Post Operative PainNCT05897307
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve Block
A study testing Ropivacaine in people with Post Operative Pain, run by Fayoum University Hospital at 1 site in Saudi Arabia.
Trial summary
Background: Multimodal analgesia for control of postoperative pain in cardiac surgical patients helps in early recovery and ambulation. Pectoral nerve (PECS) block with ropivacaine is novel, less invasive regional analgesic technique with an effect comparable to paravertebral, and thoracic epidural analgesia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2023to 20 Aug 2024
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- 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
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud University
Riyadh
Mostafa mohammed Elhamamsy, MD, +966568799134 ext. +966, mostafah333@gmail.com
Ahmed Mohamed Aldemerdash, MD, +966567243333 ext. +966, drdemerdash@gmail.com
About this study
Background: Multimodal analgesia for control of postoperative pain in cardiac surgical patients helps in early recovery and ambulation. Pectoral nerve (PECS) block with ropivacaine is novel, less invasive regional analgesic technique with an effect comparable to paravertebral, and thoracic epidural analgesia.
Aim: The aim of this study is to assess the effect of dexmedetomidine as an adjuvant to ropivacaine on the quality and efficiency of the ultra-sound guided pectoralis nerve block in patients undergoing open heart surgery through midline sternotomy for fast-track anesthesia and postoperative analgesia.
Read the detailed description
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 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. [1] PECS I \& II blocks are considered very safe due to the lack of major neurovascular bundles surrounding the area of interest [2, 3].
In 2018 Kumar et al. [4] investigated the efficacy of ultrasound-guided bilateral PECS block for patients undergoing cardiac surgery through midline sternotomy approach. They concluded that Pecs block is technically simple, safe, and very effective technique and can be used as a part of multimodal analgesia in postoperative cardiac surgical patients for better patient comfort and satisfaction and also helps in superior pulmonary rehabilitation, thus assisting in better outcome. [4] With ultrasound guidance, this block has a short learning curve, and because it is superficial block, it is easier to apply, and this is one of the reasons for its increasing use and importance, and it is often performed instead of thoracic epidural block (TEA) and thoracic paravertebral block (TPVB). [4] The current data clearly demonstrates earlier extubation and reduced perioperative narcotic consumption [4-6], which are inherently beneficial for the patient. Adequate pain control is critical for respiratory mechanics and metabolic activity, especially for cardiac patients.
Compared with other regional anesthesia techniques, the ability to perform PECS block in the supine position is a critical advantage as it is convenient to place and should not impact the logistics of the operating room workflow. In addition, it has great potential as a postop analgesic option for cardiac surgeries, possibly as a rescue block. [4] Ropivacaine is a long-acting local anaesthetic agent that is less lipophilic than bupivacaine, and this reduced lipophilicity is associated with decreased potential for central nervous system toxicity and cardiotoxicity. [7] Dexmedetomidine is a potent and highly selective α2-adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, analgesic, anesthetic-reducing and local anesthetic effects. [8] The mechanism of action of dexmedetomidine for potentiation of local anesthetics may be through its central action, α-2 receptor-mediated vasoconstriction, attenuation of inflammatory responses, direct effect on peripheral nerves, or by increasing the activity-dependent hyperpolarization through blocking the hyperpolarization-activated cation (Ih) current. [9] The available preclinical and clinical data propose that the addition of dexmedetomidine with local anesthetics is well tolerated without signs of neurotoxicity. [10] In this study, we hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in prolongation of 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.
Patients and Methods:
After approval of our local ethical committee, and based upon written informed consent, ninety patients, ASA physical statuses III or IV, undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy will be enrolled in the study.
Inclusion criteria:
- Age 20 - 65 years,
- Ejection fraction (EF) > 35%,
- Elective isolated CABG, or Valve surgery
Exclusion criteria:
- 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.
- Conditions
- Post Operative Pain
- Being tested
- Ropivacaine
- Keywords
- cardiac surgery, fast track anesthesia, postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Group (C) | Placebo comparator | will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr. Receives: Drug: Ropivacaine |
| Group (R) | Active comparator | will receive 30 ml of 0.25% of plain ropivacaine for each side. Receives: Drug: Ropivacaine |
| Group (DR) | Active comparator | will receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total postoperative opioid consumption
the total postoperative opioid consumption
Measured: the first 48 hours postoperative
Secondary outcomes (1)
Duration of mechanical ventilation
Duration of mechanical ventilation (day)
Measured: the first 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Aug 2023
- Primary completion10 Aug 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- 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 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897307
- Sponsor's protocol ID
- E-23
- Status last verified
- Sep 2023
- First submitted
- 23 May 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plane
Publications
Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
PubMed 22939099Ueshima H, Otake H. RETRACTED: Ultrasound-guided pectoral nerves (PECS) block: Complications observed in 498 consecutive cases. J Clin Anesth. 2017 Nov;42:46. doi: 10.1016/j.jclinane.2017.08.006. Epub 2017 Aug 9. No abstract available.
