AnalgesiaPhase 4NCT06636578
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block
A Phase 4 study testing dexmedetomidine, ropivacaine and fentanyl in people with Analgesia, run by Fayoum University at 2 sites in Egypt.
Trial summary
In 2012 Blanco et al. [1] described the ultrasound technique for Pectoral nerve (PECS) block as a new, less invasive regional analgesic technique for breast surgeries. PECS block includes PECS I and PECS II (modified PECS I) interfascial blocks. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- dexmedetomidine, ropivacaine and fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Oct 2024to 8 Jan 2025
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20 - 65 years,
- Ejection fraction (EF) > 35%,
- Elective isolated CABG, or Valve surgery
Who cannot join
- Poor left ventricular function with intra-aortic balloon pump support,
- Recent myocardial infarction (last seven days),
- Combined procedure (i.e., CABG + other heart/vascular procedure),
- Emergency surgery, or Redo cases,
- Hepatic or renal failure, creatinine >1.5,
- Patients with hemodynamic instability, preexisting infection at the site of block, allergy to local anesthetics, psychiatric illness, and patients with prolonged postoperative ventilatory course were excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Completed
Fayoum University Hospital
Al Fayyum, 63511
- Recruiting
Mohamed Hamed
Al Fayyum, 63511
mohadme a hamed, MD, 01118560065 ext. +20, dhamed81@yahoo.com
mohamed a hamed, MD
About this study
Official title: Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block for Fast Tracking and Postoperative Analgesia in Open Heart Surgery Through Midline Sternotomy. A Randomized Clinical Trial
In 2012 Blanco et al. [1] described the ultrasound technique for Pectoral nerve (PECS) block as a new, less invasive regional analgesic technique for breast surgeries.
PECS block includes PECS I and PECS II (modified PECS I) interfascial blocks. Since that time, PECS block has been used successfully with good results for a wide variety of surgeries on the chest wall such as radical mastectomies, breast-conserving surgeries, breast implant placement, automated implantable cardioverter-defibrillator (AICD)/pacemaker placement, intercostal drainage tube placement, and rib fractures. In this study, the investigators hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in the prolongation of the duration of anesthesia with improvement of the quality of postoperative analgesia of bilateral PECS block for patients undergoing cardiac surgery via midline sternotomy compared with using only plain ropivacaine.
Read the detailed description
This study will be performed at the FAYOUM University Hospital after approval from the local Institutional Ethics Committee and the local Institutional Review Board. It will be a double-blind randomized controlled study. The eligible patients will sign a detailed informed consent form before recruitment and randomization.
After confirming hemodynamic stability, satisfactory blood gasses, electrolytes, normalized activated coagulation time (ACT < 120 s), and minimal drain output, bilateral PECS block will be performed guided by a linear ultrasound transducer (12 MHz). 5
The block will be performed in a supine position with the arm slightly abducted. Under complete aseptic precautions, and using a 20 gauge 5 cm needle. The ultrasound probe will be placed at the midclavicular level inferolaterally to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major, pectoralis minor, and serratus anterior muscles were identified at the level of the fourth rib.
The needle will be inserted in the plane concerning the ultrasound probe. A volume of 20 ml of local anesthetic solution will be deposited in the fascial plane between pectoralis minor and serratus anterior muscle, followed by withdrawal of the needle to the fascial plane between pectoralis major and pectoralis minor muscle, where a volume of 10 ml will be deposited. The block will be performed similarly on both sides. It will be noted that the total dose of local anesthetic is not to exceed the toxic dose of ropivacaine (3 mg/kg). Patients then will be transferred intubated to the Surgical ICU (SICU), and standard monitoring will be continued until patients are fully awake, patients will be extubated once they fulfilled the extubation criteria.
