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.: PACTR202103492888628 Date of Approval: 04/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector spinae plane block for sleeve gastrectomy
Official scientific title Erector spinae plane block reduces analgesic consumption after sleeve gastrectomy: randomized controlled study
Brief summary describing the background and objectives of the trial Pain following bariatric surgery is troublesome, and despite the laparoscopic approach, up to 42% of patients undergoing laparoscopic Bariatric surgery experience severe pain. Somatic pain from the laparoscopic port sites can be treated with local anesthetic infiltration; however, visceral epigastric pain can be more difficult to manage. The use of opioids is limited by concerns regarding patient somnolence at emergence, as well as postoperative respiratory depression, particularly given the high prevalence of obstructive sleep apnea in this population, opioid-related adverse effects like paralytic ileus, nausea, and vomiting. NSAIDs are often avoided due to reported associations with gastrointestinal anastomotic leaks 5 and the development of marginal ulcers, although the risk from a single dose is unclear. Regional anesthesia techniques offer good pain relief, reduce perioperative opioid and anesthetic use, reduces postoperative nausea/vomiting, helps in reducing chronic pain, and facilitates early rehabilitation. Subcostal transversus abdominis plane blocks have not been shown to offer any additional benefit over systemic multimodal analgesia in this patient population, possibly because of the fact that TAP blocks provide only somatic analgesia. The erector spinae plane block is a newly defined regional anesthesia technique for thoracic analgesia. Its use for other indications, such as abdominal and thoracic surgery, has also recently been reported. In this technique, the local anesthetic injection is performed beneath the erector spinae muscle. Local anesthetic expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally. While a similar analgesic effect might be obtained with a thoracic epidural or bilateral paravertebral blocks, the ESP block offers significant advantages in terms of ease of performance and safety. The transverse processes of the thoracic vertebrae and the erector spinae muscles are easily identified even
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/02/2021
Actual trial start date
Anticipated date of last follow up 05/08/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Erector spinae plane block 30 ml 0.25% bupivacaine single injection Induction of anesthesia will be performed by fentanyl 1 mcg/kg, Propofol 2 mg/kg followed by rocuronium bromide 0.6 mg/kg. Maintenance of anesthesia will be carried out by desflurane varying its end-tidal concentration to keep BIS in the range of 50, and rocuronium bromide 0.2 mg/kg guided neuromuscular monitor. US-guided ESPB technique will be done as follows: With the patient in the lateral position, T7 spinous process will be identified and marked after counting down from C7 spinous process. A low frequency (2-5MHz) curved-array ultrasound transducer will be placed in craniocaudal orientation in the midline, and then it will be moved laterally to identify T7 transverse process. ESM, and trapezius muscle will be identified. 10 cm block needle will be introduced in-plane craniocaudally under vision and navigated till the TP was encountered. Hydro dissection with 2 ml normal saline will be done to confirm separation of ESM from TP, then 30 ml 0.25% bupivacaine will be injected and drug spread will be seen in the ESP plane on both sides craniocaudally in real-time. All patients will receive IV paracetamol 1 g over 10 min and ondansetron 4 mg 30 min before anticipated extubation time. Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings will be managed by fentanyl 0.5 mcg/kg . After emergence from anesthesia, an analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h) and ketorolac 30mg iv every 12 hrs will be used in all groups. After recovery patients will be transferred to high dependency unit, will be kept in a semi-sitting position, and will be fully monitored for 24 hours.Spo2 below 90% will be managed with supplemental O2 via nasal cannula or CPAP/NIV according to the condition of the patient. All patients will be encouraged for early mobilization when tolerated, and will receive prophylactic LMWH 8–12 h after surgery. 30
Experimental Group Transversus Abdominis Plane Block 30 ml of 0.25% bupivacaine single injection Induction of anesthesia will be performed by fentanyl 1 mcg/kg, Propofol 2 mg/kg followed by rocuronium bromide 0.6 mg/kg. Maintenance of anesthesia will be carried out by desflurane varying its end-tidal concentration to keep BIS in the range of 50, and rocuronium bromide 0.2 mg/kg guided neuromuscular monitor. US-guided TAP block will be done as follows: With the patient in the supine position, Using a high frequency (7-12 MHZ) linear -array ultrasound transducer, 10 cm block needle will be inserted using an in-plane approach in the anterior axillary line between the internal oblique and the transverses abdominis muscle. After careful aspiration, 30 ml of 0.25% bupivacaine will be injected in the fascial plane and will be observed to spread between the two layers on either side for a bilateral TAP block. All patients will receive IV paracetamol 1 g over 10 min and ondansetron 4 mg approximately 30 min before anticipated extubation time. Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2–3 min will be managed by fentanyl 0.5 mcg/kg.After emergence from anesthesia, an analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h) and ketorolac 30mg iv every 12 hrs will be used in all groups. After recovery patients will be transferred to high dependency unit, will be kept in semi-sitting position, and will be fully monitored for 24 hours.Spo2 below 90% will be managed with supplemental O2 via nasal cannula or CPAP/NIV according to the condition of the patient. All patients will be encouraged for early mobilization when tolerated and will receive prophylactic LMWH 8–12 h after surgery. 30
