Postoperative PainNCT04872192
Analgesic Efficacy of Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain
A study testing transversus thoracic muscle plane block and general anaesthesia in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Patients were randomly allocated to either Tansversus group (T group) and general anesthesia (N group).Patient demographic data, preoperative medical status, left ventricular function, and operative data (total ischemic time, number of grafts) were recorded. Read more about this study
- Who is it for?
- Ages 55 to 74 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- transversus thoracic muscle plane block and general anaesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 27 May 2021to 18 Aug 2021
- 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 55 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 55-74 years
- ASA II-III
- BMI<30
Who cannot join
- patients who were preoperatively intubated for more than 24 hours
- patients with complex cardiac procedures
- patient inability to communicate patients with severe pulmonary hypertension in addition to any contraindication to regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-guided Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain: a Randomized Controlled Trial
Patients were randomly allocated to either Tansversus group (T group) and general anesthesia (N group).Patient demographic data, preoperative medical status, left ventricular function, and operative data (total ischemic time, number of grafts) were recorded. The primary outcome of the study was Percentage of patients needed additional doses of morphine . The secondary outcomes included postoperative visual analogue pain scores performed after patient extubation for pain assessment at rest (0 = no pain, 10 = maximum unbearable pain) at time of extubation, 8h, 12 h,18 h and 24 hours postoperatively were recorded, when pain score >4, patients were given morphine 0.05 mg/kg administered by a physician who was blinded to the nature of the study, time needed for first rescue analgesic, postoperative blood pressure and heart rate were recorded immediately on admission then 2 hours, 4 hours, 6 hours, 12 and 24 hours postoperatively, in addition to extubation time, length of ICU stay, the incidence of complications related to the technique such as hemothorax or pneumothorax, arrhythmias, and local anesthetic toxicity were recorded. The end-point was difficult weaning from cardiopulmonary bypass, major postoperative bleeding which required re-exploration or allergy to any agents needed for anesthesia. All complications were managed according to surgical and medical guidelines.
Read the detailed description
Patients were randomly allocated to either Tansversus group (T group) and general anesthesia (N group). The patients were randomized using a computer-generated random number in various block sizes in 1:1 ratio. Randomisation was done using the SAS statistical package version 9.3 (SAS institute, Cary, NC, USA) by a statistician who was not involved in the study.
In the Tansversus group (n=30), prior to surgical incision, a 12 L-RS linear probe of the Sonosite M Turbo ultrasound system (National electrical manufacturers, USA). Probe was put beneath the clavicle next to the sternal edge and the second rib was visualized. Sliding the probe on the ribs downward till reaching the fifth rib. The probe was rotated 90 degrees and placed in the fouth intercostal space between the fourth and fifth ribs at the edge of the sternum. A 20-gauge Tuohy needle was introduced from lateral-to-medial in the plane between the internal intercostal muscles IIM and the transversus thoracic muscle TTM. Injection of 1 mL of normal saline was done to identify this plane followed by injection of 15 ml bupivacaine 0.25% on each side and observation of the local anesthetic spread, and pushing on the pleura confirmed the correct injection of the local anesthetic. This technique was done on the other side. It is important to identify the internal mammary artery IMA which was visualized as a hypoechoic pulsatile structure to avoid inadvertent puncture of the artery and subsequent bleeding and proper visualization of the IMA can facilitate the block. In N group (n=30), the same bilateral technique was done on both sides and 15 ml saline was injected during each side of TTPB technique. All the blocks were done by a single experienced anesthetist. Drug packs were prepared before commencement of the study by a pharmacist who was unaware of the nature of the study Hemodynamic changes, such as high blood pressure or significant tachycardia, additional 0.5- to-1 micrograms/kg IV doses of fentanyl were administered.
Median sternotomy was performed in all cardiac surgical procedures. At the end of the cardiac surgical procedure, all patients were transferred to the ICU after surgery to maintain the hemodynamics, warming them up with control of bleeding and correction of hemoglobin level, serum electrolytes and acid-base balance. A standard postoperative analgesia was accomplished by acetaminophen 1 gm/6 hours.The protocol for postoperative care was implemented for all patients by well-trained, qualified bedside nurses supervised 1:1 by well-trained ICU consultants. All patients were extubated when deemed clinically appropriate according to the local ICU protocol, by ICU staff, when the patient was able to maintain spontaneous breathing after extubation. The patients were encouraged to sit on a chair and mobilize with the assistance of health care providers in the ICU then the physiotherapist became responsible for improving mobility and rehabilitation of the patients till discharge from the hospital.
