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.: PACTR202008833545332 Date of Approval: 26/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title erector spinae plane block for thyroidectomy
Official scientific title Erector spinae plane block reduces postoperative opioid consumption following total thyroidectomy: A randomized controlled study
Brief summary describing the background and objectives of the trial Thyroid surgery is commonly performed for benign and malignant pathologies of the thyroid gland. Systemic analgesic agents such as non-steroid anti-inflammatory drugs, alpha-2 agonists, pregabalin, and opioids can be used for postoperative pain control. In addition, regional anesthesia can also be used in thyroid surgery, leading to a reduction of systemic analgesic use by alleviating pain. Wound infiltration and cervical plexus block are the main regional methods applied in thyroid surgery. However, the efficacy of bilateral superficial cervical plexus block (BSCPB) in thyroid surgery is controversial. It has been shown that following thyroidectomy; more than 90% of patients require narcotic analgesics during the first 24 postoperative hours. 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. We hypothesize that ESPB and BSCPB will be good analgesic adjuvants to patients undergoing thyroidectomy under general anesthesia. Our aim is to improve outcomes after total thyroidectomy surgery by comparing two techniques of regional anesthesia, the well-established superficial cervical plexus block versus the newly introduced erector spinae plane block.
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 20/09/2020
Actual trial start date
Anticipated date of last follow up 01/05/2021
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
Experimental Group erector spinae plane block ESPB Group 20 ml 0.25% bupivacaine once intraoperative , after induction of anesthesia After Patient fasting for 8 hours, giving premedication, and pre-oxygenation with 100% oxygen for 3 minutes, Induction of anesthesia will be performed by fentanyl 1 mcg/kg, Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg. Then, patients will be manually ventilated with 100% oxygen till intubation after 2 min and with BIS value of 50 %. Maintenance of anesthesia will be carried out by Isoflurane varying its end-tidal concentration to keep BIS in the range of 50 cis-atracurium 0.03 mg/kg guided neuromuscular monitor.US-guided ESPB technique will be performed while the patient is in the lateral position.T2 spinous process will be identified and marked after counting down from C7 spinous process. A linear array high-frequency US probe will be placed in craniocaudal orientation in the midline. The probe will be then moved laterally to identify T2 transverse process, ESM, rhomboidus major, and trapezius muscle. 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 was done to confirm separation of ESM from TP. Under real-time US guidance, 20 ml 0.25% bupivacaine will be injected in each side in the ESP plane. Hemodynamics will be maintained within 25 % of baseline measures. 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. Upon completion of wound closure, isoflurane will be discontinued and the residual neuromuscular block will be reversed. After emergence from anesthesia and immediately in the post-anesthesia care unit, 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 for 24 hours. 30
Control Group superficial cervical plexus block SCPB group 10 ml of 0.25% bupivacaine once intraoperative after induction of anesthesia After Patient fasting for 8 hours, giving premedication, and pre-oxygenation with 100% oxygen for 3 minutes, Induction of anesthesia will be performed by fentanyl 1 mcg/kg, Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg. Then, patients will be manually ventilated with 100% oxygen till intubation after 2 min and with a BIS value of 50 %. Maintenance of anesthesia will be carried out by Isoflurane varying its end-tidal concentration to keep BIS in the range of 50 cis-atracurium 0.03 mg/kg guided neuromuscular monitor. Superficial cervical plexus block will be done while the patient is in the supine position. A linear array high-frequency US probe will be placed transversely on the posterior border of the sternocleidomastoid (SCM) muscle at the level of C4, to identify the SCM muscle, carotid artery, and internal jugular vein. The superficial cervical plexus will be visualized as a hypoechoic structure at the posterior corner of the SCM muscle. The needle will be inserted under the SCM muscle with the in-plane technique. After negative aspiration of blood and air, the needle position and localization were confirmed by injecting 0.5–1 ml of solution. Then, 10 ml of 0.25% bupivacaine will be injected on each side. Hemodynamics will be maintained within 25 % of baseline measures. 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. Upon completion of wound closure, isoflurane will be discontinued and the residual neuromuscular block will be reversed. 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 for 24 hours. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patient aged 20-60 years from both sexes. -Patients are ASA I or ASA II . -Patients scheduled for total thyroidectomy. -Patient refusal to participate in the study -Known allergy to LA. -Body mass index (BMI) more than 35 kg/m2Heart block greater than first degree -Chronic pulmonary disorders like COPD -Cardiac,Renal, and hepatic dysfunction -Underlying coagulopathies 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 29/06/2020 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 total morphine consumption at the end of 24 h postoperatively after finishing surgery for 24 hours
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 Total intraoperative fentanyl consumption. at the end of surgery
Secondary Outcome Total intraoperative isoflurane consumption. at the end of surgery
Secondary Outcome Postoperative heart rate and blood pressure postoperative at 1, 4, 8, 12 and 24 hours.
Secondary Outcome Postoperative 1st request of analgesia postoperative for 24 hours
Secondary Outcome postoperative VAS pain scores at 1, 4, 8, 12 and 24 hours postoperatively.
Secondary Outcome Postoperative complications like respiratory depression, hematoma, nausea and vomiting after finishing surgery for 24 hours
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 the ring road,Kilo 4.5 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 University
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
Ahmed Mohammed AbdElrahman Elewa ard elgameiat ,elshikh zayed ismailia 41522 Egypt
mohamed elsayed ibrahim ard elgameiat ,elshikh zayed ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator 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
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 ahmed eliwa ahmedabdelrahman29@gmail.com +201002744572 ard elgameiat,elsheikh zayed
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 Statistical Analysis Plan,Study Protocol immediately following publication to achieve aims in the approved proposal
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