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

NCT03643666 | Unknown Phase 3

• 1 other identifier: N-9-2018
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative nausea and vomiting

  first 24 hours

• Heart rate

  first 24 hours

• arterial blood pressure measurement postoperative

  first 24 hours

• doses of consumed postoperative analgesics

  first 24 hours

Study Arms (3)

control group

PLACEBO COMPARATOR

this group will include 25 patients receiving intraperitoneal 40 ml of normal saline only at the end of laparoscopic cholecystectomy

Drug: Placebo (saline)

dexamethasone group

ACTIVE COMPARATOR

this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone in 40 ml saline at the end of laparoscopic cholecystectomy

Drug: dexamethasone

dexamethasone plus magnesium sulphate group

ACTIVE COMPARATOR

this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone plus 2 gm magnesium sulphate at the end of laparoscopic cholecystectomy

Drug: dexamethasone; Drug: magnesium sulphate

Interventions

dexamethasone DRUG

before closure of the laparoscopic entering sites the patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone

dexamethasone group; dexamethasone plus magnesium sulphate group

magnesium sulphate DRUG

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

dexamethasone plus magnesium sulphate group

Placebo (saline) DRUG

before closure of the laparoscopic entering sites the patients received instillation of 40 ml normal saline into the peritoneum

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Age \< 18 years or \> 60 years
• ASA physical status III or IV
• Patients with diabetes
• Patient refusal to participate in the study
• Chronic respiratory disease
• Advanced renal or hepatic diseases
• Use of opioids, tranquilizers or steroids
• Confusion or psychiatric illness
• Acute cholecystectomy
• Patients with peritoneal drain after surgery

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alaini hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Magnesium Sulfate; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 23, 2018
• Study Start: October 27, 2018
• Primary Completion: January 30, 2019
• Study Completion: March 1, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

EG (1)