Sample Size ( number of participants included ) 90 patients
Methodology in detail:
All patients will receive a slandered anesthesia technique. The main goal of the anesthesia technique will be to ensure a rapid return of consciousness and protective reflexes, with minimal residual sedative effects, and importantly, it should facilitate early ambulation. Continuous infusion of fentanyl, midazolam, and rocuronium as total intravenous anesthesia (TIVA).
At the end of the surgery, TIVA will be stopped, and paracetamol 1 gm IV infusion over 15 min will be administered with closure of the sternum.
After dressing, Patients will be randomly allocated into three groups:
Group (C) control group (n = 30): will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr.
For the other two groups, regional anesthesia will be used, and every patient in these two groups will receive 20 ml of ropivacaine 0.25% will be used by the surgeon for infiltration in the surgical incision site and in the skin around the mediastinal drains. In addition, every patient in these two groups will receive bilateral ultrasound-guided PECS block as follows:
Group (R) (n = 30): will receive 30 ml of 0.25% of plain ropivacaine for each side.
Group (DR) (n = 30): will receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side.
Measured data:
- pain assessment will be done using the VAS scoring system (On a pain scale [0-10] at rest and during cough by an intensivist blinded to the study groups at 0 h (at extubation) and thereafter at 3, 6, 12, 18, and 24 h intervals. Pain will be classified into mild, moderate, and severe for analysis (mild VAS 0-4, moderate VAS 5-7, and severe VAS >8).
- Duration of mechanical ventilation.
- total dose of fentanyl used for breakthrough pain.
- incidence of any complications.
- duration of ICU stay.
- Patient's satisfaction level will be assessed with a Likert five-item scoring system
- Conditions
- Analgesia
- Being tested
- dexmedetomidine, ropivacaine, fentanyl
- Keywords
- PECS block, analgesia after median sternotomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called precedex
will receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side.
ropivacaineDrug
Also called plain ropivacaine
will receive 30 ml of 0.25% of plain ropivacaine for each side.
fentanylDrug
will not receive any regional anesthesia and only will receive I.V. fentanyl 1μg/kg/hr.
| Study group | Role | What they receive |
|---|---|---|
| Group (DR) | Active comparator | will receive 30 ml of 0.25% ropivacaine + dexmedetomidine 0.5 μg/kg for each side. Receives: Drug: dexmedetomidine; Drug: ropivacaine |
| Group (R) | Active comparator | will receive 30 ml of 0.25% of plain ropivacaine for each side. Receives: Drug: ropivacaine |
| Group (C) | Sham comparator | the control group will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr. Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment will be done using VAS scoring system
(In a pain scale [0-10] at rest and during cough by an intensivist blinded to the study groups at 0 h (at extubation) and thereafter at 3, 6, 12, 18, and 24 h intervals. Pain will be classified into mild, moderate, and severe for analysis (mild VAS 0-4, moderate VAS 5-7, and severe VAS >8)
Measured: The first 24 hours postoperative
Total opioid consumption
the amount of opioid (mostly used is fentanyl amp. in equivalent doses ) that has been used for 24 hours after admission in ICU
Measured: from the time of ICU admission hour 1 up to hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start10 Oct 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion8 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Fayoum 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University
- Investigators
- mohamed hamed, M.D, Principal investigator, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636578
- Sponsor's protocol ID
- R 611
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sertcakacilar G, Tire Y, Kelava M, Nair HK, Lawin-O'Brien ROC, Turan A, Ruetzler K. Regional anesthesia for thoracic surgery: a narrative review of indications and clinical considerations. J Thorac Dis. 2022 Dec;14(12):5012-5028. doi: 10.21037/jtd-22-599.
PubMed 36647492Kumar KN, Kalyane RN, Singh NG, Nagaraja PS, Krishna M, Babu B, Varadaraju R, Sathish N, Manjunatha N. Efficacy of bilateral pectoralis nerve block for ultrafast tracking and postoperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):333-338. doi: 10.4103/aca.ACA_15_18.
