Postthoracotomy PainNCT07768826
Comparison of Serratus Posterior Superior Intercostal Plane Block and Paravertebral Block for Post-Thoracotomy Pain Management
A study testing Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Paravertebral Block (PVB) in people with Postthoracotomy Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing thoracic surgery via thoracotomy are required to remain in the lateral decubitus position for prolonged periods due to surgical access requirements. This positioning is considered one of the major contributors to postoperative shoulder pain, particularly because of the mechanical stress imposed on… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postthoracotomy Pain
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Paravertebral Block (PVB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 25 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo elective thoracic surgery via thoracotomy
- Patients aged between 18 and 75 years
- Patients classified as American Society of Anesthesiologists (ASA) physical status I-III
- Patients who provide written informed consent to participate in the study
Who cannot join
- Patients with a known allergy or hypersensitivity to local anesthetic agents
- Patients with coagulation disorders or those receiving anticoagulant therapy
- Pregnant or breastfeeding women
- Patients with impaired consciousness or inability to communicate effectively
- Patients in whom block administration is unsuccessful
- Patients who decline regional block administration
Show all 13Show fewer
- Patients with mental or cognitive impairment precluding reliable preoperative pain assessment
- Patients with intolerance to or contraindications for morphine or other opioid medications
- Patients who voluntarily choose to withdraw from the study at any stage of the research process
- Patients who develop intraoperative surgical complications
- Patients who experience hemodynamic complications during the perioperative period
- Patients who develop serious postoperative medical complications requiring intensive care unit admission, reoperation, or other major medical interventions
- Patients with incomplete follow-up data or in whom opioid consumption cannot be accurately assessed due to technical malfunction of the patient-controlled analgesia (PCA) device will be excluded from the final analysis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara bilkent şehir hastanesi
Ankara, Çankaya
About this study
Patients undergoing thoracic surgery via thoracotomy are required to remain in the lateral decubitus position for prolonged periods due to surgical access requirements. This positioning is considered one of the major contributors to postoperative shoulder pain, particularly because of the mechanical stress imposed on the dependent shoulder and scapulothoracic region. The resulting pain not only reduces patient comfort but may also delay early mobilization, thereby adversely affecting respiratory function and the recovery of postoperative pulmonary capacity . Therefore, in thoracic surgery, the ability of regional anesthesia techniques to provide sensory coverage extending beyond the incision site to include dermatomes associated with the shoulder girdle has emerged as a critical factor influencing analgesic efficacy.
In this context, the present study aims to comprehensively compare Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Thoracic Paravertebral Block (PVB) with respect to both the management of post-thoracotomy postoperative shoulder pain and their overall analgesic effectiveness. Furthermore, the contribution of these two techniques to postoperative pain management will be thoroughly evaluated in terms of patient comfort and safety profiles.
Read the detailed description
Thoracotomy is a commonly performed approach in thoracic surgery and is associated with severe postoperative pain due to extensive tissue dissection and rib retraction. Inadequate control of postoperative pain may lead to serious complications, including impaired respiratory function, secretion retention, atelectasis, pneumonia, chronic post-thoracotomy pain syndrome, and reduced patient satisfaction . Therefore, identifying effective, safe, and sustainable analgesic strategies following thoracotomy is of critical importance for improving both patient comfort and clinical outcomes.
Thoracic epidural analgesia (TEA) has long been considered one of the most widely used techniques for postoperative pain control in thoracic surgery. Although TEA provides effective bilateral somatic and visceral analgesia, its clinical use is limited by several factors, including hypotension, urinary retention, motor blockade, epidural hematoma, technical challenges, and the requirement for patient cooperation. Consequently, in addition to systemic analgesics, regional anesthesia techniques have become essential components of multimodal analgesia protocols in thoracic surgery . This has encouraged the development of alternative approaches that are less invasive, technically more feasible, and capable of providing comparable analgesic efficacy. Fascial plane blocks, such as paravertebral block (PVB), erector spinae plane block (ESPB), serratus anterior plane block, and serratus posterior plane blocks, have gained increasing attention because they can be performed within more superficial anatomical planes and are associated with a lower risk of complications . These techniques are particularly considered safe alternatives in patients for whom epidural analgesia is contraindicated or technically challenging .
