Pain, PostoperativeNCT04990700
Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain
A study testing Partial rib resection in people with Pain, Postoperative and Iatrogenic Injury, run by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of partial rib resection in reducing acute post-thoracotomy pain Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Iatrogenic Injury, Post-thoracotomy Pain Syndrome
- What is being tested?
- Partial rib resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2019to 27 Nov 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who underwent thoracotomy in our clinic in 2019-2020
- Participants signing an informed consent form
Who cannot join
- Thoracic wall tumor
- Invasion of the thoracic wall by extrathoracic malignancy
- Pleural pathology
- History of previous rib fracture
- History of previous thoracotomy
- History of thoracic radiotherapy
- Emergency surgery
- Simultaneous incisions other than thoracotomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, 34668
About this study
Official title: Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain: A Randomized Prospective Study
The aim of this study is to evaluate the effect of partial rib resection in reducing acute post-thoracotomy pain
Read the detailed description
It is known that severe post thoracotomy pain can be reduced by half with some strategies to prevent pain development. It was thought that partial rib resection would reduce intercostal tension and prevent an uncontrolled fracture. Thus, it is argued that post thoracotomy pain can be reduced. Partial rib resection is applied in clinical practice in selected patient groups. However, we could not find a clinical study on this subject in the English literature. The aim of this study is to determine whether partial rib resection has an effect on the control of thoracotomy pain.
Before the thoracotomy incision, simple randomization will be performed by flipping a coin.
Routine thoracotomy incision will be performed in the control group. In the intervention group, approximately 1 cm segment of the 6th rib will be excised with a rib scissors before the thorax retractor was placed.
Pericostal suture technique will be used in both groups at thoracotomy closure. Demographic information of the cases, preoperative respiratory function parameters, body mass index, Visual Analogue Scale scores, complications and analgesic doses will be recorded in the Case Report Form regularly.
- Being tested
- Partial rib resection
- Keywords
- Post thoracotomy pain, Iatrogenic rib fracture, Thoracotomy, Partial rib resection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial rib resectionProcedure or surgery
1 cm partial rib resection during thoracotomy opening
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Includes patients undergoing routine thoracotomy |
| Intervention Group | Experimental | The group that will undergo 1 cm partial rib resection during thoracotomy. Receives: Procedure: Partial rib resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative visual analog scale scores
Min:1, Max:10 points, Higher scores mean worse outcome
Measured: 7 days
Secondary outcomes (5)
Iatrogenic rib fractures
Yes or no
Measured: During operation
Administered analgesic doses
Milligram
Measured: Up to 4 weeks
Duration of drainage
Days
Measured: Up to 4 weeks
Length of hospital stay
Days
Measured: Up to 4 weeks
Number of participants with postoperative bronchopulmonary complications
Yes or no
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start9 May 2019
- Primary completion27 Oct 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinical data of intervention group and control groups will be compared
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail Dal, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Investigators
- İsmail Dal, PhD, Principal investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990700
- Sponsor's protocol ID
- SiyamiErsek
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
PubMed 18456219Meyers JR, Lembeck L, O'Kane H, Baue AE. Changes in functional residual capacity of the lung after operation. Arch Surg. 1975 May;110(5):576-83. doi: 10.1001/archsurg.1975.01360110122020.
PubMed 1093513Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.
PubMed 8722735Soto RG, Fu ES. Acute pain management for patients undergoing thoracotomy. Ann Thorac Surg. 2003 Apr;75(4):1349-57. doi: 10.1016/s0003-4975(02)04647-7.
PubMed 12683601Wu N, Yan S, Wang X, Lv C, Wang J, Zheng Q, Feng Y, Yang Y. A prospective, single-blind randomised study on the effect of intercostal nerve protection on early post-thoracotomy pain relief. Eur J Cardiothorac Surg. 2010 Apr;37(4):840-5. doi: 10.1016/j.ejcts.2009.11.004. Epub 2009 Dec 1.
PubMed 19954996El-Hag-Aly MA, Hagag MG, Allam HK. If post-thoracotomy pain is the target, Integrated Thoracotomy is the choice. Gen Thorac Cardiovasc Surg. 2019 Nov;67(11):955-961. doi: 10.1007/s11748-019-01126-2. Epub 2019 Apr 16.
