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.: PACTR202401792514810 Date of Registration: 24/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound Guided Pectoralis Nerve Block as a Novel Approach in Pacemaker Implantation
Official scientific title Ultrasound Guided Pectoralis Nerve Block as a Novel Approach in Pacemaker Implantation: A randomized clinical trial
Brief summary describing the background and objectives of the trial The use of implantable cardiac electronic devices, including pacemakers, for the treatment of cardiac arrhythmias is increasing worldwide. The relative ease of device implantation using a relatively simple, rapid, percutaneous approach without the need for general anesthesia or long recovery times has driven interest in implantation. Analgesia and sedation are typically a challenge during pacemaker implantation. Patients may experience severe pain during and after the procedure. Excessive administration of local anesthetics may result in inadequate wound healing and systemic toxicity. Regional anesthesia is associated with less perioperative morbidity and mortality than general anesthesia. Regional anesthesia of the thoracic wall can be achieved with various techniques including epidural, paravertebral, intercostal and PECS blocks. The advent of ultrasound has led to the development of various interfacial plane blocks for better pain management in thoracic and abdominal wall surgery. Ultrasound has increased the success rate of these blocks and decreased local anesthetic dosage requirements compared to the traditional landmark technique. The purpose of this study was to evaluate the efficacy and safety of pectoral nerve blocks (PECS) I and II as the primary anesthetic technique in patients undergoing subcutaneous pacemaker implantation compared to local infiltration anesthesia.
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 01/02/2022
Actual trial start date 01/02/2022
Anticipated date of last follow up 31/08/2022
Actual Last follow-up date 31/08/2022
Anticipated target sample size (number of participants) 40
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Pacemaker implantation under local infiltration anesthesia Just before the procedure After placement of standard American Society of Anesthesiologists ‘ASA’ monitors, sedation for the procedure was provided by a dexmedetomidine infusion at 0.3 -0.7 ug/kg/min. Then, the patients received standard local infiltration anesthesia with lidocaine 2% (10-15 ml) 20 Active-Treatment of Control Group
Experimental Group Pacemaker implantation under PECS blocks Just before the procedure After placement of standard American Society of Anesthesiologists ‘ASA’ monitors, sedation for the procedure was provided by a dexmedetomidine infusion at 0.3 -0.7 ug/kg/min. After skin infiltration with lidocaine and under ultrasound guidance, a dose of 0.2 ml/kg of bupivacaine 0.25% was injected between the pectoralis muscles (PECS I), and a similar dose was injected between the pectoralis minor and the serratus anterior muscle at the level of the fourth rib (PECS II). 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age between 21 and 80 year undergoing subcutaneous pacemaker implantation patient refusal inability to understand and sign consent infection at the injection site known allergy to local anesthetics coagulopathy (INR >1.5) history of stroke with residual hemiplegia at site of injection Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 80 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 17/11/2021 Research Ethics Committee of the Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total morphine doses required by the patient intraoperatively at the end of the procedure
Primary Outcome Visual Analog scale (VAS) At 0, 6, 12, and 24 h postoperatively
Secondary Outcome Operator satisfaction After the procedure
Secondary Outcome Patient satisfaction After the prodedure
Secondary Outcome Time of first analgesic request Every 0.5 h postoperatively
Secondary Outcome Complications e.g. apnea Intraoperative and postoperative assessment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aswan heart center Kasr El Hagar St. Aswan Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dalia Ibrahim 38 Abbassia Square, Next to Al-Nour Mosque Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals 38 Abbassia Square, Next to Al-Nour Mosque Cairo Egypt Hospital
Secondary Sponsor Aswan heart center Kasr El Hagar St. Aswan Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalia Ibrahim dalia.ibrahim@mail.com +201005307867 38 Abbassia Square, Next to Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Dalia Ibrahim dalia.ibrahim@mail.com +201005307867 38 Abbassia Square, Next to Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Sara Amin sara.m.amin@mail.com 0000000000000 38 Abbassia Square, Next to Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the de-identified individual participants data. All datasets generated and/or analyzed during the current study will be available from the corresponding author on reasonable request. This will begin 12 months and end 24 months following publication of the manuscript. Study Protocol Starting 12 months and ending 24 months following publication of the manuscript Data will be available through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 18/01/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 18/01/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information