Analgesia After Coronary Artery Bypass Graft SurgeryPhase 3NCT05691920
Regional Blocks for CABG Artery Bypass Graft Surgery
A Phase 3 study testing Pectointercostal plane block and external oblique intercostal plane block and Fentanyl infusion in people with Analgesia After Coronary Artery Bypass Graft Surgery, run by Alexandria University.
Trial summary
Pain control after CABG is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks. Regional blocks allow better pain control and avoid side effects of opioid based pain control Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Analgesia After Coronary Artery Bypass Graft Surgery
- What is being tested?
- Pectointercostal plane block and external oblique intercostal plane block and Fentanyl infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing CABG surgery
Who cannot join
- BMI above 40
- allergy for drugs used
- complicated cases
- patient refusal
- chronic opioid use
- cognitive dysfunction
- chronic kidney disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided External Oblique Intercostal Plane Block and Pectointercostal Plane Block for Perioperative Analgesia in Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study
Pain control after CABG is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.
Regional blocks allow better pain control and avoid side effects of opioid based pain control
Read the detailed description
Ultrasound guided External oblique intercostal plane block and pectointercostal plane block for perioperative analgesia in coronary artery bypass graft surgery: Prospective randomized controlled study
Introduction:
Pain control is a vital component to achieve enhanced recovery after cardiac surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.
Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Enhanced recovery following coronary artery bypass grafting (CABG) has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.
The external oblique intercostal plane and pectointercostal plane blocks are a new modality that will be used to improve pain-related outcomes after CABG surgery, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane and pectointercostal plane blocks can reduce cumulative opioid consumption for the patients undergoing CABG surgery when added to conventional multi-model intravenous analgesic technique.
The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane and pectointercostal plane blocks in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing CABG surgery.
Patients and Methods:
A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 40-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks and group II (60) will be subjected to fentanyl infusion at a rate of 1μg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.
- Being tested
- Pectointercostal plane block and external oblique intercostal plane block, Fentanyl infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectointercostal plane block and external oblique intercostal plane blockProcedure or surgery
Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks
Fentanyl infusionProcedure or surgery
Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Block group | Active comparator | Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks Receives: Procedure: Pectointercostal plane block and external oblique intercostal plane block |
| Opioid group | Active comparator | Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h Receives: Procedure: Fentanyl infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative fentanyl requirements for 24 hours
Visual analogue score will be measured every 2 hours
Measured: 24 hours postoperatively
Secondary outcomes (3)
Visual analogue score
Visual analogue score will be measured every 2 hours
Measured: 24 hours postoperatively
Rescue analgesia
0.5 microgram/kg fentanyl will be given if visual analogue score more than 4
Measured: 24 hours postoperatively
Side effects
Any side effect related to fentanyl or block technique will be detected and treated properly
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia After Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691920
- Sponsor's protocol ID
- 0305397
- Status last verified
- Nov 2022
- First submitted
- 11 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on request
Publications
Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
PubMed 31054241
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided External Oblique Intercostal Plane Block and Pectointercostal Plane Block for Perioperative Analgesia in Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05691920
- Acronym / sponsor ID
- 0305397
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain control after CABG is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.
Regional blocks allow better pain control and avoid side effects of opioid based pain control
Detailed description
Ultrasound guided External oblique intercostal plane block and pectointercostal plane block for perioperative analgesia in coronary artery bypass graft surgery: Prospective randomized controlled study
Introduction:
Pain control is a vital component to achieve enhanced recovery after cardiac surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.
Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Enhanced recovery following coronary artery bypass grafting (CABG) has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.
The external oblique intercostal plane and pectointercostal plane blocks are a new modality that will be used to improve pain-related outcomes after CABG surgery, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane and pectointercostal plane blocks can reduce cumulative opioid consumption for the patients undergoing CABG surgery when added to conventional multi-model intravenous analgesic technique.
The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane and pectointercostal plane blocks in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing CABG surgery.
Patients and Methods:
A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 40-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks and group II (60) will be subjected to fentanyl infusion at a rate of 1μg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block group | Active comparator | Procedure: Pectointercostal plane block and external oblique intercostal plane blockPatients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks |
| Opioid group | Active comparator | Procedure: Fentanyl infusionPatients will be subjected to fentanyl infusion at a rate of 1μg/kg/h |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing CABG surgery
Key exclusion criteria (7 listed)
- BMI above 40
- allergy for drugs used
- complicated cases
- patient refusal
- chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pectointercostal plane block and external oblique intercostal plane blockPatients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks | Procedure or surgery | Block group |
| Fentanyl infusionPatients will be subjected to fentanyl infusion at a rate of 1μg/kg/h | Procedure or surgery | Opioid group |
Primary outcome
Postoperative fentanyl requirements for 24 hours
Time frame: 24 hours postoperatively
Visual analogue score will be measured every 2 hours
3 secondary outcomes
Visual analogue score
Time frame: 24 hours postoperatively
Rescue analgesia
Time frame: 24 hours postoperatively
Side effects
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 31054241Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
- Individual participant dataSharing planned: Yes. Data will be shared on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pectointercostal plane block and external oblique intercostal plane block and Fentanyl infusion in people with Analgesia After Coronary Artery Bypass Graft Surgery, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdelmawla, MD (+201114748411, M_abdelmawla12@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative fentanyl requirements for 24 hours (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05691920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.