Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic Cholecystectomy
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
dexamethasone
magnesium sulphate
Placebo (saline)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Age group and gender: between 18 to 60 years both males and females
- American Society of Anesthesiologists (ASA) physical status I-II
Exclusion Criteria:
- 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
Sites / Locations
- Kasr Alaini hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
control group
dexamethasone group
dexamethasone plus magnesium sulphate group
Arm Description
this group will include 25 patients receiving intraperitoneal 40 ml of normal saline only at the end of laparoscopic cholecystectomy
this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone in 40 ml saline at the end of laparoscopic cholecystectomy
this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone plus 2 gm magnesium sulphate at the end of laparoscopic cholecystectomy
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Heart rate
arterial blood pressure measurement postoperative
systolic and diastolic blood pressure
doses of consumed postoperative analgesics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03643666
Brief Title
Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic Cholecystectomy
Official Title
Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic cholecystectomY
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 27, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
this group will include 25 patients receiving intraperitoneal 40 ml of normal saline only at the end of laparoscopic cholecystectomy
Arm Title
dexamethasone group
Arm Type
Active Comparator
Arm Description
this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone in 40 ml saline at the end of laparoscopic cholecystectomy
Arm Title
dexamethasone plus magnesium sulphate group
Arm Type
Active Comparator
Arm Description
this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone plus 2 gm magnesium sulphate at the end of laparoscopic cholecystectomy
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
before closure of the laparoscopic entering sites the patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
magnesium sulphate
Intervention Description
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
Intervention Name(s)
Placebo (saline)
Intervention Description
before closure of the laparoscopic entering sites the patients received instillation of 40 ml normal saline into the peritoneum
Primary Outcome Measure Information:
Title
Postoperative pain: VAS
Description
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)
Time Frame
first 24 hours
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
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.
Time Frame
first 24 hours
Title
Heart rate
Time Frame
first 24 hours
Title
arterial blood pressure measurement postoperative
Description
systolic and diastolic blood pressure
Time Frame
first 24 hours
Title
doses of consumed postoperative analgesics
Time Frame
first 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age group and gender: between 18 to 60 years both males and females
American Society of Anesthesiologists (ASA) physical status I-II
Exclusion Criteria:
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
Facility Information:
Facility Name
Kasr Alaini hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic Cholecystectomy
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