Thoracic paravertebral block (PVB), one of the techniques evaluated in the present study, provides effective control of both somatic and visceral pain through direct blockade of the thoracic spinal nerves. Despite its relatively deep anatomical location, PVB has demonstrated efficacy in numerous clinical settings and has been widely adopted in clinical practice. It has been successfully utilized in major thoracic procedures, including open thoracotomy, video-assisted thoracoscopic surgery (VATS), breast surgery, management of rib fractures, and extensive thoracic operations such as pneumonectomy and lobectomy. However, due to its deep anatomical location, PVB is associated with technical challenges and potential complications, including pneumothorax and vascular injury .
As an alternative approach, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) has emerged as a novel regional anesthesia technique offering a technically simpler and anatomically safer profile owing to its more superficial site of administration. This block is performed by injecting local anesthetic between the serratus posterior superior muscle and the second or third intercostal muscles. Following injection, the spread of local anesthetic may extend to the dorsal rami, lateral cutaneous branches of the intercostal nerves, and the paravertebral space. Consequently, SPSIPB can provide extensive sensory blockade covering dermatomes from T2 to T9 .
The potential of SPSIPB to achieve broad dermatomal coverage and provide segmental analgesia comparable to that of PVB has been supported by cadaveric studies and case series reported in the literature. Anatomical and technical descriptions have demonstrated that the sensory distribution of SPSIPB may extend from C3 to T10 dermatomes . Such extensive spread suggests that SPSIPB may provide effective analgesia for upper thoracic regions.
The analgesic efficacy of SPSIPB has also been demonstrated in procedures involving anatomical regions similar to thoracic surgery, including video-assisted thoracoscopic surgery (VATS), reduction mammaplasty, cardiac surgery, and pectus excavatum repair, as reported in several case studies and clinical reports. However, prospective studies directly comparing SPSIPB and PVB in patients undergoing open thoracotomy remain limited.
In this context, the primary objective of the present study is to compare the efficacy of SPSIPB and PVB in providing postoperative analgesia in patients undergoing thoracic surgical procedures performed via thoracotomy and to contribute to the optimization of postoperative pain management strategies in thoracic surgery.
Patients undergoing thoracic surgery via thoracotomy are required to remain in the lateral decubitus position for prolonged periods to facilitate surgical exposure. This positioning is considered one of the major contributors to postoperative shoulder pain, primarily due to the mechanical stress imposed on the non-dependent shoulder and scapulothoracic region. The resulting pain not only compromises patient comfort but may also delay early mobilization, thereby adversely affecting respiratory function and the recovery of postoperative pulmonary capacity . Therefore, the ability of regional anesthesia techniques used in thoracic surgery to provide sensory blockade extending beyond the surgical incision site to include dermatomes associated with the shoulder girdle has emerged as an important determinant of analgesic success.
Accordingly, the present study aims to comprehensively compare SPSIPB and PVB with regard to both the management of post-thoracotomy postoperative shoulder pain and their overall analgesic efficacy. Furthermore, the contribution of these two techniques to postoperative pain management will be thoroughly evaluated in terms of patient comfort and safety profiles.
- Conditions
- Postthoracotomy Pain
- Being tested
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Paravertebral Block (PVB)
- Keywords
- Paravertebral Block, Serratus Posterior Superior Intercostal Plane Block, Thoracotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Other
In this study, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) will be performed under ultrasound guidance using an in-plane technique at the level of the superomedial border of the scapula. The block will be administered by injecting local anesthetic into the interfascial plane between the serratus posterior superior muscle and the second or third intercostal muscle. Bupivacaine at a concentration of 0.25% will be used as the local anesthetic agent. The total dose administered will be calculated according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. In routine clinical practice, an injection volume of 25-30 mL of bupivacaine is generally sufficient to achieve an effective block in most patients.
Paravertebral Block (PVB)Other
Thoracic Paravertebral Block (PVB) will be performed under ultrasound guidance using an in-plane technique at the T4-T6 thoracic vertebral levels. The needle tip will be advanced into the paravertebral space located between the transverse process and the parietal pleura.
For PVB, 0.25% bupivacaine will be used as the local anesthetic agent. The total dose will be adjusted according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. Based on evidence from the literature, an injection volume of 25-30 mL of bupivacaine generally provides adequate spread in the majority of patients.
