Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorKonya City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of written informed consent
Disqualifiers
Patients undergoing emergency surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Intertransverse Process Block
Procedure/SurgeryThe 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/SurgeryIn the control group, the same procedure will be conducted, but saline will be injected instead of local anesthetic.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Block Group - Intertransverse Process BlockActive comparator 1 intervention
Group B: Control Group - Placebo:Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 postoperativelySecondary outcomes
1
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 postoperativelySponsors and contacts
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Source ClinicalTrials.gov