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.: PACTR201802002939228 Date of Approval: 02/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative study of the analgesic effect of Ultrasound-guided Transversus Abdominis and ErectorSpinae Plane Blocks in laparscopic Bariatric surger
Official scientific title A Comparative study of the analgesic effect of Ultrasound-guided Transversus Abdominis and ErectorSpinae Plane Blocks in laparscopic Bariatric surgeries.
Brief summary describing the background and objectives of the trial Background:several methods of postoperative analgesia can be used in bariatric surgery. opioid analalgesia carry the risk of respiratory depression, There are several advantages to using epidural anesthesia for laparoscopic bariatric surgery. First, preoperative pulmonary functions may be maintained through out the surgery. Secondly, the risk of deep venous thrombosis and pulmonary embolism is lower with epidural anesthesia than with general anesthesia. There are some limitations in using epidural anesthesia for Laparoscopic bariatric surgery because of difficulty in performing the anesthetic technique in morbidly obese patients also conversion to general anesthesia may be considered with intolerable shoulder pain or long surgery time.Paravertebral block is also tried in Laparscopic bariatric surgery but the risk of pneumothorax, intra thecal or epidural spread limit its use, also the risk of respiratory insufficiency if bilateral paravertebral block is combined with superficial cervical plexus block to relieve shoulder pain with the risk of phrenic nerve block.Transversus Abdominis plane block (TAP) is a relatively new peripheral nerve block described to anesthetize the nerves supplying anterior abdominal wall (T6-T12). It's a simple procedure that can be used as adjunct for pain control in abdominal , Gynecologic and urologic surgeries. In bariatric surgery, dull visceral pain from spasm or inflammation after surgery will still occur because TAP block like other abdominal wall blocks will block somatic pain only. Local anaesthetic injected deep to erector spinae muscle and spreads craniocaudally over many levels. Unlike TAP block (ESP) block can block both visceral and somatic pain in abdominal operations. Objective:to compare ESP block with TAP block as an adjunct to general anaesthesia in Laparscopic bariatric surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,regional, analgesia, bariatric, surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 07/12/2017
Actual trial start date 09/12/2017
Anticipated date of last follow up 06/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 79
Actual target sample size (number of participants) 72
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ZU-IRB #4148-6-12-2017 ZAGAZIG UNIVERSITY MEDICAL FACULTY
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 radomisation table created by a 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
Control Group Group (A) transversus abdominis plae (TAP) Block group Patients will receive bilateral us guided subcostal TAP block 20ml of 0.25% Bupivacaine will be injected each side and over ¿ needle preipheral of resume catheter set will be insets and the catheter i 24 hours General anesthesia will be induced using propofol 2 mg/kg I.V fentanyl 1-2 mg/kg I.V and rocunonium 0.6mg/kg I.V Then endotracheal intubation will be done maintaince of anesthesia will be viaISO flurane inhalation 2-2,5% in 40: 60 oxygan and airmixure. Positive pressure ventilation will be started with rate and Tidalvolume adjusted to maintain am end tidal Co2 30-40mmHg while in the supine posit 36 Active-Treatment of Control Group
Experimental Group Group (B) erector spinae plane (ESP) block group Patients will receive bilateral us-guided ESP block, 20ml of 0.25% Bupivacaine are injected in each side. An over-needle peripheral nerve catheter is fixed for maintenance doses in the form of 8 ml Bu 24 hours After induction of general anaesthesia and sterilization of the field, Identification of transnerse process of T7 via scanning and counting the ribs by U/s guidance from the 1st rib and put a mark down to the 7th rib. The transverse process tip is marked by transverse scan then the transducer is tilted to be parasagittal and the trapezius and erector spinaemusdes are obvious above the transverse p 36
Experimental Group Group (B) erector spinae plane (ESP) block group Patients will receive bilateral us-guided ESP block, 20ml of 0.25% Bupivacaine are injected in each side. An over-needle peripheral nerve catheter is fixed for maintenance doses in the form of 8 ml Bu 24 hours After induction of general anaesthesia and sterilization of the field, Identification of transnerse process of T7 via scanning and counting the ribs by U/s guidance from the 1st rib and put a mark down to the 7th rib. The transverse process tip is marked by transverse scan then the transducer is tilted to be parasagittal and the trapezius and erector spinaemusdes are obvious above the transverse p 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I- III 18 ¿ 70 years of age scheduled for elective laparscopic (ROUEX EN Y_SLEEVE GASTRECTOMY) Patent refusal CI to regional anaesthesia (e.g, allergy to local anesthetics, coagulopathy, infection ) History of psychic troubles Pregnancy History of long term opioid intake or chronic pain disorders Disturbed conscious level sever respiratory diseases 18 Year(s) 70 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 06/12/2017 Zagazig University medical faculty
Ethics Committee Address
Street address City Postal code Country
ZAGAZIG UNIVERSITY ZAGAZIG 4419 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total analgesic (mg morphine iv) consumption intra operative and in the 1st 24hs post operative In the operative rescue morphine will be given according to hemodynamic changes (increase in HR and BP above 20% of base line reading) post operative rescue morphine will be given according to NRS (numerical rating scale ) to achieve a clinical forget of 4/10 or lower on NRS for pain Total analgesic (mg morphine iv) consumption intra operative and in the 1st 24hs post operative In the operative rescue morphine will be given according to hemodynamic changes (increase in HR and BP above 20% of base line reading) post operative rescue morphine will be given according to NRS (numerical rating scale ) to achieve a clinical forget of 4/10 or lower on NRS for pain
Secondary Outcome complications Occurrence of regional block complications including local anesthetic toxicity, vascular injury, visceral injury and respiratory problems) will be recorded.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
zagazig university hospitals zagazig university zagazig 44519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ZAGAZIG UNIVERSITY HOSPITALS ZAGAZIG UNIVERSITY ZAGAZIG 44519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ZAGAZIG UNIVERSITY HOSPITALS ZAGAZIG UNIVERSITY ZAGAZIG 44519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
OSAMA YEHIA AHMAD KHALIFA ANESTHESIA DEPARTMENT ZAGAZIG MEDICAL FACULTY ZAGAZIG UNIVERSITY ZAGAZIG 44519 Egypt
Fatma Mahmoud Ahmed ANESTHESIA DEPARTMENT ZAGAZIG MEDICAL FACULTY ZAGAZIG UNIVERSITY ZAGAZIG 44519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OSAMA YEHIA A. KHALIFA yehia2001@hotmail.com 00201007579438 ANESTHESIA DEPATMENT, ZAGAZIG MEDICAL FACULTY, ZAGAZIG UNIVERSITY
City Postal code Country Position/Affiliation
ZAGAZIG 44519 Egypt LECTURER
Role Name Email Phone Street address
Public Enquiries OSAMA YEHIA A. KHALIFA yehia2001@hotmail.com 00201007579438 ANESTHESIA DEPATMENT, ZAGAZIG MEDICAL FACULTY, ZAGAZIG UNIVERSITY
City Postal code Country Position/Affiliation
ZAGAZIG 44519 Egypt LECTURER
Role Name Email Phone Street address
Scientific Enquiries OSAMA YEHIA A. KHALIFA yehia2001@hotmail.com 00201007579438 ANESTHESIA DEPATMENT, ZAGAZIG MEDICAL FACULTY, ZAGAZIG UNIVERSITY
City Postal code Country Position/Affiliation
ZAGAZIG 44519 Egypt LECTURER
REPORTING
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