperative, postoperative (0,1,3,6,12,24 hours)	Arterial Oxygen saturation
Time to first analgesic administration	24 hours postoperative	Time to first analgesic administration
Total analgesic requirements	24 hours postoperative	Total analgesic requirements in 24 hours postoperative

Trial Locations

Locations (1)

Menoufia university; 🇪🇬 Menoufia, Egypt