Acute Postoperative Pain, Thoracotomy Surgery, Intertransverse Process Block
Conditions
Keywords
Intertransverse Process Block, Thoracotomy Lobectomy, Acute Postoperative Pain
Brief summary
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
PROCEDUREIntertransverse 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 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.
PROCEDUREPlacebo
In the control group, the same procedure will be conducted, but saline will be injected instead of local anesthetic.
Sponsors
Konya City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The study is triple-blinded. Neither the participants, the block performer, nor the outcome assessors are aware of the group assignments. Randomization codes are stored centrally, and a separate staff member who is not involved in patient care or outcome assessment prepares the study solutions and labels them in an identical manner to maintain allocation concealment.
Intervention model description
Participants will be randomized into two parallel groups to receive either an ultrasound-guided intertransverse process block with bupivacaine or a placebo saline injection at the same site. Each participant will receive only one intervention, and postoperative outcomes will be compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption Within the First 24 Hours After Surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| NRS score | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTOmer Keklicek, Principal Investigator
Outcome results
None listed