Pain Mangement of ThoracotomyNCT06301334
Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy
A study testing Bupivacaine 0.25% Injectable Solution in people with Pain Mangement of Thoracotomy, run by Sohag University.
Trial summary
A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications Though epidural… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Mangement of Thoracotomy
- What is being tested?
- Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age from 18 to 75 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II-III.
- Patient undergoing unilateral thoracotomy surgery.
Who cannot join
- • BMI more than 30 kg/m2.
- Patients who are taking analgesics for chronic illness or have a history of substance abuse.
- Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
- Patients with a history of coagulopathy.
- Severe heart diseases.
- Hepatic or renal insufficiency.
- Infection at the site of infiltration
Trial locations and contacts
No sites are listed yet.
wesam A Abo Elwafa Sallam, Assistant professor contact
About this study
Official title: Block and Erector Comparative Study Between Costotransverse Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Thoracotomy
A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications
Though epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy
- Conditions
- Pain Mangement of Thoracotomy
- Being tested
- Bupivacaine 0.25% Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25% Injectable SolutionDrug
Group CTB (n=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25% Group ESPB (n=30): patients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Group CTB | Active comparator | n=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25% Receives: Drug: Bupivacaine 0.25% Injectable Solution |
| Group ESPB | Active comparator | patients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25% Receives: Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy.
study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomyA standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If visual analogue scale (VAS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia If visual analogue scale (VAS) is more than 5
Measured: 5months
Secondary outcomes (1)
The secondary outcome is the total postoperative morphine consumption, time of first analgesic,
The secondary outcome is the total postoperative morphine consumption, time of first analgesic A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If visual analogue scale (VAS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia If visual analogue scale (VAS) is more than 5
Measured: 5months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain Mangement of ThoracotomyStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mokhtar Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301334
- Sponsor's protocol ID
- Soh-Med-24-01-11MS
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mijatovic D, Bhalla T, Farid I. Post-thoracotomy analgesia. Saudi J Anaesth. 2021 Jul-Sep;15(3):341-347. doi: 10.4103/sja.SJA_743_20. Epub 2021 Jun 19.
PubMed 34764841Liu Y, Xiao S, Yang H, Lv X, Hou A, Ma Y, Jiang Y, Duan C, Mi W; CAPOPS Group. Postoperative pain-related outcomes and perioperative pain management in China: a population-based study. Lancet Reg Health West Pac. 2023 Jun 10;39:100822. doi: 10.1016/j.lanwpc.2023.100822. eCollection 2023 Oct.
PubMed 37927993Singariya G, Kamal M, Paliwal B. Pain after thoracotomy: Conquered or to be conquered? Indian J Anaesth. 2023 Feb;67(Suppl 1):S12-S14. doi: 10.4103/ija.ija_90_23. Epub 2023 Feb 10. No abstract available.
PubMed 37065951Huang W, Wang W, Xie W, Chen Z, Liu Y. Erector spinae plane block for postoperative analgesia in breast and thoracic surgery: A systematic review and meta-analysis. J Clin Anesth. 2020 Nov;66:109900. doi: 10.1016/j.jclinane.2020.109900. Epub 2020 Jun 2.
PubMed 32502778
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Block and Erector Comparative Study Between Costotransverse Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT06301334
- Acronym / sponsor ID
- Soh-Med-24-01-11MS
- Conditions
- Pain Mangement of Thoracotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 8 Mar 2024 (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.
A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications
Though epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CTB | Active comparator | Drug: Bupivacaine 0.25% Injectable Solutionn=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25% |
| Group ESPB | Active comparator | Drug: Bupivacaine 0.25% Injectable Solutionpatients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age from 18 to 75 years old.
Key exclusion criteria (7 listed)
- • BMI more than 30 kg/m2.
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 |
|---|---|---|
| Bupivacaine 0.25% Injectable SolutionGroup CTB (n=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25% Group ESPB (n=30): patients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25% | Drug | Group CTB, Group ESPB |
Primary outcome
study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy.
Time frame: 5months
study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomyA standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If visual analogue scale (VAS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia If visual analogue scale (VAS) is more than 5
1 secondary outcome
The secondary outcome is the total postoperative morphine consumption, time of first analgesic,
Time frame: 5months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 34764841Mijatovic D, Bhalla T, Farid I. Post-thoracotomy analgesia. Saudi J Anaesth. 2021 Jul-Sep;15(3):341-347. doi: 10.4103/sja.SJA_743_20. Epub 2021 Jun 19.
- Background: PubMed 37927993Liu Y, Xiao S, Yang H, Lv X, Hou A, Ma Y, Jiang Y, Duan C, Mi W; CAPOPS Group. Postoperative pain-related outcomes and perioperative pain management in China: a population-based study. Lancet Reg Health West Pac. 2023 Jun 10;39:100822. doi: 10.1016/j.lanwpc.2023.100822. eCollection 2023 Oct.
- Background: PubMed 37065951Singariya G, Kamal M, Paliwal B. Pain after thoracotomy: Conquered or to be conquered? Indian J Anaesth. 2023 Feb;67(Suppl 1):S12-S14. doi: 10.4103/ija.ija_90_23. Epub 2023 Feb 10. No abstract available.
- Background: PubMed 32502778Huang W, Wang W, Xie W, Chen Z, Liu Y. Erector spinae plane block for postoperative analgesia in breast and thoracic surgery: A systematic review and meta-analysis. J Clin Anesth. 2020 Nov;66:109900. doi: 10.1016/j.jclinane.2020.109900. Epub 2020 Jun 2.
- Individual participant dataSharing planned: Undecided
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.
wesam A Abo Elwafa Sallam, Assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.25% Injectable Solution in people with Pain Mangement of Thoracotomy, run by Sohag University.
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 4 inclusion and 7 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 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 ahmed M mokhar, Resident (01121695985, ahmedmokhtar@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy. (time frame: 5months). 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 NCT06301334, which also lists 4 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 8 Mar 2024.