Title
This is a randomised controlled trail for the patients who need cardiac implantable electronic device (CIED).They are going through with local anaesthesia and sedation with our without pectoral nerve block.
Background
For general, intravenous sedation with local anaesthesia are used for implantation of cardiac implantable electronic devices in daily routine. However, there are still well known side effects of sedation such as peri-procedural hypoxaemia and hypotension. The main aim of using sedation-local anaesthesia is to prevent the drawbacks of general anaesthesia.
This randomised controlled trial is for the patients who are undergoing CIED implantation with local anaesthesia and sedation with or without pectoral nerves block (PECs) to investigate on the result of PECs on sedation usage. PECs block targets the lateral and median pectoral nerves at an interfacial plane between the pectorals major and minor muscles. (Porzionato,2012). This is a novel technique and which aims to block the third to six intercostals, the pectoral, inter costobrachial, and the long thoracic nerves.
The sedation usage is lesser in patient who is receiving PECs block and thus minimise the complications of peri procedural sedation effects. Particularly during the procedure, patients are suffering pain during the skin incision and device pocket creation) and also pain at the incision site after post procedure. It is an ideal combination of PECS block which consists of 0.25% ropivacaine ( long acting local anaesthetic agent) and 1% lignocaine for peri operative pain and that is an adequate long lasting agent that can help to alleviate patient’s pain.
Objectives
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There are two main objectives: primary and secondary objectives.
he primary objectives are assessing preoperative pain scores, total dose of sedation usage, preoperative sedation scores, incidence of hypoxia and hypotension and hypopnea in peri operative period and post anaesthetic discharge score.
The secondary objectives are aim for patient satisfaction scores and procedurist satisfaction scores.
For safety, PECS can reduce the usage of sedation. For efficacy, it could reduce the preoperative pain with minimal or no sedation. Overall, it can improve the satisfaction of cardiologist.
Methodology
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The participants will be from cardiac device clinic or as well as inpatient setting. Aiming for around 120 patients ( 60 patients in each arm) and are recruited from the single institution. There is no restriction in term of gender and ethnicity.
There are three criteria : inclusion criteria, exclusion criteria and withdrawal criteria.
For inclusion criteria, there must have signed of written informed consent and aged between 21-95 years old. The participants have to be fulfilled the criteria for CIED implantation as defined in 2008 guidelines for device-based therapy of cardiac rhythm abnormalities by American College of Cardiology. Ability to communicate with the investigator and to understand and comply of all requirements of study participations.
The exclusion criteria will be pregnant women, who has allergy to local anaesthetic medications and vulnerable subjects such as children, prisoners, mental impairments.
Patient who has found to be allergies later and patients who do not wish to participate can withdraw from the study. Patient who has recent infection or blood stream infection can be withdrawn and reason for withdrawal will be documented.
Methods and assessment
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Control group: The sham block will be given by anaesthetist using ultrasound and aseptic technique. The cardiologist will not be present in the room. 1ml of 1% lignocaine will be used for local infiltration at the needle insertion point.
Intervention group: Anaesthetist will perform the pectoral nerve block by using ultrasound under aseptic procedure. For local infiltration of needle insertion point, 1ml of 1% lignocaine will be used. The US imaged photo will be captured after identification of structures and needle tip placed in position. 0.25% Ropivacaine total 10mls will be injected between pectorals major and minor muscle. The cardiologist will not be present in the room and will be blinded to the solution.Both groups will be monitored vitals and given supplemental oxygen all the time. 15 minutes will be allowed following block, prior to intervention by cardiologist.
Prophylactic antibiotic will be given for all the patients according to policy. 1% lignocaine will be injected initially and also subsequently. IV midazlolam ( 0.5mg ) and fentanyl ( 10-20 mcg) will be injected alone or in combination based on cardiologist. Pain score is assessed by separate assessor. The procedure may be unblinded to determine if further local anaesthesia can be given in the event of severe pain.
Sedation score assessment : Modified Ramsay sedation scoring will be used intra operatively at the same interval as pain score assessment.For safety, sedation will be limited to maximum fentanyl 100mcg and midazlolam 5mg. For underweight patients, dosage will be assessed further if necessary.Sedation will not give if HR < 100 or RR < 8 and modified Ramsay sedation score >4 and give with caution if score is 3.
Modified Ramsey sedation score
1- awake, anxious, agitated and restless
2- awake, cooperative or tranquil
3- awake, responds to commands
4- asleep, brisk response to light, glabella tap, or loud noise
5- asleep, sluggish response to light, glabella tap, or loud noise
6- asleep, no response to light, glabella tap, or loud noise
Pain score assessment : Numeric rating scale (NRS)(Breivik, 2008) will use for pain assessment. 0-no pain
1-3 mild pain
4-6 moderate pain
7-9 severe pain
10 worst pain
Pain assessment will be carried out every 15 minutes ( 0,15,30,45,60 minutes etc) and also at the time of procedure such as pocket creation, Venus access, insertion of CIED. After four hour and eight hour post procedure, post-operative pain score will be monitored.
Operator satisfaction assessment : The intra-operative and post-operative experience of surgeon’s satisfaction assessment will use five-point likert- type scale
1-unacceptable
2-slightly unacceptable
3-neutral
4-slightly acceptable
5-acceptable
Post anaesthetic discharge scoring system will assess evert 15 minutes after procedure ( 0,15,30,45,60 minutes etc)
Depends on patient vital signs, activity, nausea and vomiting, pain and surgical site bleeding )
Randomisation and blinding
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Suitable patients will be randomized in 1:1 by using permuted blocks with different block sizes. The block size and randomisation will be blinded to the investigators.
Ethical consideration
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Informed consent will be taken by the investigators and patients will receive a participant information sheet with procedures detail and purpose, pros and cons of the study.
Centralised Institutional Review Board (CRIB) will review the research study including all documents, study protocol, research information and participants. CRIB needs to approve first the from before the research. The confidential information will be only accessed by the investigators and study team. Even in publication state, the patient identity and information will be remain confidential. All the records of all participants will be retained in secure storage facility and if necessary, records should be accessible for inspection by authorised authorities.
Data analysis
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Data quality assurance and storage
The entered date must be authentic and accurate and there is a random case selection on report for confirmation. The ultrasound image will be easily available and will be reviewed by third party if necessary. (Unlined). The research data will be collected in the password protected PC. Password will be changed periodically and only study team can have access.
Statistical and Analytical plans
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Safety analysis
If rate of infection by device pocket is > 1% and if it is related to PECS procedure, the study will be terminated.
After 30 patients, interim analysis and stopping rule will be performed. If pain score > 7 is 50% or higher, the interim analysis will be performed.
During interim analysis, if the difference is significantly higher in either one of the arms at a significant level of at least P < 0.01, a safety unblinding will be performed and presented to the safety committee. If an early stoppage is triggered and suggest by committee, this study will only be stopped after obtaining approval.