Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic Cholecystectomy

Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic cholecystectomY

Laparoscopic cholecystectomy has become a standard technique for gall bladder surgery. Benefits in comparison to conventional laparotomy are shorter lived effects on pulmonary function and less postoperative pain . However, patients often suffer from considerable pain during the first 24 postoperative hours. Pain can prolong hospital stay and lead to increased morbidity, which is particularly important now that many centers are performing this operation as a day-case procedure. Administration of intraperitoneal local anesthetic, either during or after surgery, is used by as a method of reducing postoperative pain. Although a number of studies have reported a significant reduction in postoperative pain after the use of intraperitoneal analgesia, others have reported no benefit. Several investigations have been conducted in order to find the cause of this pain. According to some of these investigations, the pain is attributed to peritoneal inflammation due to carbon dioxide pneumoperitoneum. Since steroids have been used for reducing inflammation, they may be considered as alternatives for relieving pain. Dexamethasone is a strong long acting glucocorticoid and it is widely used after surgery. it has been established that steroids are effective in relieving postoperative pain in laparoscopic cholecystectomy. Also, administration of magnesium sulphate has been shown to have a potential to prevent postoperative pain and to reduce intra operative anesthetic and analgesic requirements being an antagonist of N-methyl-D-aspartate (NMDA) receptors and its associated ion channels. Some studies showed reduction of pain scores if magnesium sulphate was injected intra-articular and intraperitoneal with no serious adverse effects. In this study the investigators will use intraperitoneal dexamethasone vs dexamethasone plus magnesium sulphate to study their analgesic efficacy after laparoscopic cholecystectomy as the investigators assume that the combination of both drugs will provide stronger analgesia than dexamethasone alone

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Placebo (saline); Drug: dexamethasone; Drug: magnesium sulphate

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alaini hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age group and gender: between 18 to 60 years both males and females
2. American Society of Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

1. Age < 18 years or > 60 years
2. ASA physical status III or IV
3. Patients with diabetes
4. Patient refusal to participate in the study
5. Chronic respiratory disease
6. Advanced renal or hepatic diseases
7. Use of opioids, tranquilizers or steroids
8. Confusion or psychiatric illness
9. Acute cholecystectomy
10. Patients with peritoneal drain after surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; this group will include 25 patients receiving intraperitoneal 40 ml of normal saline only at the end of laparoscopic cholecystectomy	Drug: Placebo (saline); before closure of the laparoscopic entering sites the patients received instillation of 40 ml normal saline into the peritoneum
Active Comparator: dexamethasone group; this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone in 40 ml saline at the end of laparoscopic cholecystectomy	Drug: dexamethasone; before closure of the laparoscopic entering sites the patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone
Active Comparator: dexamethasone plus magnesium sulphate group; this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone plus 2 gm magnesium sulphate at the end of laparoscopic cholecystectomy	Drug: dexamethasone; before closure of the laparoscopic entering sites the patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone; Drug: magnesium sulphate; patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone plus magnesium sulphate 2 gm into the peritoneum at the end of the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain: VAS	Postoperative pain scoring using standard Visual Analogue Scale (VAS) pain score of 0-10 (with 0 meaning no pain and 10 meaning the most intense pain ever experienced)	first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting	Postoperative nausea and vomiting using simplified simplified postoperative nausea and vomiting (PONV) impact scale which is measured through two questions as following: Q1. Has the patient vomited or had dry-retching? 0. No; Once; Twice; Three or more times Q2. Has the patient experienced a feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit)? If yes, has the feeling of nausea interfered with activities of daily life, such as being able to get out of bed, being able to move about freely in bed, being able to walk normally, or eating and drinking? 0. Not at all; Sometimes; Often or most of the time; All of the time. To calculate the PONV Impact Scale, the numerical responses to questions 1 and 2 will be added. Several vomits or dry-retching events occurring over a short time frame e.g 5 min, will be counted as one vomiting/dry-retching episode.	first 24 hours
Heart rate		first 24 hours
arterial blood pressure measurement postoperative	systolic and diastolic blood pressure	first 24 hours
doses of consumed postoperative analgesics		first 24 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2018
• Primary Completion (Actual): January 30, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 3, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Dexamethasone; Magnesium Sulfate
• Other Study ID Numbers: N-9-2018

Drug and device information, study documents

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