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.: PACTR202008474136439 Date of Approval: 26/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector spinae block for abdominal hysterectomy
Official scientific title Effect of erector spinae plane block on analgesic outcomes in abdominal hysterectomy: A randomized controlled study
Brief summary describing the background and objectives of the trial Good postoperative analgesia can prevent morbidity associated with abdominal hysterectomy by allowing pain-free, early ambulation, and decreasing the risks of long hospital stay, thromboembolism, and other poor outcomes. Regional anesthesia techniques offer good pain relief, reduce perioperative opioid and anesthetic use, reduces postoperative nausea and vomiting, helps in reducing chronic pain, and facilitates early rehabilitation. The erector spinae plane block (ESPB) 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. The injected local anesthetic traverses the costotransverse foramina and blocks ventral rami, dorsal rami of spinal nerves, and rami communicates that gives the sympathetic fibers. We hypothesize that ESPB will be effective for perioperative analgesia in patients undergoing abdominal hysterectomy. our aim is to improve outcomes after abdominal hysterectomy surgeries by adding the newly introduced erector spinae plane block as an adjuvant for general anesthesia.
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 15/09/2020
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 Care giver/Provider,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 25 ml of 0.25% bupivacaine, once intraoperative once intraoperative after induction of anesthesia After fasting for 8 hours, premedications, and pre-oxygenation. 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 3 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 and cis-atracurium 0.03 mg/kg guided neuromuscular monitor. After induction of general anesthesia, the patient will be turned lateral, and the regional anesthetic technique will be commenced. With US-guidance, T10 spinous process will be identified and marked after counting down from the 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 the T10 transverse process, ESM, and trapezius muscle. 10 cm block needle will be introduced in-plane craniocaudally under the vision and navigated till the TP was encountered,25 ml of 0.25% bupivacaine will be injected bilaterally at the same level of T 10 spinous process and drug spread will be seen in the ESP plane craniocaudally in real-time. 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 Control group 25 ml of normal saline,once intraoperative once intraoperative After fasting for 8 hours, premedications and pre-oxygenation. 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 3 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 and cis-atracurium 0.03 mg/kg guided neuromuscular monitor. After induction of general anesthesia, the patient will be turned lateral, and the regional anesthetic technique will be commenced . With US-guidance, T10 spinous process will be identified and marked after counting down from the 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 the T10 transverse process, ESM, and trapezius muscle. 10 cm block needle will be introduced in-plane craniocaudally under the vision and navigated till the TP was encountered,25 ml of normal saline will be injected bilaterally at the same level of T 10 spinous process and drug spread will be seen in the ESP plane craniocaudally in real-time. 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 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patient aged 20-60 years. -Patients are ASA I or ASA II -Patients scheduled for elective abdominal hysterectomy. -Patient refusal to participate in the study -Known allergy to LA. -Body mass index (BMI) more than 35 kg/m2 -Heart block greater than first degree -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) Female
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 13/07/2020 Research ethics committee 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 at the end of 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 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, blood pressure postoperative at 1, 4, 8, 12 and 24 hours.
Secondary Outcome postoperative 1st request of analgesia after finishing surgery for 24 hours
Secondary Outcome postoperative VAS pain score at 1, 4, 8, 12 and 24 hours postoperatively.
Secondary Outcome Postoperative adverse effects: hematoma formation, 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
mohamed elsayed ibrahim ard elgameiat ,elshikh zayed ismailia 41522 Egypt
Ahmed Mohammed AbdElrahman Elewa ard elgameiat ,elshikh zayed ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed eliwa ahmedabdelrahman29@gmail.com +201002744572 ard elgameiat,elsheikh zated
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries ahmed eliwa ahmedabdelrahman29@gmail.com +201002744572 ard elgameiat,elsheikh zated
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific 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
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all participant data collected during the trial Statistical Analysis Plan,Study Protocol immediately following publication to achieve aims of 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