Pre-emptiveNCT05044858
Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Thoracotomy Incisions
A study testing Midpoint transverse process block group in people with Pre-emptive and Postoperative Pain, run by Tanta University at 1 site in Egypt.
Trial summary
This study is designed to investigate the analgesic efficacy of pre-emptive ultrasound-guided midpoint transverse process to pleura (MTP) block for posterolateral thoracotomy in cardiothoracic surgeries. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Pre-emptive, Postoperative Pain, Thoracotomy
- What is being tested?
- Midpoint transverse process block group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2021to 20 Sep 2022
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21- and65 years old
- American Society of Anesthesiologists (ASA) II-III
- Scheduled for posterolateral thoracotomy operation under general anesthesia
Who cannot join
- Patients with bleeding disorders,
- Mental or cognitive dysfunction
- History of chronic analgesic or drug abuse
- Allergy to local anesthetics
- Local infection at site of block
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Tanta University
Tanta, Elgarbia, 31527
Heba A. Mohamed, M.B.B.CH, +20 111 505 4431, Heba154537_pg@med.tanta.edu.eg
About this study
Official title: Analgesic Efficacy of Pre-emptive Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Patients Undergoing Posterolateral Thoracotomy Incisions: Randomized Controlled Trial
This study is designed to investigate the analgesic efficacy of pre-emptive ultrasound-guided midpoint transverse process to pleura (MTP) block for posterolateral thoracotomy in cardiothoracic surgeries.
Read the detailed description
Preemptive preoperative analgesia was first proposed, over the years it has been gradually regarded as an intervention given before incision, facilitating mobilization and functional rehabilitation after surgery, reducing postoperative opioid consumption, decreasing the incidence of adverse events and improving patient satisfaction.
The Mid Transverse Process to Pleura block, described by Costach et al. involves deposition of drug midway between the transverse process and pleura. Costach et al. postulated that the local anesthetic deposited at this point may reach the paravertebral space through several possible mechanisms, such as spread medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane
- Conditions
- Pre-emptive, Postoperative Pain, Thoracotomy
- Being tested
- Midpoint transverse process block group, Sham group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midpoint transverse process block groupProcedure or surgery
After marking the level of the incision by surgeon (commonly T5- T6) The patient will be situated in the lateral position, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally 3 cm lateral to the spinous process at the level of skin incision. 100-mm short bevel echogenic needle (Contiplex, B.Braun, Germany) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura titrated bolus of 20 ml of 0.25% bupivacaine and dexamethazone 8 mg will be injected at the target site. At end of the surgery general anaesthesia will be stopped with reversal of muscle relaxation and awakening of patient
Sham groupProcedure or surgery
General anesthesia will be induced with the same protocol and MTP block will be done but with injection of placebo (2 ml normal saline) instead of local anesthetic .
On arrival to the PACU postoperative Numerical Rating scale at rest and coughing will be recorded, analgesia will be maintained with intravenous paracetamol 1 g every 8 h and required additional rescue analgesia (morphine) at any time will be calculated.
| Study group | Role | What they receive |
|---|---|---|
| Midpoint transverse process block group | Experimental | Patients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision Receives: Procedure: Midpoint transverse process block group |
| Sham group | Sham comparator | Patients will receive general anesthesia and the same intervention steps will be performed i.e., the block under investigation but instead of local anesthetic a placebo (2ml normal saline) will be injected (sham block) Receives: Procedure: Sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of Postoperative Pain
Postoperative pain will be assessed by the Numerical Rating Scale (NRS;0 no pain while 10 is the maximum pain) at 0,4,8,12,18, 24 hours during rest and cough. If the (NRS) is 4 or more, morphine 3mg will be titrated until pain relief is achieved using a short interval between boluses
Measured: 24 hours postoperative
Secondary outcomes (3)
The amount of Postoperative morphine consumption
Total morphine consumption at 24 hours after surgery
Measured: 24 hours Postoperative
Time to the first rescue analgesia request
Time till administration of first rescue analgesia
Measured: 24 hours Postoperative
SpO2/FiO2 ratio
SpO2/FiO2 ratio at 6,8,12 and 24h postoperatively
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 posted16 Sep 2021
- Study start24 Sep 2021
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-emptiveStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Abdelhamid Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044858
- Sponsor's protocol ID
- 34646/4/21
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Pre-emptive Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Patients Undergoing Posterolateral Thoracotomy Incisions: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05044858
- Acronym / sponsor ID
- 34646/4/21
- Conditions
- Pre-emptive, Postoperative Pain, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 16 Sep 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.