All block procedures will be performed by an experienced anesthesiologist and a resident physician involved in the study. Following block administration, all patients will undergo general anesthesia, and thoracic surgical procedures will subsequently be performed via thoracotomy by the thoracic surgery team.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block | Experimental | In this study, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) will be performed under ultrasound guidance using an in-plane technique at the level of the superomedial border of the scapula. The block will be administered by injecting local anesthetic into the interfascial plane between the serratus posterior superior muscle and the second or third intercostal muscle. Bupivacaine at a concentration of 0.25% will be used as the local anesthetic agent. The total dose administered will be calculated according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. In routine clinical practice, an injection volume of 25-30 mL of bupivacaine is generally sufficient to achieve an effective block in most patients. Receives: Other: Serratus Posterior Superior Intercostal Plane Block (SPSIPB) |
| Paravertebral Block | Active comparator | Thoracic Paravertebral Block (PVB) will be performed under ultrasound guidance using an in-plane technique at the T4-T6 thoracic vertebral levels. The needle tip will be advanced into the paravertebral space located between the transverse process and the parietal pleura.
For PVB, 0.25% bupivacaine will be used as the local anesthetic agent. The total dose will be adjusted according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. Based on evidence from the literature, an injection volume of 25-30 mL of bupivacaine generally provides adequate spread in the majority of patients.
All block procedures will be performed by an experienced anesthesiologist and a resident physician involved in the study. Following block administration, all patients will undergo general anesthesia, and thoracic surgical procedures will subsequently be performed via thoracotomy by the thoracic surgery team. Receives: Other: Paravertebral Block (PVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Postoperative Pain Intensity
Pain severity will be evaluated using the Numeric Rating Scale (NRS; 0-10), with 0 indicating no pain and 10 indicating the worst imaginable pain.
Measured: Postoperative pain evaluations will be performed and recorded at predefined intervals during the first 24 postoperative hours, namely at 0, 1, 6, 12, and 24 hours after surgery.
Assessment of Postoperative Shoulder Pain
Postoperative shoulder pain will be evaluated based on its presence or absence and quantified using the Numeric Rating Scale (NRS).The occurrence, duration, and severity of shoulder pain will be documented throughout the study period.
Measured: Postoperative shoulder pain evaluations will be recorded at predetermined intervals during the first 24 hours postoperatively, namely at 0, 1, 6, 12, and 24 hours.Furthermore, shoulder pain assessments will be repeated at the one-month postoperative foll
Secondary outcomes (6)
Assessment of Respiratory Function Using the Triflow Device
The Triflow device is an incentive spirometer that is activated by the patient's inspiratory effort and is used for the objective assessment of pulmonary function following thoracic surgery. Preoperatively, patients will be instructed on the proper use of the Triflow device and will perform a practice breathing exercise. The maximum number of balls elevated during this maneuver will be recorded as the baseline measurement.
The intensity of pain experienced during Triflow performance will be evaluated and documented using the Numeric Rating Scale (NRS).
Measured: The same assessment will be repeated at 0, 1, 6, 12, and 24 hours postoperatively, and changes in Triflow performance over time will be evaluated. Pain experienced during Triflow performance will be assessed and documented using the Numeric Rating Scale
Postoperative Analgesic Requirement
All patients will receive intravenous patient-controlled analgesia (PCA) for postoperative pain management. The total opioid (morphine) consumption during the first 24 postoperative hours will be recorded and expressed in milligrams (mg).
Measured: during the first 24 postoperative hours
Assessment of Additional Analgesic Use and Rescue Analgesia Requirements
In addition to intravenous morphine patient-controlled analgesia (PCA) and the institution's routine postoperative analgesic protocol, the presence of any additional analgesic requirements will be recorded.
Measured: during the first 24 postoperative hours
Assessment of Block-Related Complications and Adverse Events
Patients will be monitored for potential block-related complications, including pneumothorax, hematoma formation, injection-site pain, block failure, and local anesthetic systemic toxicity (LAST). All adverse events will be systematically documented throughout the study period.
Measured: during the first 24 postoperative hours
Assessment of Patient Satisfaction and Overall Comfort
Patient satisfaction will be evaluated at 24 hours postoperatively and again during the 1-month follow-up assessment. Satisfaction levels will be assessed using a 5-point Likert scale.
Measured: at 24 hours postoperatively and at the first postoperative month
Effects on Early Mobilization and Respiratory Function
The time to first mobilization, defined as the time at which the patient first stands up following surgery, will be recorded.Patients will be assessed to determine whether pain had a limiting effect on mobilization.
