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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03643666
• Other study ID #: N-9-2018
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 27, 2018
• Est. completion date: March 2019

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: March 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• dexamethasone
before closure of the laparoscopic entering sites the patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone
• 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
• Placebo (saline)
before closure of the laparoscopic entering sites the patients received instillation of 40 ml normal saline into the peritoneum

Locations

Country	Name	City	State
Egypt	Kasr Alaini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Heart rate		first 24 hours
Secondary	arterial blood pressure measurement postoperative	systolic and diastolic blood pressure	first 24 hours
Secondary	doses of consumed postoperative analgesics		first 24 hours