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Recruiting NCT07335250

Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy

No phase Interventional Acute Postoperative Pain Thoracotomy Surgery Intertransverse Process Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intertransverse Process Block, Placebo.
Who it may be relevant to
Registry conditions: Acute Postoperative Pain, Thoracotomy Surgery, Intertransverse Process Block. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Intertransverse Process Block
    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 superi
  • Procedure Placebo
    In the control group, the same procedure will be conducted, but saline will be injected instead of local anesthetic.

Primary outcome measures

  • Morphine Consumption Within the First 24 Hours After Surgery [Time frame: 24 hours postoperatively]
Secondary outcome measures (1)
  • NRS score [Time frame: 0 to 24 hours postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Konya City Hospital — Konya

Identifiers

NCT: NCT07335250 · 2025/485

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