Postoperative PainNCT05774249
Pecto-intercostal Fascial Plane Block for Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery
A study testing Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine and Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Moderate to severe postoperative pain is usually encountered after cardiac surgery.Improper postoperative pain control could have multiple hemodynamic hazards in addition to prolonged postoperative ventilatory support and intensive care unit stay .The safety and efficacy of ultrasound guided chest wall plane blocks… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine and Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 20 Jul 2023
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA ( New york heart association ) class I- III
Who cannot join
- Parents' refusal to study participation.
- Patients with poor coronary vessels targets.
- Patients with poor cardiac systolic function or preoperative hemodynamic unstability
- Redo coronary artery bypass surgery
- Intraoperative complication need conversion to on pump surgery
- Postoperative exploration for bleeding or poor coronary revascularization
Show all 9Show fewer
- Advanced COPD(chronic obstructive pulmonary disease) patients.
- Myopathies and myasthenic patients
- Allergy to study medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Adding Pecto-intercostal Fascial Plane Block on the Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery
Moderate to severe postoperative pain is usually encountered after cardiac surgery.Improper postoperative pain control could have multiple hemodynamic hazards in addition to prolonged postoperative ventilatory support and intensive care unit stay .The safety and efficacy of ultrasound guided chest wall plane blocks has been described for postoperative analgesia after cardiac surgeries.
Study objective: to investigate the effect of adding of pecto-intercostal fascial plane block on the postoperative pain control, perioperative analgesic consumptions and the time for ventilation weaning and intensive care unit discharge in patients who will undergo off-pump Coronary artery bypass surgeries.
Methods: This study patients will be randomly assigned to 2 Groups to receive preoperative ultrasound-guided pecto-intercostal fascial plane block with either 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 or saline bilaterally.
Read the detailed description
After preoperative patients' anesthesia assessment; the study patients (20 in each group) will receive general anesthesia under invasive monitoring of hemodynamics, and oxygen saturation. After anesthesia induction; cannulation of jugular vein and insertion of transoesophageal echocardiography and temperature probe will be done. In block group : while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally. In control group:Sham Block will be done using 20 mL of normal saline 0.9% bilaterally .
Anesthesia will be maintained with sevoflurane inhalational anesthesia and incremental cisatracurium and fentanyl for intraoperative muscle relaxation and analgesia respectively. Intraoperative anticoagulation will be carried out before revascularization using intravenous heparin titrated according to activated clotting time ,which will be reversed after end of surgery using protamine sulfate.
At the end of surgery patients will be sent to post cardiac surgery intensive care unit . Postoperative analgesia in the form of intravenous paracetamol one gram will be administered on intensive care unit admission then fentanyl based patient controlled analgesia will be started . IV tramadol 1mg/kg as second rescue analgesia will be given if visual analogue scores are still ≥ 4.
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine, Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaineProcedure or surgery
while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally.
Ultrasound guided pecto-intercostal Fascial Plane Block using normal salineProcedure or surgery
Sham Block will be done while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of normal saline 0.9 % will be administered bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided pectointercostal fascial plane block group | Active comparator | using 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 Receives: Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine |
| control group | Placebo comparator | using 20 mL of normal saline 0.9% Receives: Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score
0 (no pain) and 10 (worst possible pain)
Measured: immediately after extubation
visual analogue score
0 (no pain) and 100 (worst possible pain)
Measured: 1 st hour after extubation
visual analogue score
0 (no pain) and 100 (worst possible pain)
Measured: 2 nd hour after extubation
visual analogue score
0 (no pain) and 100 (worst possible pain)
Measured: 4 th hour after extubation
visual analogue score
0 (no pain) and 100 (worst possible pain)
Measured: 8 th hour after extubation
visual analogue score
0 (no pain) and 100 (worst possible pain)
Measured: 12 th hour after extubation
visual analogue score
0 (no pain) and 100 (worst possible pain)
Measured: 18 th hour after extubation
visual analogue score
0 (no pain) and 100 (worst possible pain)
Measured: 24 th hour after extubation
Secondary outcomes (6)
Total intraoperative opioid consumption
Measured: during the operation
Total postoperative opioid consumption
Measured: 24 hour after operation
Number of patients need postoperative rescue tramadol
Measured: 24 hours after extubation
Time to patient extubation
Measured: at the end of surgery
time for ICU discharge
Measured: 72 hours after surgery
postoperative complication
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start20 Mar 2023
- Primary completion20 Mar 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774249
- Sponsor's protocol ID
- FMASU R34/2023
- Status last verified
- Jul 2023
- First submitted
- 4 Mar 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Adding Pecto-intercostal Fascial Plane Block on the Postoperative Analgesia and Recovery Profile After Off-Pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT05774249
- Acronym / sponsor ID
- FMASU R34/2023
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 17 Mar 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.