Measured: during the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Jan 2026
- Primary completion10 Aug 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postthoracotomy PainStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Batmazlar, Ankara City Hospital Bilkent
- Investigators
- hülya yiğit, Principal investigator, ankara bilkent şehir hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768826
- Sponsor's protocol ID
- 1251339
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akin AN, Yildiz Y, Alver S, Ciftci B. Continuous serratus posterior superior intercostal plane block for postoperative analgesia management in the patient who underwent right atrial mass excision: a case report. BMC Anesthesiol. 2024 Apr 25;24(1):159. doi: 10.1186/s12871-024-02535-4.
PubMed 38664657Alver S, Bidak M, Erdogan C, Ciftci B. A Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Minimally Invasive Pectus Excavatum Repair Surgery with a Video-Assisted Thoracic Surgery Technique: Case Report. A A Pract. 2024 Apr 3;18(4):e01773. doi: 10.1213/XAA.0000000000001773. eCollection 2024 Apr 1.
PubMed 38569154Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
PubMed 36883093
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serratus Posterior Superior Intercostal Plane Block and Paravertebral Block for Post-Thoracotomy Pain Management
- ClinicalTrials.gov ID
- NCT07768826
- Acronym / sponsor ID
- 1251339
- Conditions
- Postthoracotomy Pain
- Keywords
- Paravertebral Block, Serratus Posterior Superior Intercostal Plane Block, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 17 Aug 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.
Patients undergoing thoracic surgery via thoracotomy are required to remain in the lateral decubitus position for prolonged periods due to surgical access requirements. This positioning is considered one of the major contributors to postoperative shoulder pain, particularly because of the mechanical stress imposed on the dependent shoulder and scapulothoracic region. The resulting pain not only reduces patient comfort but may also delay early mobilization, thereby adversely affecting respiratory function and the recovery of postoperative pulmonary capacity . Therefore, in thoracic surgery, the ability of regional anesthesia techniques to provide sensory coverage extending beyond the incision site to include dermatomes associated with the shoulder girdle has emerged as a critical factor influencing analgesic efficacy.
In this context, the present study aims to comprehensively compare Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Thoracic Paravertebral Block (PVB) with respect to both the management of post-thoracotomy postoperative shoulder pain and their overall analgesic effectiveness. Furthermore, the contribution of these two techniques to postoperative pain management will be thoroughly evaluated in terms of patient comfort and safety profiles.
Detailed description
Thoracotomy is a commonly performed approach in thoracic surgery and is associated with severe postoperative pain due to extensive tissue dissection and rib retraction. Inadequate control of postoperative pain may lead to serious complications, including impaired respiratory function, secretion retention, atelectasis, pneumonia, chronic post-thoracotomy pain syndrome, and reduced patient satisfaction . Therefore, identifying effective, safe, and sustainable analgesic strategies following thoracotomy is of critical importance for improving both patient comfort and clinical outcomes.
Thoracic epidural analgesia (TEA) has long been considered one of the most widely used techniques for postoperative pain control in thoracic surgery. Although TEA provides effective bilateral somatic and visceral analgesia, its clinical use is limited by several factors, including hypotension, urinary retention, motor blockade, epidural hematoma, technical challenges, and the requirement for patient cooperation. Consequently, in addition to systemic analgesics, regional anesthesia techniques have become essential components of multimodal analgesia protocols in thoracic surgery . This has encouraged the development of alternative approaches that are less invasive, technically more feasible, and capable of providing comparable analgesic efficacy. Fascial plane blocks, such as paravertebral block (PVB), erector spinae plane block (ESPB), serratus anterior plane block, and serratus posterior plane blocks, have gained increasing attention because they can be performed within more superficial anatomical planes and are associated with a lower risk of complications . These techniques are particularly considered safe alternatives in patients for whom epidural analgesia is contraindicated or technically challenging .
Thoracic paravertebral block (PVB), one of the techniques evaluated in the present study, provides effective control of both somatic and visceral pain through direct blockade of the thoracic spinal nerves. Despite its relatively deep anatomical location, PVB has demonstrated efficacy in numerous clinical settings and has been widely adopted in clinical practice. It has been successfully utilized in major thoracic procedures, including open thoracotomy, video-assisted thoracoscopic surgery (VATS), breast surgery, management of rib fractures, and extensive thoracic operations such as pneumonectomy and lobectomy. However, due to its deep anatomical location, PVB is associated with technical challenges and potential complications, including pneumothorax and vascular injury .