This study is designed to investigate the analgesic efficacy of pre-emptive ultrasound-guided midpoint transverse process to pleura (MTP) block for posterolateral thoracotomy in cardiothoracic surgeries.
Detailed description
Preemptive preoperative analgesia was first proposed, over the years it has been gradually regarded as an intervention given before incision, facilitating mobilization and functional rehabilitation after surgery, reducing postoperative opioid consumption, decreasing the incidence of adverse events and improving patient satisfaction.
The Mid Transverse Process to Pleura block, described by Costach et al. involves deposition of drug midway between the transverse process and pleura. Costach et al. postulated that the local anesthetic deposited at this point may reach the paravertebral space through several possible mechanisms, such as spread medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midpoint transverse process block group | Experimental | Procedure: Midpoint transverse process block groupPatients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision |
| Sham group | Sham comparator | Procedure: Sham groupPatients will receive general anesthesia and the same intervention steps will be performed i.e., the block under investigation but instead of local anesthetic a placebo (2ml normal saline) will be injected (sham block) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 21- and65 years old
- American Society of Anesthesiologists (ASA) II-III
- Scheduled for posterolateral thoracotomy operation under general anesthesia
Key exclusion criteria (5 listed)
- Patients with bleeding disorders,
- Mental or cognitive dysfunction
- History of chronic analgesic or drug abuse
- Allergy to local anesthetics
- Local infection at site of block
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 |
|---|---|---|
| Midpoint transverse process block groupAfter marking the level of the incision by surgeon (commonly T5- T6) The patient will be situated in the lateral position, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally 3 cm lateral to the spinous process at the level of skin incision. 100-mm short bevel echogenic needle (Contiplex, B.Braun, Germany) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura titrated bolus of 20 ml of 0.25% bupivacaine and dexamethazone 8 mg will be injected at the target site. At end of the surgery general anaesthesia will be stopped with reversal of muscle relaxation and awakening of patient | Procedure or surgery | Midpoint transverse process block group |
| Sham groupGeneral anesthesia will be induced with the same protocol and MTP block will be done but with injection of placebo (2 ml normal saline) instead of local anesthetic . On arrival to the PACU postoperative Numerical Rating scale at rest and coughing will be recorded, analgesia will be maintained with intravenous paracetamol 1 g every 8 h and required additional rescue analgesia (morphine) at any time will be calculated. | Procedure or surgery | Sham group |
Primary outcome
The degree of Postoperative Pain
Time frame: 24 hours postoperative
Postoperative pain will be assessed by the Numerical Rating Scale (NRS;0 no pain while 10 is the maximum pain) at 0,4,8,12,18, 24 hours during rest and cough. If the (NRS) is 4 or more, morphine 3mg will be titrated until pain relief is achieved using a short interval between boluses
3 secondary outcomes
The amount of Postoperative morphine consumption
Time frame: 24 hours Postoperative
Time to the first rescue analgesia request
Time frame: 24 hours Postoperative
SpO2/FiO2 ratio
Time frame: 24 hours Postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
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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 Midpoint transverse process block group in people with Pre-emptive and Postoperative Pain, run by Tanta 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 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 1 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba A. Mohamed, M.B.B.CH (+20 111 505 4431, Heba154537_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of Postoperative Pain (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 1 Oct 2021.