Patient demographic data, preoperative medical status, left ventricular function, and operative data (total ischemic time, number of grafts) were recorded. The primary outcome of the study was Percentage of patients needed additional doses of morphine The secondary outcomes included total dose of morphine requirements, postoperative visual analogue pain scores performed after patient extubation for pain assessment at rest (0 = no pain, 10 = maximum unbearable pain) at time of extubation, 8h, 12 h,18 h and 24 hours postoperatively were recorded, when pain score >4, patients were given morphine 0.05 mg/kg administered by a physician who was blinded to the nature of the study, time needed for first rescue analgesic, postoperative blood pressure and heart rate were recorded immediately on admission then 2 hours, 4 hours, 6 hours, 12 and 24 hours postoperatively, in addition to extubation time, length of ICU stay, the incidence of complications related to the technique such as hemothorax or pneumothorax, arrhythmias, and local anesthetic toxicity were recorded. The end-point was difficult weaning from cardiopulmonary bypass, major postoperative bleeding which required re-exploration or allergy to any agents needed for anesthesia. All complications were managed according to surgical and medical guidelines.
- Conditions
- Postoperative Pain
- Being tested
- transversus thoracic muscle plane block, general anaesthesia
- Keywords
- transversus thoracic muscle block, adults, cardiac surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus thoracic muscle plane blockOther
transversus thoracic muscle plane block by injection of 15 ml of bupivacaine 0.25% on each side combined with general anaesthesia
general anaesthesiaOther
transversus thoracic muscle plane block by injection of 15 ml of saline on each side combined with general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| transversus | Active comparator | patients received transversus thoracic muscle plane block and injection of 15 ml bupivacaine 0.25% on each side. Receives: Other: transversus thoracic muscle plane block |
| general anaesthesia group | Sham comparator | the same bilateral technique was done on both sides and 15 ml saline was injected during each side of TTPB technique. Receives: Other: general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients needed additional doses of morphine
number of patients requiring additional doses of morphine
Measured: 24 hours postoperative
Secondary outcomes (2)
postoperative visual analogue pain scores
pain assessment at rest (0 = no pain, 10 = maximum unbearable pain)
Measured: time of extubation, 8 hours, 12 hours,18 hours and 24 hours postoperatively
postoperative total morphine dose
dose of postoperative rescue morphine requirements
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start27 May 2021
- Primary completion31 Jul 2021
- Study completion18 Aug 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Shokri, Ain Shams University
- Investigators
- Hoda Shokri, Principal investigator, Ain Shams UniversityIhab Ali, Study director, AinShams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872192
- Sponsor's protocol ID
- FMASU R 20/ 2020/ 2021
- Status last verified
- Oct 2021
- First submitted
- 2 May 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-guided Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04872192
- Acronym / sponsor ID
- FMASU R 20/ 2020/ 2021
- Conditions
- Postoperative Pain
- Keywords
- transversus thoracic muscle block, adults, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 4 May 2021 (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.
Patients were randomly allocated to either Tansversus group (T group) and general anesthesia (N group).Patient demographic data, preoperative medical status, left ventricular function, and operative data (total ischemic time, number of grafts) were recorded. The primary outcome of the study was Percentage of patients needed additional doses of morphine . The secondary outcomes included postoperative visual analogue pain scores performed after patient extubation for pain assessment at rest (0 = no pain, 10 = maximum unbearable pain) at time of extubation, 8h, 12 h,18 h and 24 hours postoperatively were recorded, when pain score >4, patients were given morphine 0.05 mg/kg administered by a physician who was blinded to the nature of the study, time needed for first rescue analgesic, postoperative blood pressure and heart rate were recorded immediately on admission then 2 hours, 4 hours, 6 hours, 12 and 24 hours postoperatively, in addition to extubation time, length of ICU stay, the incidence of complications related to the technique such as hemothorax or pneumothorax, arrhythmias, and local anesthetic toxicity were recorded. The end-point was difficult weaning from cardiopulmonary bypass, major postoperative bleeding which required re-exploration or allergy to any agents needed for anesthesia. All complications were managed according to surgical and medical guidelines.
Detailed description
Patients were randomly allocated to either Tansversus group (T group) and general anesthesia (N group). The patients were randomized using a computer-generated random number in various block sizes in 1:1 ratio. Randomisation was done using the SAS statistical package version 9.3 (SAS institute, Cary, NC, USA) by a statistician who was not involved in the study.
