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

• Status: Unknown status
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Magnesium Sulfate

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