PubMed 28802149
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve Block
- ClinicalTrials.gov ID
- NCT05897307
- Acronym / sponsor ID
- E-23
- Conditions
- Post Operative Pain
- Keywords
- cardiac surgery, fast track anesthesia, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 9 Jun 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.
Background: Multimodal analgesia for control of postoperative pain in cardiac surgical patients helps in early recovery and ambulation. Pectoral nerve (PECS) block with ropivacaine is novel, less invasive regional analgesic technique with an effect comparable to paravertebral, and thoracic epidural analgesia.
Aim: The aim of this study is to assess the effect of dexmedetomidine as an adjuvant to ropivacaine on the quality and efficiency of the ultra-sound guided pectoralis nerve block in patients undergoing open heart surgery through midline sternotomy for fast-track anesthesia and postoperative analgesia.
Detailed description
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 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. [1] PECS I \& II blocks are considered very safe due to the lack of major neurovascular bundles surrounding the area of interest [2, 3].
In 2018 Kumar et al. [4] investigated the efficacy of ultrasound-guided bilateral PECS block for patients undergoing cardiac surgery through midline sternotomy approach. They concluded that Pecs block is technically simple, safe, and very effective technique and can be used as a part of multimodal analgesia in postoperative cardiac surgical patients for better patient comfort and satisfaction and also helps in superior pulmonary rehabilitation, thus assisting in better outcome. [4] With ultrasound guidance, this block has a short learning curve, and because it is superficial block, it is easier to apply, and this is one of the reasons for its increasing use and importance, and it is often performed instead of thoracic epidural block (TEA) and thoracic paravertebral block (TPVB). [4] The current data clearly demonstrates earlier extubation and reduced perioperative narcotic consumption [4-6], which are inherently beneficial for the patient. Adequate pain control is critical for respiratory mechanics and metabolic activity, especially for cardiac patients.
Compared with other regional anesthesia techniques, the ability to perform PECS block in the supine position is a critical advantage as it is convenient to place and should not impact the logistics of the operating room workflow. In addition, it has great potential as a postop analgesic option for cardiac surgeries, possibly as a rescue block. [4] Ropivacaine is a long-acting local anaesthetic agent that is less lipophilic than bupivacaine, and this reduced lipophilicity is associated with decreased potential for central nervous system toxicity and cardiotoxicity. [7] Dexmedetomidine is a potent and highly selective α2-adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, analgesic, anesthetic-reducing and local anesthetic effects. [8] The mechanism of action of dexmedetomidine for potentiation of local anesthetics may be through its central action, α-2 receptor-mediated vasoconstriction, attenuation of inflammatory responses, direct effect on peripheral nerves, or by increasing the activity-dependent hyperpolarization through blocking the hyperpolarization-activated cation (Ih) current. [9] The available preclinical and clinical data propose that the addition of dexmedetomidine with local anesthetics is well tolerated without signs of neurotoxicity. [10] In this study, we hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in prolongation of 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.
Patients and Methods:
After approval of our local ethical committee, and based upon written informed consent, ninety patients, ASA physical statuses III or IV, undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy will be enrolled in the study.
Inclusion criteria:
- Age 20 - 65 years,
- Ejection fraction (EF) > 35%,
- Elective isolated CABG, or Valve surgery
Exclusion criteria:
- 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.
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 (C) | Placebo comparator | Drug: Ropivacainewill not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr. |
| Group (R) | Active comparator | Drug: Ropivacainewill receive 30 ml of 0.25% of plain ropivacaine for each side. |
| Group (DR) | Active comparator | Drug: Ropivacainewill receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Ropivacainedexmedetomidine | Drug | Group (C), Group (DR), Group (R) |
Primary outcome
the total postoperative opioid consumption
Time frame: the first 48 hours postoperative
the total postoperative opioid consumption
1 secondary outcome
Duration of mechanical ventilation
Time frame: the first 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 22939099Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
- Background: PubMed 28802149Ueshima H, Otake H. RETRACTED: Ultrasound-guided pectoral nerves (PECS) block: Complications observed in 498 consecutive cases. J Clin Anesth. 2017 Nov;42:46. doi: 10.1016/j.jclinane.2017.08.006. Epub 2017 Aug 9. No abstract available.
- Individual participant dataSharing planned: No. no plane
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Post Operative Pain, run by Fayoum University Hospital at 1 site in Saudi Arabia.
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 13 Sep 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ahmed Hamed, MD (01010509736 ext. 002, mah07@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total postoperative opioid consumption (time frame: the first 48 hours postoperative). 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 NCT05897307, which also lists 2 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 13 Sep 2023.