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.: PACTR202203766891354 Date of Approval: 16/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rhomboid intercostal block versus serratus block for postoperative analgesia after thoracoscopic sympathectomy.
Official scientific title Rhomboid intercostal block versus serratus block for postoperative analgesia after thoracoscopic sympathectomy for primary palmar hyperhidrosis.
Brief summary describing the background and objectives of the trial Primary hyperhidrosis is a disorder characterized by excessive and chronic sweating in the absence of a sweating trigger. The disorder can be severe and interfere with the normal daily activities of the patients. Resectional surgery of sympathetic nerves has been known to be the most effective treatment for essential hyperhidrosis. With recent advances in video-assisted thoracoscopic surgery, upper thoracic dorsal sympathectomy has emerged as a first-line treatment for essential hyperhidrosis. Postoperative pain is more severe than is generally recognized. Most patients report quite sharp pain, especially on deep inspiration, for a few hours post-operatively. Pain after thoracic surgery not only causes a strong stress reaction and adverse emotional experience but also affects postoperative rehabilitation. The analgesic effects of local anesthetic infiltration and intercostal nerve block are short and poor. Paraspinal block and thoracic epidural anesthesia may cause parasympathetic symptoms, resulting in hypotension, bradycardia, and even syncope The purpose of this study is to compare rhomboid intercostal block versus serratus block regarding pain control in patients undergoing thoracoscopic sympathectomy for palmar hyperhidrosis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/03/2022
Actual trial start date
Anticipated date of last follow up 20/02/2023
Actual Last follow-up date 01/03/2023
Anticipated target sample size (number of participants) 213
Actual target sample size (number of participants)
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no intervention till the end of the surgery • All patients in this group will not receive serratus block or rhomboid block. 71 Placebo
Experimental Group Rhomboid intercostal block before skin incision after initiation of general anesthesia • All patients in this group will receive 20-mL 0.25% bupivacaine to perform the rhomboid intercostal block. 71
Experimental Group Serratus block before skin incision after initiation of general anesthesia • All patients in this group will receive 20-mL 0.25% bupivacaine to perform serratus block. 71
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- American Society of Anesthesiologists (ASA) physical status grades I and II. 2. Patients with severe hyperhidrosis. 3-Both sex 1. Age beyond the previous limits. 2. ASA class > II. 3. Bleeding diathesis. 4. Previous thoracic surgery. 5. Skin infection at the site of injection. 6. Cardiovascular & respiratory diseases. 7. The presence of psychiatric illness. 8. History of opioid abuse. 9. Known allergy to the study medications. Adult: 19 Year-44 Year 15 Year(s) 40 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 31/10/2021 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
Institutional Review Board- IRB- office building A- ground floor- faculty of medicine-Mansoura University. Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The primary outcome will be the Post-operative pain and the time of the First analgesic request. VAS score will be assessed immediately after the procedures, 1h, 3h, 6h, 12h, and 24h postoperatively. The time to first analgesic request will be recorded immediately postoperative.
Secondary Outcome 1- the amount of postoperative analgesic requirement Total amount of post-operative analgesics will be recorded. over 24h.
Secondary Outcome 2- Hemodynamic changes between the two groups at the baseline, and then every 10 min till the end of the procedure
Secondary Outcome 3- Patient satisfaction post-operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospitals Elgomhouria St., Mansoura City, Egypt Mansoura City Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Gad Elhouty El Gomhouria St, Dakahlia Governorate Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Elgomhouria St., Mansoura City, Egypt Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elhouty dr_mohamedgad2000@yahoo.com 01093019320 Elgomhouria St., Mansoura City, Egypt
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mostafa Elawady sasaelawady@gmail.com 01004062862 Elgomhouria St., Mansoura City, Egypt
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Mohamed Elhouty dr_mohamedgad2000@yahoo.com 01093019320 Elgomhouria St., Mansoura City, Egypt
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate data and share it through the PubMed indexed journal
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