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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Ain shams university

    Cairo, 11566

Other trials in Egypt

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.

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 groups in NCT04872192
Study groupRoleWhat they receive
transversusActive comparatorpatients 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 groupSham comparatorthe 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.

  1. Percentage of patients needed additional doses of morphine

    number of patients requiring additional doses of morphine

    Measured: 24 hours postoperative

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted4 May 2021
  2. Study start27 May 2021
  3. Primary completion31 Jul 2021
  4. Study completion18 Aug 2021

Resources

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)
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

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.

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