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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07768826
Study groupRoleWhat they receive
Serratus Posterior Superior Intercostal Plane BlockExperimentalIn 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 BlockActive comparatorThoracic 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.

  1. 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.

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted17 Aug 2026
  2. Study start1 Jan 2026
  3. Primary completion10 Aug 2026
  4. Study completion25 Sep 2026

Resources

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)
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 38664657
  • Alver 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 38569154
  • Tulgar 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

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.

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