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.: PACTR201709002512418 Date of Approval: 10/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pain relief after thoracoscopy
Official scientific title Ultrasound guided serratus plane block versus erector spinae block for postoperative analgesia in video assisted thoracoscopy
Brief summary describing the background and objectives of the trial The control of postoperative pain in patients after intra- thoracic surgery is critical to the rehabilitation of their respira- tory function. Postoperative pain in the chest wall can cause splinting which will impair couching, deep breathing leading to retention of secretions and a decrease in FRC. These problems have been shown to be a source of great morbidity and should be managed aggressively. The options for postoperative pain management should begin preoperatively and not postopera- tively. Pain control options include: Cognitive/behavioral (i.e., relaxation, distraction and imagery techniques), Intravenous administra- tion of opioids and adjuvant agents (i.e., nonsteroidal antiin- flammatory drugs, tri-cyclic agents) on an ¿around the clock¿ and or PRN basis, PCA intravenous pumps, neuraxial (epidural, intrathecal) agents (local anesthetics, opioids, ketamine, cloni- dine, alpha agonists), intermittent neural blockade (with local anesthetics, cryoprobe, neurolytic agents ) or continuous neural blockade (with an intrapleural catheter), physical application of hot and cold compresses or TENS (transcutaneous electrical nerve stimulation). In the past few years video-assisted thoracoscopic surgery (VATS) has been used increasingly. Although it is considered a less invasive treatment than thoracotomy, patients can experience moderate to severe pain, especially during the first hours after surgery. The aim of this study is to compare the perioperative analgesic effect of ultrasound guided erector spinae block (ESB) and ultrasound guided serratus plane block (SPB) in patients undergoing video assisted thoracoscopy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied post thorcoscopy pain management,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 03/09/2017
Actual trial start date 10/09/2017
Anticipated date of last follow up 08/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group A 20 ml of 0.25% bupivacaine after induction of general anesthesia once single shot ultrasound guided erector spinae block 30
Experimental Group group B 20 ml of 0.25% bupivacaine after induction of general anesthesia once single shot ultrasound guided serratus plane block 30
Experimental Group group A 20 ml of 0.25% bupivacaine after induction of general anesthesia once single shot ultrasound guided erector spinae block 30
Experimental Group group B 20 ml of 0.25% bupivacaine after induction of general anesthesia once single shot ultrasound guided serratus plane block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I or II scheduled for elective unilateral thoracoscopy Patients with severe respiratory disease, preexisting neurologic deficit¿ allergy or contraindication to the use of bupivacaine, pethidine or paracetamol or to any of the study drugs, presence of local infection, on current chronic analgesic therapy, having history of opioid dependence¿ patient refusal or inablity to communicate with the investigators. patients who will require postoperative mechanical ventilation 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 27/07/2017 faculty of medicine, menoufia university
Ethics Committee Address
Street address City Postal code Country
25 yasin abdelghafar street shibin elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score using VAS both at rest (static) and during cough (dynamic) as soon as the patient becomes alert enough to report pain, at PACU admission¿ every 1hour for the first 8hours¿ every 3hours for the remaining time till completing 24 hours
Primary Outcome ¿ Time for first request of analgesic requirement once postoperatively
Primary Outcome The total 24 hours analgesic consumption will be recorded (opioid and non opioid) for every patient. at the end of the 24 hours after the block
Primary Outcome intraoperative fentanyl requirements at the end of surgery
Secondary Outcome hemodynamics : HR, MAP baseline before induction of anestheisa After induction of general anesthesia every 5 minutes all through the surgery at PACU admission ¿ after 2 hours then after 6¿12and 24 hours.
Secondary Outcome arterial blood gases at PACU admission ¿ after 2 hours after 6¿12and 24 hours
Secondary Outcome respiratory rate at PACU admission ¿ after 2 hours after 6¿12and 24 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university hospitals 25 yasin abdelghafar street shibin elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine, menoufia university 25 yasin abdelghafar street shibin elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine, menoufia university 25 yasin abdelghafar street shibin elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
khaled gaballah 25 yasin abdelghafar street shibin elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in anaesthesia and intensive care medicine
Role Name Email Phone Street address
Public Enquiries nadia bahgat dr_nmbahgat@yahoo.com 00201222850598 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Scientific Enquiries nadia bahgat dr_nmbahgat@yahoo.com 00201222850598 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
REPORTING
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