Postoperative Acute PainNCT07126483
Thoracic Paravertebral Block vs Intrathecal Morphine in VATS
A study testing Thoracic paravertebral block and Morphine in people with Postoperative Acute Pain and Video-Assisted Thoracoscopic Surgery, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to find out which pain relief method works better for people having video-assisted thoracoscopic surgery. We will compare two techniques: thoracic paravertebral block (TPVB), a numbing injection near the spine, and intrathecal morphine (ITM), a small dose of morphine injected into the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Acute Pain, Video-Assisted Thoracoscopic Surgery, Intrathechal Morphine
- What is being tested?
- Thoracic paravertebral block and Morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 1 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective video-assisted thoracoscopic surgery (VATS) for wedge resection, segmentectomy, or lobectomy
- Ability to understand the study protocol and provide written informed consent
Who cannot join
- Refusal to participate
- Pregnancy
- Morbid obesity (body mass index > 30)
- Known allergy to opioids, local anesthetics, or NSAIDs
- History of neuropsychiatric disorder, cognitive impairment, or inability to communicate with investigators
- History of substance abuse
Show all 14Show fewer
- Current anticoagulant use or known bleeding disorder
- Presence of systemic infection
- Significant cardiovascular, hepatic, renal, or endocrine disease
- History of chronic pain syndromes or chronic pain treatment
- Emergency surgery or previous ipsilateral VATS or thoracotomy
- Preoperative chronic opioid therapy within 3 months (≥15 mg/day for ≥30 days)
- Severe intraoperative or postoperative bleeding, hemodynamic instability
- Requirement for prolonged postoperative ventilation (> 18 hours)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Anesthesiology, Faculty of Medicine, Ondokuz Mayis University
Samsun, Atakum, 55139
About this study
Official title: A Randomized Controlled Non-Inferiority Trial Comparing Thoracic Paravertebral Block and Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Video-Assisted Thoracoscopic Surgery
The purpose of this study is to find out which pain relief method works better for people having video-assisted thoracoscopic surgery. We will compare two techniques: thoracic paravertebral block (TPVB), a numbing injection near the spine, and intrathecal morphine (ITM), a small dose of morphine injected into the spinal fluid. We want to see if ITM works as well as TPVB in reducing the need for pain medicine during the first 24 hours after surgery. People in the study will get either TPVB or ITM before going to sleep for surgery, use a patient-controlled pain pump after surgery, and have their pain scores, medicine use, recovery, and possible side effects checked for up to 30 days after surgery.
Read the detailed description
This study will compare two different pain control techniques for people having video-assisted thoracoscopic surgery (VATS), a minimally invasive chest operation. The first technique, called thoracic paravertebral block (TPVB), involves injecting numbing medicine near the spine to block pain from the surgical area. The second technique, intrathecal morphine (ITM), involves giving a small dose of morphine into the spinal fluid to provide pain relief after surgery.
The main goal is to find out if ITM works as well as TPVB in reducing the need for additional pain medicine during the first 24 hours after surgery. This is a randomized controlled trial, meaning participants will be randomly assigned to one of the two groups. Everyone will receive general anesthesia for their surgery and will use a patient-controlled analgesia pump afterwards, along with regular pain medicines such as paracetamol and tenoxicam.
Pain scores, the amount of pain medicine used, and recovery quality will be measured at regular times in the first 24 hours after surgery. We will also monitor side effects such as nausea, vomiting, itching, or breathing problems. All patients will be followed for 30 days after surgery to check for any complications.
- Conditions
- Postoperative Acute Pain, Video-Assisted Thoracoscopic Surgery, Intrathechal Morphine, Paravertebral Peripheral Nerve Block
- Being tested
- Thoracic paravertebral block, Morphine
- Keywords
- Thoracic Paravertebral Block, Intrathecal Morphine;, Video-Assisted Thoracoscopic Surgery, Postoperative Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral blockProcedure or surgery
Also called TPVB
Ultrasound-guided single-injection thoracic paravertebral block using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000) before induction of standardized general anesthesia. Postoperative analgesia will be provided with intravenous patient-controlled analgesia morphine, along with scheduled paracetamol and NSAIDs.
MorphineDrug
Also called Intrathecal Morphine (ITM)
Single intrathecal injection of morphine (5 mcg/kg diluted in 3 mL 0.9% saline) at the L3-L4 or L4-L5 interspace before induction of standardized general anesthesia. Postoperative analgesia will be provided with intravenous patient-controlled analgesia morphine, along with scheduled paracetamol and NSAIDs.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Paravertebral Block (TPVB) | Experimental | Patients in this group will receive a single-injection ultrasound-guided thoracic paravertebral block before induction of standardized general anesthesia. The block will be performed using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000). Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs. Receives: Procedure: Thoracic paravertebral block |
| Intrathecal Morphine (ITM) | Experimental | Patients in this group will receive a single dose of intrathecal morphine (5 mcg/kg diluted in 3 mL 0.9% saline) at the L3-L4 or L4-L5 interspace before induction of standardized general anesthesia. Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 24 Hours After Surgery
Total amount of intravenous morphine milligram equivalents (IV-MME) administered during the first 24 postoperative hours.
