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

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: dexamethasone; Drug: Placebo (saline); Drug: magnesium sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT03643666

N-9-2018

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (saline)

dexamethasone group

Active Comparator group

Description:

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

Treatment:

Drug: dexamethasone

dexamethasone plus magnesium sulphate group

Active Comparator group

Description:

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

Treatment:

Drug: magnesium sulphate

Drug: dexamethasone