PubMed 30052231Yalamuri S, Klinger RY, Bullock WM, Glower DD, Bottiger BA, Gadsden JC. Pectoral Fascial (PECS) I and II Blocks as Rescue Analgesia in a Patient Undergoing Minimally Invasive Cardiac Surgery. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):764-766. doi: 10.1097/AAP.0000000000000661.
PubMed 29016551
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block for Fast Tracking and Postoperative Analgesia in Open Heart Surgery Through Midline Sternotomy. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06636578
- Acronym / sponsor ID
- R 611
- Conditions
- Analgesia
- Keywords
- PECS block, analgesia after median sternotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 8 Jan 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
In 2012 Blanco et al. [1] described the ultrasound technique for Pectoral nerve (PECS) block as a new, less invasive regional analgesic technique for breast surgeries.
PECS block includes PECS I and PECS II (modified PECS I) interfascial blocks. Since that time, PECS block has been used successfully with good results for a wide variety of surgeries on the chest wall such as radical mastectomies, breast-conserving surgeries, breast implant placement, automated implantable cardioverter-defibrillator (AICD)/pacemaker placement, intercostal drainage tube placement, and rib fractures. In this study, the investigators hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in the prolongation of the duration of anesthesia with improvement of the quality of postoperative analgesia of bilateral PECS block for patients undergoing cardiac surgery via midline sternotomy compared with using only plain ropivacaine.
Detailed description
This study will be performed at the FAYOUM University Hospital after approval from the local Institutional Ethics Committee and the local Institutional Review Board. It will be a double-blind randomized controlled study. The eligible patients will sign a detailed informed consent form before recruitment and randomization.
After confirming hemodynamic stability, satisfactory blood gasses, electrolytes, normalized activated coagulation time (ACT < 120 s), and minimal drain output, bilateral PECS block will be performed guided by a linear ultrasound transducer (12 MHz). 5
The block will be performed in a supine position with the arm slightly abducted. Under complete aseptic precautions, and using a 20 gauge 5 cm needle. The ultrasound probe will be placed at the midclavicular level inferolaterally to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major, pectoralis minor, and serratus anterior muscles were identified at the level of the fourth rib.
The needle will be inserted in the plane concerning the ultrasound probe. A volume of 20 ml of local anesthetic solution will be deposited in the fascial plane between pectoralis minor and serratus anterior muscle, followed by withdrawal of the needle to the fascial plane between pectoralis major and pectoralis minor muscle, where a volume of 10 ml will be deposited. The block will be performed similarly on both sides. It will be noted that the total dose of local anesthetic is not to exceed the toxic dose of ropivacaine (3 mg/kg). Patients then will be transferred intubated to the Surgical ICU (SICU), and standard monitoring will be continued until patients are fully awake, patients will be extubated once they fulfilled the extubation criteria.
Sample Size ( number of participants included ) 90 patients
Methodology in detail:
All patients will receive a slandered anesthesia technique. The main goal of the anesthesia technique will be to ensure a rapid return of consciousness and protective reflexes, with minimal residual sedative effects, and importantly, it should facilitate early ambulation. Continuous infusion of fentanyl, midazolam, and rocuronium as total intravenous anesthesia (TIVA).
At the end of the surgery, TIVA will be stopped, and paracetamol 1 gm IV infusion over 15 min will be administered with closure of the sternum.
After dressing, Patients will be randomly allocated into three groups:
Group (C) control group (n = 30): will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr.
For the other two groups, regional anesthesia will be used, and every patient in these two groups will receive 20 ml of ropivacaine 0.25% will be used by the surgeon for infiltration in the surgical incision site and in the skin around the mediastinal drains. In addition, every patient in these two groups will receive bilateral ultrasound-guided PECS block as follows:
Group (R) (n = 30): will receive 30 ml of 0.25% of plain ropivacaine for each side.
Group (DR) (n = 30): will receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side.
