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.: PACTR201512001386365 Date of Approval: 09/12/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Rectus sheath analgesia versus thoracic epidural analgesia
Official scientific title THE ANALGESIC EFFICIE­NCY OF ULTRASOUND-GUI­DED RECTUS SHEATH ANA­LGESIA COMPARED WITH ­LOW THORACIC EPIDURAL­ ANALGESIA AFTER ELEC­TIVE ABDOMINAL SURGER­Y WITH MIDLINE INCISI­ON: A PROSPECTIVE RAN­DOMIZED CONTROLLED TR­IAL.
Brief summary describing the background and objectives of the trial This study aimed to compare the analgesic effect of Rectus sheath analgesia with thoracic epidural analgesia after midline incision abdominal surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Postoperative analgesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/12/2014
Actual trial start date 07/01/2015
Anticipated date of last follow up 30/08/2015
Actual Last follow-up date 10/11/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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 Computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Epidural analgesia Group 20 ml of bupivacaine 0.25% plus 2mcg/ml fentanyl then a dose of 8m/hr of the same mixture was given 72 hrs. 29
Experimental Group Rectus sheath analgesia Group 20 ml of bupivacaine 0.25% in each site then every 6 hours 72 hrs. 31
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age ranged between 18 and 60 years. ASA physical status class I, II and III. underwent elective abdominal surgery through a midline incision. known hypersensitivity to local anesthetics. local infection at site of block. hypertensive. obese (BMI >30. Any cardiovascular, cerebro-vascular, renal, hepatic or muscular disease. Patients with coagulation disorders and patients with chronic pain 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 02/10/2014 Benha faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Farid Nada st. Benha 230280 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total morphine consumption 72 hours postoperative
Secondary Outcome Visual analogue scale at rest and during cough Every 6 hours for 72 hours
Secondary Outcome Side effects 72 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha faculty of medicine Farid Nada st. Benha 230280 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha university Farid Nada st. Benha 230280 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha university hospitals Farid Nada st. Beha 230280 Egypt Hospital
Secondary Sponsor Benha university Farid Nada st. Benha 230280 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Surgery department - Benha university Farid Nada st. Benha 230280 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdel Moneim atohamy80@gmail.com 00201008700759
City Postal code Country Position/Affiliation
Qaliob Egypt
Role Name Email Phone Street address
Public Enquiries Ahmed Abd El-Hamid bashaahmad@yahoo.com 00201005204130
City Postal code Country Position/Affiliation
Giza Egypt
Role Name Email Phone Street address
Scientific Enquiries Saad Saad saadibrahim_7@yahoo.com 00201223142889 Oman st.
City Postal code Country Position/Affiliation
Giza Egypt
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