As an alternative approach, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) has emerged as a novel regional anesthesia technique offering a technically simpler and anatomically safer profile owing to its more superficial site of administration. This block is performed by injecting local anesthetic between the serratus posterior superior muscle and the second or third intercostal muscles. Following injection, the spread of local anesthetic may extend to the dorsal rami, lateral cutaneous branches of the intercostal nerves, and the paravertebral space. Consequently, SPSIPB can provide extensive sensory blockade covering dermatomes from T2 to T9 .
The potential of SPSIPB to achieve broad dermatomal coverage and provide segmental analgesia comparable to that of PVB has been supported by cadaveric studies and case series reported in the literature. Anatomical and technical descriptions have demonstrated that the sensory distribution of SPSIPB may extend from C3 to T10 dermatomes . Such extensive spread suggests that SPSIPB may provide effective analgesia for upper thoracic regions.
The analgesic efficacy of SPSIPB has also been demonstrated in procedures involving anatomical regions similar to thoracic surgery, including video-assisted thoracoscopic surgery (VATS), reduction mammaplasty, cardiac surgery, and pectus excavatum repair, as reported in several case studies and clinical reports. However, prospective studies directly comparing SPSIPB and PVB in patients undergoing open thoracotomy remain limited.
In this context, the primary objective of the present study is to compare the efficacy of SPSIPB and PVB in providing postoperative analgesia in patients undergoing thoracic surgical procedures performed via thoracotomy and to contribute to the optimization of postoperative pain management strategies in thoracic surgery.
Patients undergoing thoracic surgery via thoracotomy are required to remain in the lateral decubitus position for prolonged periods to facilitate surgical exposure. This positioning is considered one of the major contributors to postoperative shoulder pain, primarily due to the mechanical stress imposed on the non-dependent shoulder and scapulothoracic region. The resulting pain not only compromises patient comfort but may also delay early mobilization, thereby adversely affecting respiratory function and the recovery of postoperative pulmonary capacity . Therefore, the ability of regional anesthesia techniques used in thoracic surgery to provide sensory blockade extending beyond the surgical incision site to include dermatomes associated with the shoulder girdle has emerged as an important determinant of analgesic success.
Accordingly, the present study aims to comprehensively compare SPSIPB and PVB with regard to both the management of post-thoracotomy postoperative shoulder pain and their overall analgesic efficacy. Furthermore, the contribution of these two techniques to postoperative pain management will be thoroughly evaluated in terms of patient comfort and safety profiles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block | Experimental | Other: Serratus Posterior Superior Intercostal Plane Block (SPSIPB)In this study, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) will be performed under ultrasound guidance using an in-plane technique at the level of the superomedial border of the scapula. The block will be administered by injecting local anesthetic into the interfascial plane between the serratus posterior superior muscle and the second or third intercostal muscle. Bupivacaine at a concentration of 0.25% will be used as the local anesthetic agent. The total dose administered will be calculated according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. In routine clinical practice, an injection volume of 25-30 mL of bupivacaine is generally sufficient to achieve an effective block in most patients. |
| Paravertebral Block | Active comparator | Other: Paravertebral Block (PVB)Thoracic Paravertebral Block (PVB) will be performed under ultrasound guidance using an in-plane technique at the T4-T6 thoracic vertebral levels. The needle tip will be advanced into the paravertebral space located between the transverse process and the parietal pleura. For PVB, 0.25% bupivacaine will be used as the local anesthetic agent. The total dose will be adjusted according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. Based on evidence from the literature, an injection volume of 25-30 mL of bupivacaine generally provides adequate spread in the majority of patients. All block procedures will be performed by an experienced anesthesiologist and a resident physician involved in the study. Following block administration, all patients will undergo general anesthesia, and thoracic surgical procedures will subsequently be performed via thoracotomy by the thoracic surgery team. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled to undergo elective thoracic surgery via thoracotomy
- Patients aged between 18 and 75 years
- Patients classified as American Society of Anesthesiologists (ASA) physical status I-III
- Patients who provide written informed consent to participate in the study
Key exclusion criteria (13 listed)
- Patients with a known allergy or hypersensitivity to local anesthetic agents
- Patients with coagulation disorders or those receiving anticoagulant therapy
- Pregnant or breastfeeding women
- Patients with impaired consciousness or inability to communicate effectively