Measured data:
- pain assessment will be done using the VAS scoring system (On a pain scale [0-10] at rest and during cough by an intensivist blinded to the study groups at 0 h (at extubation) and thereafter at 3, 6, 12, 18, and 24 h intervals. Pain will be classified into mild, moderate, and severe for analysis (mild VAS 0-4, moderate VAS 5-7, and severe VAS >8).
- Duration of mechanical ventilation.
- total dose of fentanyl used for breakthrough pain.
- incidence of any complications.
- duration of ICU stay.
- Patient's satisfaction level will be assessed with a Likert five-item scoring system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (DR) | Active comparator | Drug: dexmedetomidine, Drug: ropivacainewill receive 30 ml of 0.25% ropivacaine + dexmedetomidine 0.5 μg/kg for each side. |
| Group (R) | Active comparator | Drug: ropivacainewill receive 30 ml of 0.25% of plain ropivacaine for each side. |
| Group (C) | Sham comparator | Drug: fentanylthe control group will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20 - 65 years,
- Ejection fraction (EF) > 35%,
- Elective isolated CABG, or Valve surgery
Key exclusion criteria (6 listed)
- Poor left ventricular function with intra-aortic balloon pump support,
- Recent myocardial infarction (last seven days),
- Combined procedure (i.e., CABG + other heart/vascular procedure),
- Emergency surgery, or Redo cases,
- Hepatic or renal failure, creatinine >1.5,
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 |
|---|---|---|
| dexmedetomidineAlso: precedexwill receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side. | Drug | Group (DR) |
| ropivacaineAlso: plain ropivacainewill receive 30 ml of 0.25% of plain ropivacaine for each side. | Drug | Group (DR), Group (R) |
| fentanylwill not receive any regional anesthesia and only will receive I.V. fentanyl 1μg/kg/hr. | Drug | Group (C) |
Primary outcome
pain assessment will be done using VAS scoring system
Time frame: The first 24 hours postoperative
(In a pain scale [0-10] at rest and during cough by an intensivist blinded to the study groups at 0 h (at extubation) and thereafter at 3, 6, 12, 18, and 24 h intervals. Pain will be classified into mild, moderate, and severe for analysis (mild VAS 0-4, moderate VAS 5-7, and severe VAS >8)
Total opioid consumption
Time frame: from the time of ICU admission hour 1 up to hour 24
the amount of opioid (mostly used is fentanyl amp. in equivalent doses ) that has been used for 24 hours after admission in ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 36647492Sertcakacilar G, Tire Y, Kelava M, Nair HK, Lawin-O'Brien ROC, Turan A, Ruetzler K. Regional anesthesia for thoracic surgery: a narrative review of indications and clinical considerations. J Thorac Dis. 2022 Dec;14(12):5012-5028. doi: 10.21037/jtd-22-599.
- Background: PubMed 30052231Kumar KN, Kalyane RN, Singh NG, Nagaraja PS, Krishna M, Babu B, Varadaraju R, Sathish N, Manjunatha N. Efficacy of bilateral pectoralis nerve block for ultrafast tracking and postoperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):333-338. doi: 10.4103/aca.ACA_15_18.
- Background: PubMed 29016551Yalamuri S, Klinger RY, Bullock WM, Glower DD, Bottiger BA, Gadsden JC. Pectoral Fascial (PECS) I and II Blocks as Rescue Analgesia in a Patient Undergoing Minimally Invasive Cardiac Surgery. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):764-766. doi: 10.1097/AAP.0000000000000661.
- Individual participant dataSharing planned: No
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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.
mohamed hamed, M.D principal investigator
Fayoum University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine, ropivacaine and fentanyl in people with Analgesia, run by Fayoum University at 2 sites 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 3 inclusion and 6 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 mina fam, M.D (01025273637, mms12@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assessment will be done using VAS scoring system (time frame: The first 24 hours postoperative). The study lists 2 primary outcomes in all. 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 NCT06636578, which also lists 3 linked publications.
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 15 Oct 2024.