Acute Postoperative PainNCT07335250
Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy
A study testing Intertransverse Process Block in people with Acute Postoperative Pain and Thoracotomy Surgery, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, triple-blind, placebo-controlled clinical trial will investigate the effectiveness of the intertransverse process block (ITPB) for postoperative analgesia in patients undergoing elective thoracotomy with unilateral lobectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Postoperative Pain, Thoracotomy Surgery, Intertransverse Process Block
- What is being tested?
- Intertransverse Process Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2026to 7 Sep 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Age between 18 and 85 years
- ASA Physical Status classification I-III
- Elective thoracotomy with planned unilateral lobectomy
- Anticipated hospital stay of at least one night
- Expected requirement for parenteral opioid analgesia for at least 24 hours postoperatively
- Ability to operate an intravenous patient-controlled analgesia (PCA) device
Who cannot join
- Patients undergoing emergency surgery
- Presence of infection or open wound at the injection site
- Coagulopathy
- Hepatic or renal failure
- Patients undergoing reoperation
- Patients with missing or incomplete data
Show all 11Show fewer
- Pregnancy or lactation
- Tracheal malformation or tracheostomy
- Chronic opioid use (≥30 days within the last 3 months, ≥15 mg/day morphine equivalent)
- Patients exceeding the maximum safe local anesthetic dose based on weight (2.5 mg/kg, max 150 mg)
- Patients who refuse data privacy consent will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain Control With Intertransverse Process Block in Patients Undergoing Thoracotomy With Lobectomy
This prospective, randomized, triple-blind, placebo-controlled clinical trial will investigate the effectiveness of the intertransverse process block (ITPB) for postoperative analgesia in patients undergoing elective thoracotomy with unilateral lobectomy. The study will be conducted at a single tertiary center in accordance with the principles of the Declaration of Helsinki, and written informed consent will be obtained from all participants.
Patients will be randomized in a 1:1 ratio to receive either ultrasound-guided ITPB with 0.5% bupivacaine or placebo (normal saline) prepared in identical syringes to ensure allocation concealment. The block will be performed by an experienced anesthesiologist immediately after surgery and before emergence from anesthesia. Both groups will receive standardized general anesthesia, multimodal perioperative analgesia, and postoperative intravenous morphine patient-controlled analgesia (PCA).
The trial aims to evaluate the analgesic efficacy and opioid-sparing effect of ITPB while maintaining safety and adherence to routine clinical practice. Outcomes will include postoperative pain scores, opioid consumption, rescue analgesia requirement, and adverse events.
- Being tested
- Intertransverse Process Block, Placebo
- Keywords
- Intertransverse Process Block, Thoracotomy Lobectomy, Acute Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intertransverse Process BlockProcedure or surgery
The block will be performed under ultrasound guidance by the same anesthesiologist with more than five years of experience, immediately after surgery and before emergence from anesthesia. Patients will be placed in the lateral decubitus position with the operative side uppermost and the skin prepared.
Using a high-frequency linear probe (Mindray DC-60 Exp), the T5 spinous process will be identified at the midline, then the probe will be moved approximately 2 cm laterally to visualize the superior costotransverse ligament (SCTL) and pleura. The needle will be advanced in-plane in a caudal-to-cranial direction toward the cranial border of the fourth rib. After confirmation of correct spread by hydrodissection, 20 mL of 0.5% bupivacaine will be injected.
PlaceboProcedure or surgery
In the control group, the same procedure will be conducted, but saline will be injected instead of local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Block Group - Intertransverse Process Block | Active comparator | Not described Receives: Procedure: Intertransverse Process Block |
| Control Group - Placebo: | Placebo comparator | Not described Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption Within the First 24 Hours After Surgery
The primary objective of the study is to evaluate the effect of the intertransverse process block (ITPB) on opioid consumption within the first 24 hours postoperatively in patients undergoing thoracotomy with unilateral lobectomy. Morphine consumption will be determined based on patient-controlled analgesia (PCA) use.
Measured: 24 hours postoperatively
Secondary outcomes (1)
NRS score
After extubation, patients will be assessed at 0, 6, 12, and 24 hours for pain intensity both at rest and during coughing using the Numeric Rating Scale (NRS; 0-10).
The Numeric Rating Scale ranges from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating worse pain severity.