In the Tansversus group (n=30), prior to surgical incision, a 12 L-RS linear probe of the Sonosite M Turbo ultrasound system (National electrical manufacturers, USA). Probe was put beneath the clavicle next to the sternal edge and the second rib was visualized. Sliding the probe on the ribs downward till reaching the fifth rib. The probe was rotated 90 degrees and placed in the fouth intercostal space between the fourth and fifth ribs at the edge of the sternum. A 20-gauge Tuohy needle was introduced from lateral-to-medial in the plane between the internal intercostal muscles IIM and the transversus thoracic muscle TTM. Injection of 1 mL of normal saline was done to identify this plane followed by injection of 15 ml bupivacaine 0.25% on each side and observation of the local anesthetic spread, and pushing on the pleura confirmed the correct injection of the local anesthetic. This technique was done on the other side. It is important to identify the internal mammary artery IMA which was visualized as a hypoechoic pulsatile structure to avoid inadvertent puncture of the artery and subsequent bleeding and proper visualization of the IMA can facilitate the block. In N group (n=30), the same bilateral technique was done on both sides and 15 ml saline was injected during each side of TTPB technique. All the blocks were done by a single experienced anesthetist. Drug packs were prepared before commencement of the study by a pharmacist who was unaware of the nature of the study Hemodynamic changes, such as high blood pressure or significant tachycardia, additional 0.5- to-1 micrograms/kg IV doses of fentanyl were administered.
Median sternotomy was performed in all cardiac surgical procedures. At the end of the cardiac surgical procedure, all patients were transferred to the ICU after surgery to maintain the hemodynamics, warming them up with control of bleeding and correction of hemoglobin level, serum electrolytes and acid-base balance. A standard postoperative analgesia was accomplished by acetaminophen 1 gm/6 hours.The protocol for postoperative care was implemented for all patients by well-trained, qualified bedside nurses supervised 1:1 by well-trained ICU consultants. All patients were extubated when deemed clinically appropriate according to the local ICU protocol, by ICU staff, when the patient was able to maintain spontaneous breathing after extubation. The patients were encouraged to sit on a chair and mobilize with the assistance of health care providers in the ICU then the physiotherapist became responsible for improving mobility and rehabilitation of the patients till discharge from the hospital.
Patient demographic data, preoperative medical status, left ventricular function, and operative data (total ischemic time, number of grafts) were recorded. The primary outcome of the study was Percentage of patients needed additional doses of morphine The secondary outcomes included total dose of morphine requirements, postoperative visual analogue pain scores performed after patient extubation for pain assessment at rest (0 = no pain, 10 = maximum unbearable pain) at time of extubation, 8h, 12 h,18 h and 24 hours postoperatively were recorded, when pain score >4, patients were given morphine 0.05 mg/kg administered by a physician who was blinded to the nature of the study, time needed for first rescue analgesic, postoperative blood pressure and heart rate were recorded immediately on admission then 2 hours, 4 hours, 6 hours, 12 and 24 hours postoperatively, in addition to extubation time, length of ICU stay, the incidence of complications related to the technique such as hemothorax or pneumothorax, arrhythmias, and local anesthetic toxicity were recorded. The end-point was difficult weaning from cardiopulmonary bypass, major postoperative bleeding which required re-exploration or allergy to any agents needed for anesthesia. All complications were managed according to surgical and medical guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus | Active comparator | Other: transversus thoracic muscle plane blockpatients received transversus thoracic muscle plane block and injection of 15 ml bupivacaine 0.25% on each side. |
| general anaesthesia group | Sham comparator | Other: general anaesthesiathe same bilateral technique was done on both sides and 15 ml saline was injected during each side of TTPB technique. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 55-74 years
- ASA II-III
- BMI<30
Key exclusion criteria (3 listed)
- patients who were preoperatively intubated for more than 24 hours
- patients with complex cardiac procedures
- patient inability to communicate patients with severe pulmonary hypertension in addition to any contraindication to regional anesthesia
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 |
|---|---|---|
| transversus thoracic muscle plane blocktransversus thoracic muscle plane block by injection of 15 ml of bupivacaine 0.25% on each side combined with general anaesthesia | Other | transversus |
| general anaesthesiatransversus thoracic muscle plane block by injection of 15 ml of saline on each side combined with general anaesthesia | Other | general anaesthesia group |
Primary outcome
Percentage of patients needed additional doses of morphine
Time frame: 24 hours postoperative
number of patients requiring additional doses of morphine
2 secondary outcomes
postoperative visual analogue pain scores
Time frame: time of extubation, 8 hours, 12 hours,18 hours and 24 hours postoperatively
postoperative total morphine dose
Time frame: 24 hours postoperative
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 11 Oct 2021.
- Individual participant dataSharing planned: Yes. study protocol
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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.
Hoda Shokri principal investigator
Ain Shams University
Ihab Ali study director
AinShams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transversus thoracic muscle plane block and general anaesthesia 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 3 inclusion and 3 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 11 Oct 2021. 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?
Percentage of patients needed additional doses of morphine (time frame: 24 hours postoperative). 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 11 Oct 2021.