Measured: First 24 hours postoperatively
Secondary outcomes (12)
Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 12 Hours After Surgery
Total amount of IV-MME administered during the first 12 postoperative hours.
Measured: First 12 hours postoperatively
Time to First Analgesic Request
Duration from the time the patient is extubated and able to communicate after surgery to the first patient-controlled analgesia (PCA) demand for analgesia
Measured: From extubation and recovery of communication ability to first PCA demand, within 24 hours postoperatively
Numeric Rating Scale (NRS) Pain Scores at Rest
Pain intensity at rest measured using an 11-point NRS (0 = no pain, 10 = worst pain imaginable) at 0, 3, 6, 12, 18, and 24 hours postoperatively.
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Numeric Rating Scale (NRS) Pain Scores During Coughing or Deep Breathing
Pain intensity during coughing or deep breathing measured using an 11-point NRS (0 = no pain, 10 = worst pain imaginable) at 0, 3, 6, 12, 18, and 24 hours postoperatively.
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Sedation Score
Sedation Score assessed using the Ramsay Sedation Scale (1-6) at 0, 3, 6, 12, 18, and 24 hours postoperatively
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV) Score
Score of PONV, assessed using a 4-point scale (0 = none, 1 = nausea only, 2 = single episode of vomiting, 3 = multiple episodes of vomiting).
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Pruritus Score
Score of pruritus, assessed using a 4-point scale (0-3; 0 none, 1 mild/no treatment, 2 moderate/treatment, 3 severe/repeat treatment; treatment threshold ≥2)
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Rescue Analgesia Requirement
Number of participants requiring additional analgesics beyond PCA during the first 24 hours postoperatively.
Measured: First 24 hours postoperatively
Incidence of Postoperative Complications
Number of participants experiencing any postoperative complication within 30 days
Measured: First 30 postoperative days
Quality of Recovery questionnaire (QoR-15) score
Recovery quality wil be assessed with the validated Turkish QoR-15 (15 items; total 0-150, higher scores = better recovery).
Measured: Preoperative baseline (≤24 h before surgery), 24 h postoperatively, and at hospital discharge (anticipated within 3 days)
Intraoperative Remifentanil and Propofol Consumption
Total intraoperative doses of remifentanil and propofol administered by the anesthesia team will be recorded.
Measured: Intraoperative period (from induction to 240 min)
Intraoperative Hemodynamics (Heart Rate and Mean Arterial Pressure)
Heart rate and mean arterial pressure will be recorded at standard clinical intervals.
Measured: Intraoperative period (from induction to 240 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start18 Aug 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Acute PainStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz KAYA, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126483
- Sponsor's protocol ID
- ITMTPVB2025
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including baseline characteristics, intraoperative and postoperative outcome measures, and adverse events) will be shared with researchers upon reasonable request for academic purposes. Data will be available beginning 6 months after publication of the primary results and for up to 5 years. Access will be granted following approval of a written proposal and data use agreement.
Publications
Kaya C, Demirkol K, Sener EB, Kocamanoglu IS, Elsharkawy H. Comparison of intrathecal morphine versus thoracic paravertebral block for video-assisted thoracoscopic surgery: a randomized non-inferiority trial. Reg Anesth Pain Med. 2026 Jun 17:rapm-2026-107927. doi: 10.1136/rapm-2026-107927. Online ahead of print.
PubMed 42309548
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Non-Inferiority Trial Comparing Thoracic Paravertebral Block and Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT07126483
- Acronym / sponsor ID
- ITMTPVB2025
- Conditions
- Postoperative Acute Pain, Video-Assisted Thoracoscopic Surgery, Intrathechal Morphine, Paravertebral Peripheral Nerve Block
- Keywords
- Thoracic Paravertebral Block, Intrathecal Morphine;, Video-Assisted Thoracoscopic Surgery, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 17 Aug 2025 (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 purpose of this study is to find out which pain relief method works better for people having video-assisted thoracoscopic surgery. We will compare two techniques: thoracic paravertebral block (TPVB), a numbing injection near the spine, and intrathecal morphine (ITM), a small dose of morphine injected into the spinal fluid. We want to see if ITM works as well as TPVB in reducing the need for pain medicine during the first 24 hours after surgery. People in the study will get either TPVB or ITM before going to sleep for surgery, use a patient-controlled pain pump after surgery, and have their pain scores, medicine use, recovery, and possible side effects checked for up to 30 days after surgery.
Detailed description
This study will compare two different pain control techniques for people having video-assisted thoracoscopic surgery (VATS), a minimally invasive chest operation. The first technique, called thoracic paravertebral block (TPVB), involves injecting numbing medicine near the spine to block pain from the surgical area. The second technique, intrathecal morphine (ITM), involves giving a small dose of morphine into the spinal fluid to provide pain relief after surgery.