Moderate to severe postoperative pain is usually encountered after cardiac surgery.Improper postoperative pain control could have multiple hemodynamic hazards in addition to prolonged postoperative ventilatory support and intensive care unit stay .The safety and efficacy of ultrasound guided chest wall plane blocks has been described for postoperative analgesia after cardiac surgeries.
Study objective: to investigate the effect of adding of pecto-intercostal fascial plane block on the postoperative pain control, perioperative analgesic consumptions and the time for ventilation weaning and intensive care unit discharge in patients who will undergo off-pump Coronary artery bypass surgeries.
Methods: This study patients will be randomly assigned to 2 Groups to receive preoperative ultrasound-guided pecto-intercostal fascial plane block with either 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 or saline bilaterally.
Detailed description
After preoperative patients' anesthesia assessment; the study patients (20 in each group) will receive general anesthesia under invasive monitoring of hemodynamics, and oxygen saturation. After anesthesia induction; cannulation of jugular vein and insertion of transoesophageal echocardiography and temperature probe will be done. In block group : while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally. In control group:Sham Block will be done using 20 mL of normal saline 0.9% bilaterally .
Anesthesia will be maintained with sevoflurane inhalational anesthesia and incremental cisatracurium and fentanyl for intraoperative muscle relaxation and analgesia respectively. Intraoperative anticoagulation will be carried out before revascularization using intravenous heparin titrated according to activated clotting time ,which will be reversed after end of surgery using protamine sulfate.
At the end of surgery patients will be sent to post cardiac surgery intensive care unit . Postoperative analgesia in the form of intravenous paracetamol one gram will be administered on intensive care unit admission then fentanyl based patient controlled analgesia will be started . IV tramadol 1mg/kg as second rescue analgesia will be given if visual analogue scores are still ≥ 4.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided pectointercostal fascial plane block group | Active comparator | Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaineusing 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 |
| control group | Placebo comparator | Procedure: Ultrasound guided pecto-intercostal Fascial Plane Block using normal salineusing 20 mL of normal saline 0.9% |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NYHA ( New york heart association ) class I- III
Key exclusion criteria (9 listed)
- Parents' refusal to study participation.
- Patients with poor coronary vessels targets.
- Patients with poor cardiac systolic function or preoperative hemodynamic unstability
- Redo coronary artery bypass surgery
- Intraoperative complication need conversion to on pump surgery
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 |
|---|---|---|
| Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacainewhile Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of 0.25% bupivacaine with adrenaline 1:400,000 will be administered in increments bilaterally. | Procedure or surgery | Ultrasound guided pectointercostal fascial plane block group |
| Ultrasound guided pecto-intercostal Fascial Plane Block using normal salineSham Block will be done while Patients in supine decubitus position,parasternal area will be scanned using high frequency ultrasound linear probe .After identification of ribs with intercostal spaces in between ;the fourth intercostal space will be approached via 10 cm block needle targeting the plane between pectoralis major and external intercostal muscle under ultrasound guidance after which 20 mL of normal saline 0.9 % will be administered bilaterally. | Procedure or surgery | control group |
Primary outcome
visual analogue score
Time frame: immediately after extubation
0 (no pain) and 10 (worst possible pain)
visual analogue score
Time frame: 1 st hour after extubation
0 (no pain) and 100 (worst possible pain)
visual analogue score
Time frame: 2 nd hour after extubation
0 (no pain) and 100 (worst possible pain)
visual analogue score
Time frame: 4 th hour after extubation
0 (no pain) and 100 (worst possible pain)
visual analogue score
Time frame: 8 th hour after extubation
0 (no pain) and 100 (worst possible pain)
visual analogue score
Time frame: 12 th hour after extubation
0 (no pain) and 100 (worst possible pain)
visual analogue score
Time frame: 18 th hour after extubation
0 (no pain) and 100 (worst possible pain)
visual analogue score
Time frame: 24 th hour after extubation
0 (no pain) and 100 (worst possible pain)
6 secondary outcomes
Total intraoperative opioid consumption
Time frame: during the operation
Total postoperative opioid consumption
Time frame: 24 hour after operation
Number of patients need postoperative rescue tramadol
Time frame: 24 hours after extubation
Time to patient extubation
Time frame: at the end of surgery
time for ICU discharge
Time frame: 72 hours after surgery
postoperative complication
Time frame: 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided pecto-intercostal Fascial Plane Block using bupivacaine and Ultrasound guided pecto-intercostal Fascial Plane Block using normal saline in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
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 9 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: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue score (time frame: immediately after extubation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2023.