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Analgesic Efficacy of SPSIP Block Versus Paravertebral Block Following Thoracotomy

Comparison of Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Paravertebral Block for Postoperative Analgesia After Thoracotomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07275047
Enrollment
80
Registered
2025-12-10
Start date
2025-12-15
Completion date
2026-12-15
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-thoracotomy Pain

Keywords

Post-thoracotomy pain, Serratus posterior superior intercostal plane block, Paravertebral Block, Pain management

Brief summary

Thoracotomy causes severe postoperative pain that may impair respiratory function and increase complications. This study compares the postoperative analgesic effectiveness of the serratus posterior superior intercostal plane (SPSIP) block and the paravertebral block in patients undergoing thoracotomy. The aim is to determine whether the newly described serratus posterior superior intercostal plane block can serve as a safe and effective alternative to established techniques.

Detailed description

Thoracotomy often causes strong postoperative pain because the ribs, muscles, nerves, and pleura are affected during surgery. This pain can make it difficult for patients to breathe well and may increase the chance of lung problems. Paravertebral block is a well-known method for reducing pain after thoracic surgery, but it can sometimes lead to side effects such as low blood pressure or complications related to deeper needle placement. The serratus posterior superior intercostal plane block is a newer ultrasound-guided technique. In this method, local anesthetic is injected between the serratus posterior superior muscle and the intercostal muscles. Early studies suggest that it may provide wide pain relief, but its effectiveness specifically in thoracotomy patients has not yet been studied. This randomized study aims to compare the pain-relieving effects of the serratus posterior superior intercostal plane block with those of the paravertebral block after thoracotomy. The goal is to find out whether this new block can be a safe and effective option for postoperative pain management.

Interventions

PROCEDURESerratus Posterior Superior Intercostal Plane Block

Ultrasound-guided regional anesthesia technique performed between the serratus posterior superior muscle and intercostal muscles.

PROCEDUREThoracic Paravertebral Block

Ultrasound-guided injection of local anesthetic into the thoracic paravertebral space to provide unilateral analgesia.

Sponsors

Bursa City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Scheduled to undergo thoracotomy * ASA physical status I-III according to the American Society of Anesthesiologists classification * Able to understand the study procedures and provide written informed consent

Exclusion criteria

* Declines or is unable to provide informed consent * Allergy or hypersensitivity to local anesthetics or opioids * Known or suspected coagulopathy * Infection at the injection site * History of thoracic surgery * Severe cardiovascular disease * Hepatic or renal failure * Pregnant, suspected pregnancy, or breastfeeding Significant neurological or psychiatric disorder that may interfere with study participatio

Design outcomes

Primary

MeasureTime frameDescription
Postoperative 24-Hour PCA Opioid ConsumptionPostoperative 24 hoursTotal amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).

Secondary

MeasureTime frameDescription
Chronic Pain Assessment3 months postoperativelyPain status using the Brief Pain Inventory (BPI) via telephone follow-up. General Scoring: The BPI comprises the Pain Severity and Pain Interference subscales. Each item is scored on a 0 (None/No interference) to 10 (Worst imaginable/Completely disabling) numerical scale. Higher scores indicate a worse clinical outcome. Subscale scores are calculated by taking the arithmetic mean of relevant items. 1. Pain Severity Subscale (4 Items): Assesses pain intensity over the last 24 hours. (0-10) What is your pain level right now What was your pain at its least in the last 24 hours What was your pain at its worst in the last 24 hours What was your pain on average in the last 24 hours 2. Pain Interference Subscale (7 Items): Assesses the degree to which pain interferes with daily functioning Questions: The patient rates how much pain interfered with: (0-10) General activity Mood Walking ability Normal work Relations with people Sleep Enjoyment of life
Rescue Analgesic RequirementPostoperative 0-48 hoursNumber of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4.
NRS Pain Scores at Rest and Movement2, 4, 8, 16, 24, and 48 hours postoperativelyNumeric Rating Scale (NRS) (0-10) pain scores at rest and during movement or coughing at predefined postoperative hours.
QoR-15 Recovery ScoreThe quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.]The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed

Countries

Turkey (Türkiye)

Contacts

CONTACTMursel Ekinci, Assoc prof,MD
drmurselekinci@gmail.com+905067137596
CONTACTMustafa Dikici, MD
mus.dikici88@gmail.com+905055346540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026