The main goal is to find out if ITM works as well as TPVB in reducing the need for additional pain medicine during the first 24 hours after surgery. This is a randomized controlled trial, meaning participants will be randomly assigned to one of the two groups. Everyone will receive general anesthesia for their surgery and will use a patient-controlled analgesia pump afterwards, along with regular pain medicines such as paracetamol and tenoxicam.
Pain scores, the amount of pain medicine used, and recovery quality will be measured at regular times in the first 24 hours after surgery. We will also monitor side effects such as nausea, vomiting, itching, or breathing problems. All patients will be followed for 30 days after surgery to check for any complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Paravertebral Block (TPVB) | Experimental | Procedure: Thoracic paravertebral blockPatients in this group will receive a single-injection ultrasound-guided thoracic paravertebral block before induction of standardized general anesthesia. The block will be performed using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000). Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs. |
| Intrathecal Morphine (ITM) | Experimental | Drug: MorphinePatients in this group will receive a single dose of intrathecal morphine (5 mcg/kg diluted in 3 mL 0.9% saline) at the L3-L4 or L4-L5 interspace before induction of standardized general anesthesia. Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs. |
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 between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective video-assisted thoracoscopic surgery (VATS) for wedge resection, segmentectomy, or lobectomy
- Ability to understand the study protocol and provide written informed consent
Key exclusion criteria (14 listed)
- Refusal to participate
- Pregnancy
- Morbid obesity (body mass index > 30)
- Known allergy to opioids, local anesthetics, or NSAIDs
- History of neuropsychiatric disorder, cognitive impairment, or inability to communicate with investigators
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 |
|---|---|---|
| Thoracic paravertebral blockAlso: TPVBUltrasound-guided single-injection thoracic paravertebral block using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000) before induction of standardized general anesthesia. Postoperative analgesia will be provided with intravenous patient-controlled analgesia morphine, along with scheduled paracetamol and NSAIDs. | Procedure or surgery | Thoracic Paravertebral Block (TPVB) |
| MorphineAlso: Intrathecal Morphine (ITM)Single intrathecal injection of morphine (5 mcg/kg diluted in 3 mL 0.9% saline) at the L3-L4 or L4-L5 interspace before induction of standardized general anesthesia. Postoperative analgesia will be provided with intravenous patient-controlled analgesia morphine, along with scheduled paracetamol and NSAIDs. | Drug | Intrathecal Morphine (ITM) |
Primary outcome
Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 24 Hours After Surgery
Time frame: First 24 hours postoperatively
Total amount of intravenous morphine milligram equivalents (IV-MME) administered during the first 24 postoperative hours.
12 secondary outcomes
Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 12 Hours After Surgery
Time frame: First 12 hours postoperatively
Time to First Analgesic Request
Time frame: From extubation and recovery of communication ability to first PCA demand, within 24 hours postoperatively
Numeric Rating Scale (NRS) Pain Scores at Rest
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Numeric Rating Scale (NRS) Pain Scores During Coughing or Deep Breathing
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Sedation Score
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV) Score
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Pruritus Score
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Rescue Analgesia Requirement
Time frame: First 24 hours postoperatively
Incidence of Postoperative Complications
Time frame: First 30 postoperative days
Quality of Recovery questionnaire (QoR-15) score
Time frame: Preoperative baseline (≤24 h before surgery), 24 h postoperatively, and at hospital discharge (anticipated within 3 days)
Intraoperative Remifentanil and Propofol Consumption
Time frame: Intraoperative period (from induction to 240 min)
Intraoperative Hemodynamics (Heart Rate and Mean Arterial Pressure)
Time frame: Intraoperative period (from induction to 240 min)
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 Jan 2026.
- Derived from this study: PubMed 42309548Kaya C, Demirkol K, Sener EB, Kocamanoglu IS, Elsharkawy H. Comparison of intrathecal morphine versus thoracic paravertebral block for video-assisted thoracoscopic surgery: a randomized non-inferiority trial. Reg Anesth Pain Med. 2026 Jun 17:rapm-2026-107927. doi: 10.1136/rapm-2026-107927. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including baseline characteristics, intraoperative and postoperative outcome measures, and adverse events) will be shared with researchers upon reasonable request for academic purposes. Data will be available beginning 6 months after publication of the primary results and for up to 5 years. Access will be granted following approval of a written proposal and data use agreement.
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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 Thoracic paravertebral block and Morphine in people with Postoperative Acute Pain and Video-Assisted Thoracoscopic Surgery, run by Ondokuz Mayıs University 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 4 inclusion and 14 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 Jan 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. 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?
Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 24 Hours After Surgery (time frame: First 24 hours postoperatively). 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 NCT07126483, which also lists 1 linked publication.
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 Jan 2026.