Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201708002497386 Date of Approval: 03/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy and Safety of Intraperitoneal Bupivacaine Alone or with Dexmedetomidine on Postoperative Analgesia after Laparoscopic Cholecystectomy
Official scientific title Efficacy and Safety of Intraperitoneal Bupivacaine Alone or with Dexmedetomidine on Postoperative Analgesia after Laparoscopic Cholecystectomy
Brief summary describing the background and objectives of the trial Laparoscopic procedures have become very popular in recent years because of the proven quicker postoperative recovery, lower rates of early and late postoperative complications, early mobilization, and discharge home. (1,2) Laparoscopic cholecystectomy compared to open cholecystectomy is currently the most accepted surgical technique for cholelithiasis. (3) Patients undergoing laparoscopic procedures may experience considerable postoperative pain, which could be an important limiting factor for ambulatory laparoscopic cholecystectomy. Peritoneal inflammation and diaphragmatic irritation by residual Co2 gas probably explains the high incidence of postoperative shoulder pain. (4) Our primary outcome measure is the efficacy of the addition of intraperitoneal dexmedetomidine 1 mcg/kg or 0.5 mcg/kg to bupivacaine 125 mg in postoperative analgesia for patients undergoing elective laparoscopic cholecystectomy under general anesthesia, our secondary outcome measure is the safety of this combination in the first 24 hours postoperatively. As it has been recommended by previous studies to study larger sample size and different doses of dexmedetomidine. (8,10)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/06/2017
Actual trial start date 03/12/2017
Anticipated date of last follow up 03/12/2017
Actual Last follow-up date 03/12/2017
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Patients will be randomly allocated into three groups (40 patients in each group) according to an opaque sealed envelope technique Patients will be randomly allocated into three groups (40 patients in each group) according to an opaque sealed envelope technique Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperit patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperitoneal 5ml normal saline intraperitoneal patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperitoneal 5ml normal saline 40 Active-Treatment of Control Group
Experimental Group patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperit patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperitoneal dexmedetomidine (precede, Hospira) 0.5 mcg/kg in 5 ml normal saline intraperitoneal patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperitoneal dexmedetomidine (precede, Hospira) 0.5 mcg/kg in 5 ml normal saline 40
Experimental Group patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperit patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperitoneal dexmedetomedine (precede, Hospira) 1 mcg/kg in 5 ml normal saline intraperitoneal patients will receive intraperitoneal bupivacaine (sunny marcaine) 50 ml 0.25% (125 mg) + intraperitoneal dexmedetomedine (precede, Hospira) 1 mcg/kg in 5 ml normal saline 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I and II of both sex and Age group18-60 years old) undergoing elective laparoscopic cholecystectomy under general anesthesia. Patients with hypersensitivity or intolerance to the study drugs, severe renal dysfunction, severe hepatic dysfunction where metabolism of the drug may be greatly altered, severe cardiac disease with low cardiac output or conduction abnormalities as heart block, history of psychiatric illness, leaving intra abdominal drain at end of surgery and intraoperative change from laparoscopic to open surgery will be excluded from the study. 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/05/2017 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Postoperative visual analogue score will be recorded immediately postoperative and at 1, 6, 12 and 24 hours ¿ Postoperative visual analogue score will be recorded immediately postoperative and at 1, 6, 12 and 24 hours
Primary Outcome ¿ First time to request analgesia in minutes ¿ First time to request analgesia in minutes postoperaative
Secondary Outcome ¿ Postoperative 24 hours analgesic requirement (pethidine) in mg. Postoperative 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-Suef university hospital BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Mohamed Ibrahim Ahmed BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mohamed Ibrahim Ahmed BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
Samaa Rashwan BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
Gamal Eid Mohamed Eid BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt BeniSuief University hospital,Egypt 000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Ahmed sou_175@yahoo.com 01277355355 BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief University hospital,Egypt 000 Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Samaa Rashwan doaa_rashwan@hotmail.com 01011270763 BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief University hospital,Egypt Egypt assitant professor
Role Name Email Phone Street address
Scientific Enquiries Samaa Rashwan doaa_rashwan@hotmail.com 01011270763 BeniSuief University hospital,Egypt, BeniSuief University hospital,Egypt
City Postal code Country Position/Affiliation
BeniSuief University hospital,Egypt 000 Egypt assitant professor
REPORTING
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