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.: PACTR202203570043004 Date of Approval: 30/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Intraoperative Lung Recruitment and Transversus Abdominis Plane Block in Laparoscopic Bariatric Surgery on Postoperative Lung Functions
Official scientific title Effect of Intraoperative Lung Recruitment and Transversus Abdominis Plane Block in Laparoscopic Bariatric Surgery on Postoperative Lung Functions
Brief summary describing the background and objectives of the trial Morbid obesity can promote a restrictive syndrome due to accumulation of perithoracic and abdominal fat. GA and the supine position lead to a reduction in lung volume and functional residual capacity, favoring the development of atelectasis and changing ventilation/perfusion ratio and increasing the pulmonary shunt. Lung recruitment maneuver (RM) as a ventilatory strategy has been used to improve gas exchange during anesthesia which consists of pulmonary inflations and sustained use of positive end expiratory pressure (PEEP) to prevent atelectasis and reduce postoperative pulmonary complications in patients undergoing laparoscopic bariatric surgery. The aim of RM is reopening of collapsed alveolar units, increasing lung area available for gas exchange and improving arterial oxygenation in patients undergoing abdominal, thoracic or laparoscopic surgery and in patients prone to developing moderate degrees of lung injury after surgical procedures. RM is a safe and effective technique when used for prevention of pulmonary complications in patients undergoing laparoscopic bariatric surgery, evidenced by the best spirometric values and radiographic findings post operatively. Despite the minimally invasive nature of laparoscopic bariatric surgery, pain can be moderate to severe in the immediate postoperative period. Pain control in morbidly obese can be challenging because of increased sensitivity to opioid-induced respiratory depression. The transversus abdominis plane (TAP) block has been demonstrated to improve pain-related outcomes after upper and lower abdominal surgical procedures and reduce opioid consumption after laparoscopic bariatric surgery when added to conventional analgesic techniques
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/04/2018
Actual trial start date 08/08/2018
Anticipated date of last follow up 04/04/2019
Actual Last follow-up date 10/10/2019
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standarized postoperative analgesia regimen. After tracheal intubation, lungs ventilated using volume-controlled ventilation with TV 6:8ml/kg of IBW and 6:8 cmH2O PEEP applied in all patients.. All patients recevied standarized postoperative analgesia regimen consisting of paracetamol 1gm/6h IV and morphine 1mg increments IV 1st 24h postoperative After tracheal intubation, lungs ventilated using volume-controlled ventilation with TV 6:8ml/kg of IBW and 6:8 cmH2O PEEP applied in all patients.. All patients recevied standarized postoperative analgesia regimen consisting of paracetamol 1gm/6h IV and morphine 1mg increments IV 20 Active-Treatment of Control Group
Experimental Group patients received TAP block after intubation and before surgical incision Thirty ml of 0.25% bupivacaine with 1:200,000 epinephrine will be injected in each side. After intubation and before surgical incision TAP block administrated immediately after induction of anesthesia and prior to surgical incision, using oblique subcostal approach, under sterile conditions, a high frequency linear array trasducer positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transversus abdominis muscles would be identified immediately lateral to the linea semilunaris. A 22-G, 80-mm, short bevel echogenic needle inserted medially and in plane to the ultrasound (US) beam until the tip lies between the fascia of the internal oblique and the transversus abdominis musle layer. Thirty ml of 0.25% bupivacaine with 1:200,000 epinephrine will be injected in each side. 20
Experimental Group patients received RM after intubation and after pneumoperitoneal exsufflation. Two RMs consisting of maintaining the airway pressure at 40 cmH2O during 40 s performed after tracheal intubation and after pneumoperitoneal exsufflation. After tracheal intubation and after pneumoperitoneal exsufflation. Two RMs consisting of maintaining the airway pressure at 40 cmH2O during 40 s performed after tracheal intubation and after pneumoperitoneal exsufflation. 20
Experimental Group patients received RM and TAPblock Two RMs consisting of maintaining the airway pressure at 40 cmH2O during 40 s performed after tracheal intubation and after pneumoperitoneal exsufflation. TAP block administrated immediately after induction of anesthesia and prior to surgical incision, using oblique subcostal approach, Thirty ml of 0.25% bupivacaine with 1:200,000 epinephrine will be injected in each side. Patients who received RM after intubation and after pneumoperitoneal exsufflation and TAP block after intubation and before surgical incision . Two RMs consisting of maintaining the airway pressure at 40 cmH2O during 40 s performed after tracheal intubation and after pneumoperitoneal exsufflation. TAP block administrated immediately after induction of anesthesia and prior to surgical incision, using oblique subcostal approach, Thirty ml of 0.25% bupivacaine with 1:200,000 epinephrine will be injected in each side. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients with American Society of Anesthesiologists (ASA) physical status of I or II. • Age between 18-55 years. • Elective laparoscopic bariatric surgery under general anesthesia • Refusal of the patient. • ASA status more than II. • Patients age <18 or >55 years. • Patients with major obstructive and restrictive pulmonary diseases (<50% of predicted values for PFT varibles). • Patients with advanced renal or hepatic disease. • Patients who will need postoperative ventilatory support. • Patients with alcohol or drug dependence/abuse. • Contraindication to peripheral nerve block (coagulopathy, infection at the site, allergy to local anesthetics). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 04/04/2018 Research Ethics Committee at the faculty of medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Next to EL Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Spirometric values (FVC, FEV1, FEV1/FVC) preoperative and 24h postoperative preoperative and 24h postoperative
Secondary Outcome • Oxygenation: PaO2/FiO2 ratio preoperative, intraoperative, postoperative. preoperative, intraoperative, postoperative.
Secondary Outcome • Hemodynamics: mean arterial pressure (MAP) and heart rate (HR) preoperative, intraoperative, postoperative. preoperative, intraoperative, postoperative.
Secondary Outcome • Cumulative opioid consumption (IV morphine) in 1st 24h postoperative 1st 24h postoperative
Secondary Outcome • Pain severity score using numeric rating scale (NRS). NRS is a 10-point scale with 0 = no pain and 10 = worst imaginable pain. 1st 24h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University 38 Abbassia Square next to AL-Nour Mosque Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aboseif Abdel Hamed Aboseif El-Shorouk city Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams Universty 38 Abbassia Square next to El-Nour Mosque Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Aboseif Abdel Hamed Aboseif El-Shorouk Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aboseif Abdel Hamed Aboseif aboseifabdelhamed@gmail.com +201113557639 EL-Shorouk
City Postal code Country Position/Affiliation
Cairo Egypt assisant lecturer Faculty of medicine Helwan University
Role Name Email Phone Street address
Scientific Enquiries Rafaat Abdel Azim Hammad Rafaat-Abdelazim@med.asu.edu.eg +201223498967 8 Mostafa EL Nahas street Nasrcity
City Postal code Country Position/Affiliation
Cairo Egypt professor of anathesia faculyu of medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Ahmed Abd Elmohsen a.bedewy79@yahoo.com +201061701515 samuha, Alexandria
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of anathesia faculty of medicine Helwan University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of individual participiant data collected during the trial after deidentification Study Protocol following publication any purpose
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