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NCT Number: NCT07335250

Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy

This prospective, randomized, triple-blind, placebo-controlled clinical trial will investigate the effectiveness of the intertransverse process block (ITPB) for postoperative analgesia in patients undergoing elective thoracotomy with unilateral lobectomy. The study will be conducted at a single tertiary center in accordance with the principles of the Declaration of Helsinki, and written informed consent will be obtained from all participants.

Patients will be randomized in a 1:1 ratio to receive either ultrasound-guided ITPB with 0.5% bupivacaine or placebo (normal saline) prepared in identical syringes to ensure allocation concealment. The block will be performed by an experienced anesthesiologist immediately after surgery and before emergence from anesthesia. Both groups will receive standardized general anesthesia, multimodal perioperative analgesia, and postoperative intravenous morphine patient-controlled analgesia (PCA).

The trial aims to evaluate the analgesic efficacy and opioid-sparing effect of ITPB while maintaining safety and adherence to routine clinical practice. Outcomes will include postoperative pain scores, opioid consumption, rescue analgesia requirement, and adverse events.

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Key information

Conditions

Acute Postoperative Pain Intertransverse Process Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thoracotomy Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of written informed consent

Age between 18 and 85 years

ASA Physical Status classification I-III

Elective thoracotomy with planned unilateral lobectomy

Anticipated hospital stay of at least one night

Expected requirement for parenteral opioid analgesia for at least 24 hours postoperatively

Ability to operate an intravenous patient-controlled analgesia (PCA) device

Exclusion criteria

  • Patients undergoing emergency surgery

Presence of infection or open wound at the injection site

Coagulopathy

Hepatic or renal failure

Patients undergoing reoperation

Patients with missing or incomplete data

Pregnancy or lactation

Tracheal malformation or tracheostomy

Chronic opioid use (≥30 days within the last 3 months, ≥15 mg/day morphine equivalent)

Patients exceeding the maximum safe local anesthetic dose based on weight (2.5 mg/kg, max 150 mg)

Patients who refuse data privacy consent will be excluded from the study

Treatment and study plan

Intertransverse Process Block

Procedure

The block will be performed under ultrasound guidance by the same anesthesiologist with more than five years of experience, immediately after surgery and before emergence from anesthesia. Patients will be placed in the lateral decubitus position with the operative side uppermost and the skin prepared.

Using a high-frequency linear probe (Mindray DC-60 Exp), the T5 spinous process will be identified at the midline, then the probe will be moved approximately 2 cm laterally to visualize the superior costotransverse ligament (SCTL) and pleura. The needle will be advanced in-plane in a caudal-to-cranial direction toward the cranial border of the fourth rib. After confirmation of correct spread by hydrodissection, 20 mL of 0.5% bupivacaine will be injected.

Placebo

Procedure

In the control group, the same procedure will be conducted, but saline will be injected instead of local anesthetic.

Primary outcomes

  1. Morphine Consumption Within the First 24 Hours After Surgery

    Time frame: 24 hours postoperatively

    The primary objective of the study is to evaluate the effect of the intertransverse process block (ITPB) on opioid consumption within the first 24 hours postoperatively in patients undergoing thoracotomy with unilateral lobectomy. Morphine consumption will be determined based on patient-controlled analgesia (PCA) use.

Secondary outcomes

  1. NRS score

    Time frame: 0 to 24 hours postoperatively

    After extubation, patients will be assessed at 0, 6, 12, and 24 hours for pain intensity both at rest and during coughing using the Numeric Rating Scale (NRS; 0-10).

    The Numeric Rating Scale ranges from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating worse pain severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Omer Keklicek, Principal Investigator

CONTACT

[email protected]

+905399291702

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Postoperative Pain Control With Intertransverse Process Block in Patients Undergoing Thoracotomy With Lobectomy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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