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.: PACTR202008534389448 Date of Approval: 03/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Rhomboid Intercostal and Subserratus Plane Block (RISS) for perioperative analgesia in patients undergoing thoracotomy; a prospective randomized controlled study
Official scientific title Rhomboid Intercostal and Subserratus Plane Block (RISS) for perioperative analgesia in patients undergoing 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. Interfacial plane blocks of the chest wall remain in early stages of development, but initial results show promise in offering alternatives to neuroaxial blocks.4,5 Chest wall blocks represent an umbrella term wherein a number of successful approaches have been described. The serratus anterior plane block 6,7 has been used for analgesia after breast surgery,8–11 postmastectomy pain,12,13 thoracoscopic surgery,14,15 pain associated with rib fractures, shoulder surgery,16–19 open thoracotomy,20 and postthoracotomy pain.21–23 The erector spinae plane block 24 has been used for acute postsurgical pain, posttraumatic pain 24,25 and chronic neuropathic pain conditions.24 Rhomboid intercostal and subserratus plane (RISS) block demonstrates the concept of continuity between chest wall fascial planes with consistent spread of injectate to the lateral cutaneous branches of the T4 to T9 intercostal nerves in cadavers and consistent analgesia from the T5 to T8 dermatomes in a clinical case series. 25 The aim of the current study is to evaluate the effects of ultrasound guided RISS block on perioperative 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 perioperative analgesia in patients undergoing open thoracotomy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2019
Actual trial start date 16/10/2020
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date 05/11/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
33044 Tanta University Faculty of Medicine Research Ethics Committee
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
Control Group control group general anesthesia only general anesthesia only during whole surgical procedure general anesthesia only 30 Placebo
Experimental Group Rhomboid intercostal and subserratus plane block a rhomboid intercostal injection using 10 ml bupivacaine 0.25% and a subserratus plane injection using 20 ml bupivacaine 0.25% with 1:200 000 epinephrine. single shot Rhomboid intercostal and subserratus plane block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18 – 60 years either gender ASA I-III undergoing elective open thoracotomy patient refusal allergy to the study drug body mass index (BMI) > 35 kg/m2 any contraindication to regional anesthesia e.g. coagulopathy pregnancy drug or alcohol abuse daily intake of opioid analgesics Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 01/04/2019 Tanta University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Algeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS score during the first 24 h postoperatively immediately after transport to PACU, 30 min,1h,2h,4h,6h,8h,12h, 18 h and 24h
Secondary Outcome intraoperative fentanyl consumption. after the end of surgery
Secondary Outcome the first 24 h postoperative cumulative morphine consumption at 24 h postoperatively
Secondary Outcome the time to first morphine dose when occurs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University Algeish street Tanta Egypt University
Secondary Sponsor Department of anesthesia and surgical ICU Tanta University Hospital Algeish street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohye Eldin 55 Stad street Tanta Egypt
Shaimaa Farouk 1 Moheb street Almahalla Alkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mohye Eldin mohd_yazed75@yahoo.com 01099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anesthesia and surgical ICU Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Shaimaa Farouk shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra Egypt lecturer of anesthesia and surgical ICU Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin mohd_yazed75@yahoo.com 01099707168 55 Stad street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anesthesia and surgical ICU Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data of the primary outcome Informed Consent Form data will be available for 6 months after the manuscript is accepted for publication data will be accessed through the corresponding author within the specified time frame.
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