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.: PACTR201812544261175 Date of Approval: 06/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of Ultrasound Guided Thoracic Erector Spinae Plane Block, Thoracic Paravertebral and Thoracic Epidural for Pain Management after Nephrectomy
Official scientific title Comparison of Ultrasound Guided Thoracic Erector Spinae Plane Block, Thoracic Paravertebral and Thoracic Epidural for Pain Management after Nephrectomy
Brief summary describing the background and objectives of the trial Many regional blocks are well described for post nephrectomy pain managment with different complications for each block such as paravertebral block, epidural block, recently erector spinae block so our aim is to evaluate the efficacy of ultrasound guided erector spinae block as a safe alternative to ultrasound guided thoracic paravertebral and thoracic epidural for pain management after nephrectomy surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/12/2018
Actual trial start date
Anticipated date of last follow up 10/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
Recruitment status Completed
Publication URL DOI: 10.9734/jammr/2022/v34i1931437
Secondary Ids Issuing authority/Trial register
32575 Tanta University Quality Assurance Center
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 ultrasound guided erector spinae block 20 ml plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the eighth thoracic segment (T8) once before surgery. one shot injection The patient will be placed in a sitting position and superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation, 3 cm lateral to the T8 spinous process. An 8-cm 22-gauge spinal needle will be inserted in cephalic direction until the needle tip hit the transverse process of T8 under ultrasound image visualization, then the needle will be withdrawn slowly to be within the interfacial plane below the erector spinae muscle, then the anesthetic mixture will be injected . 35
Experimental Group US guided Thoracic Paravertebral Block 20ml) (plain bupivacaine 0.25% injected in the paravertebral space) at (T8). single shot before surgery Patients of the PVB group will be placed sitting upright with the neck and back flexed and the shoulders relaxed forward. The spinous process of T8 will be palpated and marked at its inferior aspect. After sterilization of the back of the patient with Povidone iodine 10%, 3 ml Lignocaine will be injected subcutaneously 3 centimeters lateral to the spinous process of T8 making awheel, a 2-5 MHz low frequency transducer will be placed parallel to the spinous process. The transverse process (TP), the costo-transverse ligament (CTL) and the pleura (P) will be identified. Tilting of the probe may allow for better visualization of the costo-transverse ligament and pleura. Spinal 22G needle (B. Braun, Melsungen, Germany) will be inserted at the cephalic end of the transducer using in-plane technique, the needle is directed towards the CTL. The passage of the needle through the CTL is associated with a pop; indicating that the needle crossed the superior costotransverse ligament. After gentle aspiration of the syringe for exclusion of blood and air, anesthetic mixture will be injected into the paravertebral space. 35
Control Group Thoracic Epidural Block (20ml) (plain bupivacaine 0.25% injected in the Epidural space) at (T8). single shot injection before starting surgery The T8–T9 intervertebral level will be identified by counting-up from the last rib. The puncture will be performed via paramedian approach; the probe will be placed in longitudinal direction at the level of the 12th rib in a parasagittal plane 2 cm from the midline. Then moving the probe upward and the ribs will be counted until reaching the 8 th rib. Then the probe will be directed medially to identify the dura matter at the T8–T9 intervertebral space, and a skin mark will be placed to identify the correct level of the block. The block will be performed after sterilization of the back. The puncture will be performed via paramedian approach in all patients with a 18 G needle (B. Braun, Melsungen, Germany) using loss of resistance technique. After gentle aspiration of the syringe for exclusion of blood and air, anesthetic mixture will be injected into the epidural space. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of both sex ASA physical activity I, II aged 18 years or older admitted for elective nephrectomy surgery  Patient refusal.  Patient with neurological deficit.  Patient with bleeding disorders.  Uncooperative patient.  Infection at the block injection site.  Patients with history of allergy to local anesthetics. 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) 79 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 30/09/2018 Tanta University Quality Assurance Center
Ethics Committee Address
Street address City Postal code Country
Elgeish st Tanta 31111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  Total opioid consumption in the first day after surgery. 2,4,6,12,18,24h after surgery
Secondary Outcome  Time to first rescue analgesic demand after surgery 2, 4, 6, 12, 18, 24 h
Secondary Outcome  Visual Analogue score (VAS). 2, 4, 6, 12, 18, 24 h
Secondary Outcome  Complications occurrence (hypotension, pneumothorax, Local Anesthetic Systemic Toxicity (LAST), Failure). T0
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital El- Geish st, Tanta 31111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
anesthesia department tanta university hospital el geish st tanta 31111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta university elgeish st Tanta 31111 Egypt University
Secondary Sponsor Anesthesia department Tanta university hospitals el geish st Tanta 31111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Thanaa Mohammed Elnoamany elnady st, Tanta 31111 Egypt
Hesham Mohammed Marof othman mohamed st tanta 31111 Egypt
Amera Mahfouz Abdelsamad omar ebn abdelaziz tanta 31111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saad Moharam saad2hmed@gmail.com +201090663262 reyad ghoraba
City Postal code Country Position/Affiliation
tanta 31111 Egypt assisstant lecturer
Role Name Email Phone Street address
Scientific Enquiries thanaa elnoamany mohamed.ayad@med.tanta.edu.eg +20104968967 Omar-ebnabdelaziz st
City Postal code Country Position/Affiliation
Tanta 31111 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries hesham maarof heshammarouf@med.tanta.edu.eg +20123144809 othman mohamed st
City Postal code Country Position/Affiliation
tanta 31111 Egypt professorof anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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