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.: PACTR202101668845819 Date of Approval: 17/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title erector spinae block and opioid free anethesia in thoracic surgery
Official scientific title Analgesic effect of multimodal anesthetic regimen including erector spinae plane block and opioid free anesthesia in thoracic surgery. A prospective randomized trial.
Brief summary describing the background and objectives of the trial thoracic surgery is associated with severe perioperative pain may lead to serious pulmonary complications , opioids may used to achieve analgesia but it has many side effects like nausea , vomitting , drowsiness and respiratory depression. erector spinae block is an effective safe block may be performed at thoracic and lumbar levels, opioid free anesthesia is multmodal combination of drugs and/or block to acheive good analgesia with avoiding opioids side effects.the aim of this study is to evaluate the analgesic effect of multimodal regimen including erector spinae block and opioid free anethesia in thoracic surgery
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 pain management
Anticipated trial start date 15/01/2021
Actual trial start date
Anticipated date of last follow up 15/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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
Control Group general anesthesia fentanyl 1 µg/kg then propofol 1- 2 mg/kg, followed by atracurium 0.5 mg/kg for tracheal intubation, and maintained with continuous infusion of fentanyl and propofol guided by bispectral index (BIS) between 40 and 60 during surgery After induction suitable size double lumen endotracheal tube will be inserted , patient will be placed in a lateral decubitus position. patient will be mechanically ventilated with an oxygen–air mixture to maintain end‑tidal CO2 between 35 and 40 mmHg monitored by capnogram . Routine intraoperative analgesia will be supplementd in the form of acetaminophen 15mg/kg and ketorolac . At the end of surgery neuromuscular blockade will be reversed using intravenout neostigmine (0.05 mg/kg) and atropine (0.01 mg/kg). Extubation will be done and the patients will be transferred to PACU. for fellow up 30 Placebo
Experimental Group erector spinae plane block and opioid free anesthesia at first erector spinae block performed with 20 mL dose of 0.25% bupivacaine for general anethesia a loading dose of dexmedetomidine 1µg/kg over 10 min, anesthesia will be induced with propofol 1- 2 mg/kg, followed by atracurium 0.5 mg/kg, and will be maintained with continuous infusion of propofol 50 − 200 µg/kg/min and dexmedetomidine 0.3 _0.5 µg/kg/h for maintaining BIS between 40 − 60. Ketamine infusion 0.1- 0.3 mg/kg /hour will be started before incision.(10) Lignocaine 1.5 mg/kg will be administered at induction and an infusion of 2 mg/kg/h will be started immediately after the loading dose the block will be performed before induction of anesthesia, , opioid free drugs with induction and during surgery Ultrasound guided ESPB will be administered before induction of general anesthesia , paients will receive the block in the sitting position under aseptic conditions at the T5 vertebral level using Philip cx 50 extreme edition , USA. 12 MHz linear US probe will be covered with a sterile sheath and will be placed longitudinally 2 to 3 cm lateral to the T5 transverse process. After visualizing erector spinae muscles superficial to the hyperechoic transverse process shadow a 22-gauge 50-mm block needle (B.Braun Medical Inc.,Bethlehem, PA ) will be inserted in a cephalad to caudad direction Once the needle tip placed within the interfacial plane below the erector spinae muscle, 2 mL of saline will be injected to confirm the proper injection site; then, a 20 mL dose of 0.25% bupivacaine will be injected then after induction of general anesthesia suitable size double lumen endotracheal tube will be inserted , patient will be placed in a lateral decubitus position. patient will be mechanically ventilated with an oxygen–air mixture to maintain end‑tidal CO2 between 35 and 40 mmHg monitored by capnogram . At the end of surgery neuromuscular blockade will be reversed using intravenous neostigmine (0.05 mg/kg) and atropine (0.01 mg/kg). Extubation will be done. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 patients of both sexes, American society of anesthesia (ASA) physical state class I–II. aged from 18 to 65years. Scheduled for thoracic surgery 1- patient refusal. 2-preexisting neurological or psychiatric illness. 3- severe hepatic , renal insufficiency and bleeding disorders 4- contraindication or allergy to local anesthetics or study medications 5-unstable cadiorespiratry disorder or any degree of heart bock. 6-chronic use of opioids Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 23/12/2020 research ethics committee
Ethics Committee Address
Street address City Postal code Country
elgeish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total postoperative opioid consumption 24 hours postoperative
Secondary Outcome visual analogue score VAS 1, 2,4,6,12, 24 hours postoperatively
Secondary Outcome respiratory complications postoperative
Secondary Outcome side effects like PONV, local anesthetic toxicity intraoperative and postoperative
Secondary Outcome length of hospital stay and length of ICU stay postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Faculty of Medicine Elgeish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
dr shimaa lrahwan dr laila alahwal dr maram elmazny Elgeish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor dr shimaa elrahwan Elgeish street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
shimaa mostafa elrahwan Elgeish street Tanta 31527 Egypt
laila ahmed elahwal Elgeish street Tanta 31527 Egypt
maram ibrahim elmazny Elgeish street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shimaa Elrahwan shimaarahwan1184@gmail.com +201007186300 Elgeish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries laila Elahwal lailaelahwal@gmail.com +20101848319 Elgeish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Maram Elmazny maramelmazny705@gmail.com +201014137093 Elgeish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of age ,sex, opioid consumption,pain scores and complicatons Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 1 year the IPD will be available for scientific research only up on e-mail request. request will be sent to e-mail of principal investigator (shimaarahwan1184@gmail.com)
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