PubMed 30993532
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04990700
- Acronym / sponsor ID
- SiyamiErsek
- Keywords
- Post thoracotomy pain, Iatrogenic rib fracture, Thoracotomy, Partial rib resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 4 Aug 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.
The aim of this study is to evaluate the effect of partial rib resection in reducing acute post-thoracotomy pain
Detailed description
It is known that severe post thoracotomy pain can be reduced by half with some strategies to prevent pain development. It was thought that partial rib resection would reduce intercostal tension and prevent an uncontrolled fracture. Thus, it is argued that post thoracotomy pain can be reduced. Partial rib resection is applied in clinical practice in selected patient groups. However, we could not find a clinical study on this subject in the English literature. The aim of this study is to determine whether partial rib resection has an effect on the control of thoracotomy pain.
Before the thoracotomy incision, simple randomization will be performed by flipping a coin.
Routine thoracotomy incision will be performed in the control group. In the intervention group, approximately 1 cm segment of the 6th rib will be excised with a rib scissors before the thorax retractor was placed.
Pericostal suture technique will be used in both groups at thoracotomy closure. Demographic information of the cases, preoperative respiratory function parameters, body mass index, Visual Analogue Scale scores, complications and analgesic doses will be recorded in the Case Report Form regularly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clinical data of intervention group and control groups will be compared
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Includes patients undergoing routine thoracotomy |
| Intervention Group | Experimental | Procedure: Partial rib resectionThe group that will undergo 1 cm partial rib resection during thoracotomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who underwent thoracotomy in our clinic in 2019-2020
- Participants signing an informed consent form
Key exclusion criteria (8 listed)
- Thoracic wall tumor
- Invasion of the thoracic wall by extrathoracic malignancy
- Pleural pathology
- History of previous rib fracture
- History of previous thoracotomy
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 |
|---|---|---|
| Partial rib resection1 cm partial rib resection during thoracotomy opening | Procedure or surgery | Intervention Group |
Primary outcome
Postoperative visual analog scale scores
Time frame: 7 days
Min:1, Max:10 points, Higher scores mean worse outcome
5 secondary outcomes
Iatrogenic rib fractures
Time frame: During operation
Administered analgesic doses
Time frame: Up to 4 weeks
Duration of drainage
Time frame: Up to 4 weeks
Length of hospital stay
Time frame: Up to 4 weeks
Number of participants with postoperative bronchopulmonary complications
Time frame: Up to 4 weeks
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 4 Aug 2021.
- Background: PubMed 18456219Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
- Background: PubMed 1093513Meyers JR, Lembeck L, O'Kane H, Baue AE. Changes in functional residual capacity of the lung after operation. Arch Surg. 1975 May;110(5):576-83. doi: 10.1001/archsurg.1975.01360110122020.
- Background: PubMed 8722735Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.
- Background: PubMed 12683601Soto RG, Fu ES. Acute pain management for patients undergoing thoracotomy. Ann Thorac Surg. 2003 Apr;75(4):1349-57. doi: 10.1016/s0003-4975(02)04647-7.
- Background: PubMed 19954996Wu N, Yan S, Wang X, Lv C, Wang J, Zheng Q, Feng Y, Yang Y. A prospective, single-blind randomised study on the effect of intercostal nerve protection on early post-thoracotomy pain relief. Eur J Cardiothorac Surg. 2010 Apr;37(4):840-5. doi: 10.1016/j.ejcts.2009.11.004. Epub 2009 Dec 1.
- Background: PubMed 30993532El-Hag-Aly MA, Hagag MG, Allam HK. If post-thoracotomy pain is the target, Integrated Thoracotomy is the choice. Gen Thorac Cardiovasc Surg. 2019 Nov;67(11):955-961. doi: 10.1007/s11748-019-01126-2. Epub 2019 Apr 16.
- Individual participant dataSharing planned: No
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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.
İsmail Dal, PhD principal investigator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial rib resection in people with Pain, Postoperative and Iatrogenic Injury, run by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital 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 8 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 4 Aug 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 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. 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?
Postoperative visual analog scale scores (time frame: 7 days). 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 NCT04990700, which also lists 6 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 4 Aug 2021.