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.: PACTR201706002388985 Date of Approval: 28/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Erector spinae plan block
Official scientific title Ultrasound-guided erector spinae block in patients undergoing laparoscopic bariatric surgery
Brief summary describing the background and objectives of the trial Despite the minimally invasive nature of LGBS, pain can be moderate to severe in the immediate postoperative period. Further, pain control in the morbidly obese can be especially challenging because of increased sensitivity to opioid-induced respiratory depression. Ultrasound-guided erector spinae plane block (ESPB) is a recently described technique for providing thoracic analgesia. Cadaveric investigation indicates that injection of 20ml solution into the fascial plane deep to the erector spinae muscle at the level of T5 transverse process can result in injectate spread between the C7 and T8 vertebral levels. Given that the erector spinae muscle extends inferiorly to the lumbar spine, injection into the erector spinae plane (ESP) at a lower vertebral level(eg T7 or T8) should result in spread to the lower thoracoabdominal nerves that innervate the abdomen. In addition, because the mechanism of action of the ESPB involves penetration of local anesthetic into the thoracic paravertebral space, it anesthetizes not only the ventral rami of spinal nerves but also the rami communicantes that contain sympathetic nerve fibers. The ESPB thus has the potential to provide both somatic and visceral sensory blockade which would make it an ideal regional anesthetic technique for abdominal surgery. The aim of the present study will be to evaluate the analgesic efficacy of ESPB in morbid obese patients undergoing laparoscopic bariatric surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Postoperative pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2017
Actual trial start date 05/08/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date
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
31509/04/17 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
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 Permuted block randomisation Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group general anesthesia with preoperative sham ultrasound-guided bilateral ESPB once sham bilateral ESPB 30 Placebo
Experimental Group ESPB Group 20ml bupivacaine 0.25% once preoperative Bilateral ESPB 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ages 18-65 yrs; body mass index (BMI) of more than 40 kg/m2; ASA physical status II-III undergoing laparoscopic bariatric surgery allergy to any of the study drugs: coagulation disorders; psychiatric or uncooperative patients; patients with hepatic or renal dysfunction; Patients with history of uncontrolled respiratory / cardiovascular morbidity; Pregnant ladies 18 Year(s) 65 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 01/04/2017 Tanta University Faculty of Medicine Research Ethics Committee Qualtiy Assurance Unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish Street Tanta 31951 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative VAS At admission to the post anesthesia care unit, 30min, 1h, 2h, 4h, 8h, 12, 18 and 24hrs postoperative
Secondary Outcome consumption of intraoperative fentanyl once at end of surgery
Secondary Outcome postoperative rescue analgesia once after 24hrs postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish Street Tanta 31951 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta Universtiy, Faculty of Medicine 10 Algeish Street Tanta 31951 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dept of Anesthesia and Surgical ICU, Tanta Univ Hosp 10 Algeish Street Tanta 31951 Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish Street Tanta 31951 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra 31951 Egypt
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Mohamed Shebl Abdelghani 9 Abdelgleeb Altaweb Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra 31951 Egypt Lecturer of Anesthesia and ICU, Faculty of Medicine, Tanta University
Role Name Email Phone Street address
Public Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and ICU. Faculty of Medicine, Tanta University
Role Name Email Phone Street address
Public Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of Anesthesia and ICU, Faculty of Medicine, Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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