- Patients in whom block administration is unsuccessful
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 |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block (SPSIPB)In this study, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) will be performed under ultrasound guidance using an in-plane technique at the level of the superomedial border of the scapula. The block will be administered by injecting local anesthetic into the interfascial plane between the serratus posterior superior muscle and the second or third intercostal muscle. Bupivacaine at a concentration of 0.25% will be used as the local anesthetic agent. The total dose administered will be calculated according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. In routine clinical practice, an injection volume of 25-30 mL of bupivacaine is generally sufficient to achieve an effective block in most patients. | Other | Serratus Posterior Superior Intercostal Plane Block |
| Paravertebral Block (PVB)Thoracic Paravertebral Block (PVB) will be performed under ultrasound guidance using an in-plane technique at the T4-T6 thoracic vertebral levels. The needle tip will be advanced into the paravertebral space located between the transverse process and the parietal pleura. For PVB, 0.25% bupivacaine will be used as the local anesthetic agent. The total dose will be adjusted according to the patient's body weight and will not exceed the maximum recommended dose of 2 mg/kg. Based on evidence from the literature, an injection volume of 25-30 mL of bupivacaine generally provides adequate spread in the majority of patients. All block procedures will be performed by an experienced anesthesiologist and a resident physician involved in the study. Following block administration, all patients will undergo general anesthesia, and thoracic surgical procedures will subsequently be performed via thoracotomy by the thoracic surgery team. | Other | Paravertebral Block |
Primary outcome
Assessment of Postoperative Pain Intensity
Time frame: Postoperative pain evaluations will be performed and recorded at predefined intervals during the first 24 postoperative hours, namely at 0, 1, 6, 12, and 24 hours after surgery.
Pain severity will be evaluated using the Numeric Rating Scale (NRS; 0-10), with 0 indicating no pain and 10 indicating the worst imaginable pain.
Assessment of Postoperative Shoulder Pain
Time frame: Postoperative shoulder pain evaluations will be recorded at predetermined intervals during the first 24 hours postoperatively, namely at 0, 1, 6, 12, and 24 hours.Furthermore, shoulder pain assessments will be repeated at the one-month postoperative foll
Postoperative shoulder pain will be evaluated based on its presence or absence and quantified using the Numeric Rating Scale (NRS).The occurrence, duration, and severity of shoulder pain will be documented throughout the study period.
6 secondary outcomes
Assessment of Respiratory Function Using the Triflow Device
Time frame: The same assessment will be repeated at 0, 1, 6, 12, and 24 hours postoperatively, and changes in Triflow performance over time will be evaluated. Pain experienced during Triflow performance will be assessed and documented using the Numeric Rating Scale
Postoperative Analgesic Requirement
Time frame: during the first 24 postoperative hours
Assessment of Additional Analgesic Use and Rescue Analgesia Requirements
Time frame: during the first 24 postoperative hours
Assessment of Block-Related Complications and Adverse Events
Time frame: during the first 24 postoperative hours
Assessment of Patient Satisfaction and Overall Comfort
Time frame: at 24 hours postoperatively and at the first postoperative month
Effects on Early Mobilization and Respiratory Function
Time frame: during the first 24 postoperative hours
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 28 Oct 2026.
- Results publication: PubMed 38664657Akin AN, Yildiz Y, Alver S, Ciftci B. Continuous serratus posterior superior intercostal plane block for postoperative analgesia management in the patient who underwent right atrial mass excision: a case report. BMC Anesthesiol. 2024 Apr 25;24(1):159. doi: 10.1186/s12871-024-02535-4.
- Results publication: PubMed 38569154Alver S, Bidak M, Erdogan C, Ciftci B. A Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Minimally Invasive Pectus Excavatum Repair Surgery with a Video-Assisted Thoracic Surgery Technique: Case Report. A A Pract. 2024 Apr 3;18(4):e01773. doi: 10.1213/XAA.0000000000001773. eCollection 2024 Apr 1.
- Results publication: PubMed 36883093Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Individual participant dataSharing planned: No
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.
hülya yiğit principal investigator
ankara bilkent şehir hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Paravertebral Block (PVB) in people with Postthoracotomy Pain, run by Ankara City Hospital Bilkent 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 13 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 28 Oct 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?
Assessment of Postoperative Pain Intensity (time frame: Postoperative pain evaluations will be performed and recorded at predefined intervals during the first 24 postoperative hours, namely at 0, 1, 6, 12, and 24 hours after surgery.). The study lists 2 primary outcomes in all. 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 NCT07768826, which also lists 3 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 28 Oct 2026.