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.: PACTR201804002608316 Date of Approval: 11/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study of Segmental thoracic Spinal versus thoracic epidural anaethesia for laparoscopic cholecystetomy.
Official scientific title Comparative Study of Segmental thoracic Spinal versus thoracic epidural anaethesia for laparoscopic cholecystetomy.
Brief summary describing the background and objectives of the trial This study designed to compare and evaluate safety,efficacy and complication of conducting laparoscopic cholecystectomy under segmental thoracic spinal versus thoracic epidural anesthesia. Patients and methods: The study will be conducted in Beni Suef university hospital, after approval from the local ethical committee and an informed consent for any one of the two techniques of anesthesia was obtained from all patients and informed about the probability of conversion to general anesthesia if needed. Inclusion Criteria include: ¿ ASA physical status I & II. ¿ Male or female patient aged 18¿60 years. Exclusion Criteria include: ¿ Patient refusal. ¿ Acute cholecystitis, pancreatitis or cholangitis. ¿ Prior laparotomy for upper abdominal surgery. ¿ Contraindication for spinal or epidural anesthesia e.g.coagulopathy. ¿ Body mass index >32 kg/m2 ¿ Chronic obstructive pulmonary disease. Methodology All patients will be monitored with noninvasive blood pressure, oxygen saturation, and ECG and pre operative reading will be obtained, an 18-G catheter will be inserted in the left hand for hydration and administration of drugs. Initially, 500 mL of Ringer's lactate , cephalosporin 2 g, ranitidine 50 mg and metochlopramide 10 mg,ondansetrone 4or 8 mg IV before the blockade fentanyl (50µ) and midazolam (2 mg) Will be administered before the puncture. InTSA group with the patient in sitting position, after establishing aseptic conditions, skin wheal is raised at the level of the chosen interspace with local anesthetic using a small (25-gauge) needle, a 25-G pencil-point needle will be inserted into the subarachnoid space at T8/T9 interspace (TSAgroup, 7.5 mg isorbaric bupivacaine 0.5% and 25 µg fentanyl will be injected with total volume 2ml ). Afterwards, patients will be placed in the supine position .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,anathesia, epidural, spinal,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/10/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 01/10/2017
Actual Last follow-up date 02/10/2017
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Stopped early/ terminated
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 Simple randomisation using a randomisation table from a statistics book Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group thoracic spinal anathesia thoracic spinal vs thoracic epidural anathesia 35 Uncontrolled
Experimental Group thoracic epidural anathesia method for anathesia in surgical procedure for gall blader 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I & II. Male or female patient aged 18¿60 years. ¿ Patient refusal. ¿ Acute cholecystitis, pancreatitis or cholangitis. Prior laparotomy for upper abdominal surgery. Contraindication for spinal or epidural anesthesia e.g.coagulopathy. Body mass index >32 kg/m2 Chronic obstructive pulmonary disease. 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 15/05/2016 Ethics committee of Faculty of Medicine Beni Suef university (FM-BSU REC)
Ethics Committee Address
Street address City Postal code Country
Beni suef university Beni suef 0020 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome pain control intra and post operative anthesia pain control intra and post operative anthesia
Primary Outcome alternative methods for anathesia alternative methods for anathesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef University Faculty of medicine Salah Salem st. Beni Suef 0020 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Beni suef university Beni Suef Beni Suef 0020 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni suef university Beni Suef Beni Suef 0020 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Beni suef university Beni Suef Beni Suef 0020 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem El Moutaz Mahmoud helmoutaz@yahoo.com 01001716514 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef 0020 Egypt
Role Name Email Phone Street address
Public Enquiries Hazem Abd Elwahab hazemwahab@yahoo.com 01001716514 Beni Suef
City Postal code Country Position/Affiliation
Beni suef 0020 Egypt
Role Name Email Phone Street address
Scientific Enquiries Jehan Mohamed jehanmohamed1510@gmail.com 01110269572 Beni Suef
City Postal code Country Position/Affiliation
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information