Postoperative PainPhase 4NCT05590013
Effect of Pectointercostal+ESP Block on Postoperatif Analgesia in Open Heart Surgery
A Phase 4 study testing Pectointercostal and ESP block in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pectointercostal and ESP block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Aug 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II-III patients
- The patients who will operate for open heart surgery
Who cannot join
- The patients with Coagulopaty
- Allergy with local anesthetics
- infection at the injection sites
- Obesity (BMI >35kg/m2)
- Liver and/or kidney failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cukurova University
Adana, 01380
Ebru Biricik, MD, 05052420223, ebrubiricik01@gmail.com
About this study
Official title: Determining to the Effect of Pectointercostal and ESP Block on Postoperative Analgesia During Open Heart Surgery
American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. Totally bupivacaine %0.25 2.5 mg/kg will use blocks and 1 ml epinephrin will add to the each local anesthetic solutions. 10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain assessment will perform with visual analog scale (VAS)
Read the detailed description
American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block and block will not perform to the control group. Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks and 1 ml epinephrin will add to the each local anesthetic solutions in each side.10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain assessment will perform with visual analog scale (VAS). VAS, morphine consumption and complications will record.Paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. The patient controlled anesthesia with morphin will apply to the all patients. If the VAS score is higher than 4, the rescue analgesic diclofenac Na 75 mg will administer intravenously.
- Conditions
- Postoperative Pain
- Being tested
- Pectointercostal and ESP block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectointercostal and ESP blockDrug
Also called Fascial plane blocks
Pectointercostal plane block will apply at the 4-5. intercostal space and ESP block will apply athe T6 level bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Pectointercostal and ESP | Active comparator | Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block . Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks and 1 ml epinephrin will add to the each local anesthetic solutions in each side.10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. Receives: Drug: Pectointercostal and ESP block |
| Control Group | Placebo comparator | Block will not perform to the control group. Receives: Drug: Pectointercostal and ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Visual analog scale (VAS) scores at the postoperative 24th hours. VAS scores define pain scores between 0-10. 0 reflects nopain, 10 reflects the worst pain.
Measured: 24 hours in Postanesthesia care unit (PACU)
Morphine consumption
Postoperative morphine consumption during the postoperative 24th hours
Measured: 24 hours in Postanesthesia care unit (PACU)
Secondary outcomes (1)
Ekstübation time
Time between end of the surgery and extubation of the patient
Measured: First 6 hours at Postanesthesia care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start15 Nov 2022
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
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 Cukurova 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru biricik, Cukurova University
- Investigators
- Ebru Biricik, Study chair, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590013
- Sponsor's protocol ID
- Pectointercostal and ESP block
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining to the Effect of Pectointercostal and ESP Block on Postoperative Analgesia During Open Heart Surgery
- ClinicalTrials.gov ID
- NCT05590013
- Acronym / sponsor ID
- Pectointercostal and ESP block
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 21 Oct 2022 (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.
American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. Totally bupivacaine %0.25 2.5 mg/kg will use blocks and 1 ml epinephrin will add to the each local anesthetic solutions. 10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain assessment will perform with visual analog scale (VAS)
Detailed description
American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block and block will not perform to the control group. Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks and 1 ml epinephrin will add to the each local anesthetic solutions in each side.10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain assessment will perform with visual analog scale (VAS). VAS, morphine consumption and complications will record.Paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. The patient controlled anesthesia with morphin will apply to the all patients. If the VAS score is higher than 4, the rescue analgesic diclofenac Na 75 mg will administer intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectointercostal and ESP | Active comparator | Drug: Pectointercostal and ESP blockUltrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block . Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks and 1 ml epinephrin will add to the each local anesthetic solutions in each side.10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. |
| Control Group | Placebo comparator | Drug: Pectointercostal and ESP blockBlock will not perform to the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA II-III patients
- The patients who will operate for open heart surgery
Key exclusion criteria (5 listed)
- The patients with Coagulopaty
- Allergy with local anesthetics
- infection at the injection sites
- Obesity (BMI >35kg/m2)
- Liver and/or kidney failure
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 and ESP blockAlso: Fascial plane blocksPectointercostal plane block will apply at the 4-5. intercostal space and ESP block will apply athe T6 level bilaterally | Drug | Control Group, Pectointercostal and ESP |
Primary outcome
Postoperative analgesia
Time frame: 24 hours in Postanesthesia care unit (PACU)
Visual analog scale (VAS) scores at the postoperative 24th hours. VAS scores define pain scores between 0-10. 0 reflects nopain, 10 reflects the worst pain.
Morphine consumption
Time frame: 24 hours in Postanesthesia care unit (PACU)
Postoperative morphine consumption during the postoperative 24th hours
1 secondary outcome
Ekstübation time
Time frame: First 6 hours at Postanesthesia care unit (PACU)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Ebru Biricik study chair
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pectointercostal and ESP block in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 27 Apr 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 Turkey (Türkiye). 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 Ebru Biricik (+905052420223, ebrubiricik01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: 24 hours in Postanesthesia care unit (PACU)). 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?
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 27 Apr 2023.