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

NCT ID: NCT03643666

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-27
• Study Completion Date: 2019-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

control group

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

Group Type: PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type: DRUG

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

dexamethasone group

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

Group Type: ACTIVE_COMPARATOR

dexamethasone

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

dexamethasone

Intervention Type: DRUG

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

magnesium sulphate

Intervention Type: 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

Interventions

dexamethasone

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

Intervention Type: 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

Intervention Type: DRUG

Placebo (saline)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

AbdElKhalik Mahmoud Shaban

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alaini hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-9-2018

Identifier Type: -

Identifier Source: org_study_id