Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy

N/ANot Yet RecruitingNCT07335250

Konya City Hospital66 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Postoperative Pain Thoracotomy Surgery

Interventions

Intertransverse Process BlockPROCEDURE

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.

PlaceboPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Morphine Consumption Within the First 24 Hours After Surgery

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.

Time frame: 24 hours postoperatively

Secondary Outcomes

NRS score

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.

Time frame: 0 to 24 hours postoperatively