Postoperative PainNCT04443556
Effect of Continue RISS Block in Thoracotomy
A study testing Tramadol and IV PCA in people with Postoperative Pain and Thoracotomy, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Thoracotomy is one of the most painful surgery. Acute postoperative pain increases postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic pain syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Thoracotomy
- What is being tested?
- Tramadol and IV PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2020to 15 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age undergoing elective thoracic surgery
- American Society of Anesthesiologists (ASA) physical status I-III grade
Who cannot join
- Patient refusal
- History of psychiatric and cognitive disorders.
- Patients allergic to the drugs used in the study
- Emergent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continue Rhomboid Intercostal and Subserratus Plane Block in Thorocotomy
Thoracotomy is one of the most painful surgery. Acute postoperative pain increases postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic pain syndrome. This study aimed to assess the efficacy of continuous rhomboid intercostal and subserratus plane (RISS) block by inserting a catheter under direct vision for controlling acute thoracotomy pain.
Read the detailed description
Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue RISS block. First catheter tip will be place towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be place in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours.
- Conditions
- Postoperative Pain, Thoracotomy
- Being tested
- Tramadol, IV PCA
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Also called Local anesthetic
Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue the RISS block. First catheter tip will be placed towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be placed in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours. Also an IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.
IV PCAOther
An IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Group Rhomboid Intercostal and Subserratus Plane Block | Active comparator | Standart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block Receives: Drug: Tramadol; Other: IV PCA |
| Control Group | Other | Standart postoperative analgesia Receives: Other: IV PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
Measured: postoperative 48 hour
Secondary outcomes (1)
Analgesic consumption
Total opioid consumption after the surgery
Measured: Postoperative 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start31 Aug 2020
- Primary completion30 Jan 2021
- Study completion15 Feb 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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443556
- Sponsor's protocol ID
- RISS THORACOTOMY
- Status last verified
- Apr 2021
- First submitted
- 20 Jun 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continue Rhomboid Intercostal and Subserratus Plane Block in Thorocotomy
- ClinicalTrials.gov ID
- NCT04443556
- Acronym / sponsor ID
- RISS THORACOTOMY
- Conditions
- Postoperative Pain, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 23 Jun 2020 (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.
Thoracotomy is one of the most painful surgery. Acute postoperative pain increases postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic pain syndrome. This study aimed to assess the efficacy of continuous rhomboid intercostal and subserratus plane (RISS) block by inserting a catheter under direct vision for controlling acute thoracotomy pain.
Detailed description
Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue RISS block. First catheter tip will be place towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be place in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Rhomboid Intercostal and Subserratus Plane Block | Active comparator | Drug: Tramadol, Other: IV PCAStandart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block |
| Control Group | Other | Other: IV PCAStandart postoperative analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age undergoing elective thoracic surgery
- American Society of Anesthesiologists (ASA) physical status I-III grade
Key exclusion criteria (4 listed)
- Patient refusal
- History of psychiatric and cognitive disorders.
- Patients allergic to the drugs used in the study
- Emergent surgery
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 |
|---|---|---|
| TramadolAlso: Local anestheticBefore the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue the RISS block. First catheter tip will be placed towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be placed in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours. Also an IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded. | Drug | Group Rhomboid Intercostal and Subserratus Plane Block |
| IV PCAAn IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded. | Other | Control Group, Group Rhomboid Intercostal and Subserratus Plane Block |
Primary outcome
postoperative pain
Time frame: postoperative 48 hour
Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
1 secondary outcome
Analgesic consumption
Time frame: Postoperative 48 hour
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 20 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tramadol and IV PCA in people with Postoperative Pain and Thoracotomy, run by Konya Meram State 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 4 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 20 Apr 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 pain (time frame: postoperative 48 hour). 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 20 Apr 2021; AzTrials last refreshed its copy on 3 Nov 2026.