Measured: 0 to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start8 Apr 2026
- Primary completion2 Sep 2026
- Study completion7 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups to receive either an ultrasound-guided intertransverse process block with bupivacaine or a placebo saline injection at the same site. Each participant will receive only one intervention, and postoperative outcomes will be compared between the two groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Keklicek, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335250
- Sponsor's protocol ID
- 2025/485
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control With Intertransverse Process Block in Patients Undergoing Thoracotomy With Lobectomy
- ClinicalTrials.gov ID
- NCT07335250
- Acronym / sponsor ID
- 2025/485
- Keywords
- Intertransverse Process Block, Thoracotomy Lobectomy, Acute Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 7 Sep 2026 (actual)
- First posted
- 13 Jan 2026 (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 prospective, randomized, triple-blind, placebo-controlled clinical trial will investigate the effectiveness of the intertransverse process block (ITPB) for postoperative analgesia in patients undergoing elective thoracotomy with unilateral lobectomy. The study will be conducted at a single tertiary center in accordance with the principles of the Declaration of Helsinki, and written informed consent will be obtained from all participants.
Patients will be randomized in a 1:1 ratio to receive either ultrasound-guided ITPB with 0.5% bupivacaine or placebo (normal saline) prepared in identical syringes to ensure allocation concealment. The block will be performed by an experienced anesthesiologist immediately after surgery and before emergence from anesthesia. Both groups will receive standardized general anesthesia, multimodal perioperative analgesia, and postoperative intravenous morphine patient-controlled analgesia (PCA).
The trial aims to evaluate the analgesic efficacy and opioid-sparing effect of ITPB while maintaining safety and adherence to routine clinical practice. Outcomes will include postoperative pain scores, opioid consumption, rescue analgesia requirement, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups to receive either an ultrasound-guided intertransverse process block with bupivacaine or a placebo saline injection at the same site. Each participant will receive only one intervention, and postoperative outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Block Group - Intertransverse Process Block | Active comparator | Procedure: Intertransverse Process Block |
| Control Group - Placebo: | Placebo comparator | Procedure: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of written informed consent
- Age between 18 and 85 years
- ASA Physical Status classification I-III
- Elective thoracotomy with planned unilateral lobectomy
- Anticipated hospital stay of at least one night
Key exclusion criteria (11 listed)
- Patients undergoing emergency surgery
- Presence of infection or open wound at the injection site
- Coagulopathy
- Hepatic or renal failure
- Patients undergoing reoperation
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 |
|---|---|---|
| Intertransverse Process BlockThe block will be performed under ultrasound guidance by the same anesthesiologist with more than five years of experience, immediately after surgery and before emergence from anesthesia. Patients will be placed in the lateral decubitus position with the operative side uppermost and the skin prepared. Using a high-frequency linear probe (Mindray DC-60 Exp), the T5 spinous process will be identified at the midline, then the probe will be moved approximately 2 cm laterally to visualize the superior costotransverse ligament (SCTL) and pleura. The needle will be advanced in-plane in a caudal-to-cranial direction toward the cranial border of the fourth rib. After confirmation of correct spread by hydrodissection, 20 mL of 0.5% bupivacaine will be injected. | Procedure or surgery | Block Group - Intertransverse Process Block |
| PlaceboIn the control group, the same procedure will be conducted, but saline will be injected instead of local anesthetic. | Procedure or surgery | Control Group - Placebo: |
Primary outcome
Morphine Consumption Within the First 24 Hours After Surgery
Time frame: 24 hours postoperatively
The primary objective of the study is to evaluate the effect of the intertransverse process block (ITPB) on opioid consumption within the first 24 hours postoperatively in patients undergoing thoracotomy with unilateral lobectomy. Morphine consumption will be determined based on patient-controlled analgesia (PCA) use.
1 secondary outcome
NRS score
Time frame: 0 to 24 hours postoperatively
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 9 Sep 2026.
- 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.
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 Intertransverse Process Block in people with Acute Postoperative Pain and Thoracotomy Surgery, run by Konya City 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 7 inclusion and 11 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 9 Sep 2026. 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. 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?
Morphine Consumption Within the First 24 Hours After Surgery (time frame: 24 hours postoperatively). 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 9 Sep 2026.