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.: PACTR201707002380245 Date of Approval: 27/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Erector Spinae Plane Block for thoracotomy
Official scientific title Ultrasound guided Erector Spinae Plane Block for postoperative analgesia after thoracotomy; a prospective randomized controlled study
Brief summary describing the background and objectives of the trial Open thoracotomy is one of the most painful surgical procedures and post-thoracotomy pain markedly affects postoperative respiratory function and patient recovery 1,2. Post-thoracotomy pain belongs to incision, damage of ribs and intercostal nerves, chest wall inflammation, cut of pleura and pulmonary parenchyma and placement of thoracotomy drainage tube 3. A variety of analgesic techniques like systemic opioid, intercostal nerve blockade, intrapleural analgesia, epidural opioid with or without local analgesic, cryoanalgesia, paravertebral nerve blockage, Transcutaneous electrical nerve stimulation (TENS) are used for post-thoracotomy pain management 3. Besides these techniques, patient controlled analgesia (PCA) via systemic or epidural route has been used very commonly 1. The ultrasound-guided erector spinae plane (ESP) block is a recently described regional anesthetic technique for providing thoracic analgesia when performed at the level of the T5 transverse process. Local anesthetic injected into the fascial plane deep to the erector spinae muscle spreads in a craniocaudal fashion over several levels. Local anesthetic also penetrates anteriorly through the intertransverse connective tissue and enters the thoracic paravertebral space where it can potentially block not only the ventral and dorsal rami of spinal nerves but also the rami communicantes that transmit sympathetic fibers 4,5. The aim of the current study is to evaluate the effects of ultrasound guided erector spinae plane block on postoperative analgesia in patients undergoing open thoracotomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2017
Actual trial start date 14/06/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
31512/04/17 Tanta University, Faculty of Medicine,Research Ethics Committee, Quality Assurance Unit
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 permuted block randomisation 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
Control Group Control group ( C ) sham ESPB using 20 ml normal saline once sham ESPB. 30 Placebo
Experimental Group Erector Spinae Plane Block group ( ESPB ) 20 ml solution comprising of 5 mL 2% lidocaine and 5ml 0.5% bupivacaine and 10 ml normal saline once Erector Spinae Plane Block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 18 ¿ 60 years, of either gender, ASA I-II, undergoing elective open thoracotomy patient refusal, allergy to the study drugs, morbid obesity, pregnancy, patients under pain control for the last 24 hours, patients unable to use PCA (Patient Controlled Analgesia) patients with neuropathies 18 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 01/04/2017 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish street Tanta 31951 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction in VAS score immediately after transport to PACU, 1h, 2h, 4h, 6h, 8h, 12h and 24h.
Secondary Outcome total postoperative morphine consumption 24 h postoperative
Secondary Outcome intraoperative fentanyl consumption. at the end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU 10 Algeish street Tanta 31951 Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra 31951 Egypt
Mohamed Mohye Eldin 55 Stad street Tanta 31951 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra 31951 Egypt Lecturer ofanesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta 31951 Egypt Lecturer ofanesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta 31951 Egypt Lecturer ofanesthesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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