Control Group control group regular analgesics throughout surgery and during the postoperative period Patients will be fasting for 8 hours. Induction of anesthesia will be performed by fentanyl 1 mcg/kg, Propofol 2 mg/kg followed by rocuronium bromide 0.6 mg/kg, and after pre-oxygenation with 100% oxygen for at least 3 minutes. Then, patients will be manually ventilated with 100% oxygen till intubation after 2 min and with a BIS value of 50 % by Macintosh laryngoscope and appropriate size endotracheal tube. Maintenance of anesthesia will be carried out by desflurane varying its end-tidal concentration to keep BIS in the range of 50, and rocuronium bromide 0.2 mg/kg guided neuromuscular monitor. Hemodynamics will be maintained within 25 % of baseline measures. All patients will receive IV paracetamol 1 g over 10 min and ondansetron 4 mg approximately 30 min before anticipated extubation time. Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2–3 min will be managed by fentanyl 0.5 mcg/kg. After emergence from anesthesia and immediately in post-anesthesia care unit, analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h) and ketorolac 30mg iv every 12 hrs will be used in all groups. After recovery patients will be transferred to high dependency unit, will be kept in semi-sitting position, and will be fully monitored for 24 hours.Spo2 below 90% will be managed with supplemental O2 via nasal cannula or CPAP/NIV according to the condition of the patient. All patients will be encouraged for early mobilization when tolerated and will receive prophylactic LMWH 8–12 h after surgery. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patient of both sexes aged 20-60 years. 2. Patients are ASA II or ASA III 3. Body mass index (BMI) more than 35 kg/m2 4. Patients scheduled for sleeve gastrectomy. 1) Patient refusal to participate in the study 2) Known allergy to LA. 3) Heart block greater than first degree 4) Renal, cardiac and hepatic dysfunction 5) Underlying coagulopathies 6) Pregnancy or breast feeding Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 08/12/2020 research ethics comittee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
the ring road,kilo 4.5 ,Ismailia,Egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post-operative VAS score at 1, 4, 8, 12 and 24 hours postoperatively.
Secondary Outcome Intraoperative fentanyl consumption during surgery
Secondary Outcome intraoperative desflurane consumption during surgery
Secondary Outcome Intraoperative Heart rate and blood pressure every 5 mins for the first 30 mins post-induction, then every 15 minutes till the end of surgery
Secondary Outcome Postoperative heart rate, Spo2, blood pressure, and respiratory rate at 1, 4, 8, 12 and 24 hours postoperatively.
Secondary Outcome Postoperative 1st request of analgesia after finishing surgery for 24 hours
Secondary Outcome Total morphine consumption during the 1st 24hrs postoperative during the first 24 hours after surgery
Secondary Outcome ERAS outcomes: - Days of hospital stay - PONV - need for postoperative O2 or CPAP/NIV. - Time of removal of urinary catheter after surgery and till discharge from the hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road ,kilo 4.5 ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
suez canal university hospital kilo 4.5,the ring road ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university hospital the ring road ,kilo 4.5 ismailia 41522 Egypt Hospital
Secondary Sponsor anaesthesia departement faculty of medicine suez canal university the ring road ,kilo 4.5 ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
tarek tammam kilo 4,5 ,the ring road ismailia 41522 Egypt
hamdy hendawy kilo 4,5 ,the ring road ismailia 41522 Egypt
wael hassan kilo 4,5 ,the ring road ismailia 41522 Egypt
mohamed elsayed ibrahim ard elgameiat,shikh zayed ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator wael hassan waelhassaan5@yahoo.com +966542214124 the ring road,Kilo 4,5 ,ismailia,egypt
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries tarek tammam tarek1367@hotmail.com +96555554603 the ring road,Kilo 4,5 ,ismailia,egypt
City Postal code Country Position/Affiliation
ismailia 41522 Egypt professor of anesthesia
Role Name Email Phone Street address
Public Enquiries mohamed abdelhamid Mohamed_abuelnga@med.suez.edu.eg +201004150671 ard elgameiat,elsheikh zayed
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries hamdy hendawy hamdyhendawy@gmail.com +201143667734 the ring road,Kilo 4,5 ,ismailia,egypt
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article after deidentification Statistical Analysis Plan,Study Protocol beginning 3 months after publication and ending 12 months following publication to achieve the aims in the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
proposals should be directed to "Mohamed_abuelnga@med.suez.edu.eg "to gain access 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