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NOT YET RECRUITING
NCT07504705
NA

Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients

Sponsor: Konya City Hospital

View on ClinicalTrials.gov

Summary

Laparoscopic cholecystectomy is considered the gold standard for the surgical treatment of benign gallbladder diseases; however, despite its minimally invasive nature, a significant proportion of patients experience substantial early postoperative pain, which impacts patient comfort and the duration of hospital stay. The current PROSPECT review and previous studies emphasize that this pain is multifactorial-comprising somatic, visceral, and phrenic nerve-mediated shoulder-tip components-and therefore advocate for an opioid-sparing multimodal analgesic approach. Within this framework, first-line recommendations include paracetamol, NSAIDs/COX-2 inhibitors, dexamethasone, and local anesthetic infiltration of the surgical site and/or intraperitoneal cavity, alongside appropriate regional blocks; opioids should be reserved solely for rescue analgesia \[1-3\]. Ultrasound-guided regional anesthesia blocks are increasingly utilized for acute visceral pain conditions, such as renal colic \[4\]. The Erector Spinae Plane Block (ESPB) is an interfacial block performed in the thoracic paraspinal region, and it is hypothesized that its extensive spread may influence somatic and, to some extent, visceral pain pathways \[5\]. Nevertheless, anatomical and clinical studies report inconsistent effects of ESPB on visceral pain, noting that local anesthetics may not consistently reach the paravertebral space, thereby leading to variable block efficacy \[6,7\]. Consequently, the Intertransverse Process Block (ITPB), which targets a plane anatomically closer to the paravertebral space, has been described in recent years as an alternative technique. ITPB is performed by injecting local anesthetic into the interfacial space adjacent to the retro-superior costotransverse ligament; it is reported to carry a low risk of complications as it does not require direct orientation toward the pleura or neuraxial structures \[8\]. Clinical trials indicate that ITPB provides analgesic efficacy comparable to paravertebral blocks in both thoracic and abdominal surgeries and reduces opioid consumption \[9\]. Furthermore, anatomical studies suggest that the probability of local anesthetic spread into the paravertebral space is higher with ITPB than with ESPB \[10\]. However, a randomized controlled trial comparing ESPB and ITPB in patients undergoing laparoscopic cholecystectomy is currently lacking in the literature. Therefore, the present study was designed to address this gap.

Official title: Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients: A Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-05-01

Completion Date

2027-05-25

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

PROCEDURE

Intertransverse Process Block

The ITPB will be performed using the same ultrasound (US) device. Initially, the spinous process of the T8 vertebra will be visualized in the horizontal plane at the midline using a linear probe. The probe will then be shifted approximately 2 cm laterally to the right and left of the midline in the longitudinal plane to visualize the superior costotransverse ligament (SCTL) spanning between the transverse processes and the pleura. The block needle will be advanced in-plane in a caudal-to-cranial direction, parallel to the SCTL, and stopped just before reaching the cranial aspect of the eighth rib. After the space is confirmed via hydrodissection, 20 mL of 0.375% bupivacaine (not exceeding a maximum dose of 2.5 mg/kg) will be injected without penetrating the SCTL, while simultaneously monitoring the volume spread via US. The block will be performed unilaterally at the level of the right hemithorax.

PROCEDURE

Erector Spinae Plane Block

The ESPB will be performed in the sitting position under ultrasound (US) guidance using a 6-10 MHz linear ultrasound probe (Mindray DC-60 Exp; Mindray Bio-Medical Electronics, Shenzhen, China). The transverse process and erector spinae muscles at the T8 level will be visualized in a longitudinal parasagittal plane. An echogenic 22 G, 80 mm needle (Stimuplex A, B. Braun, Melsungen, Germany) will be advanced in-plane in a caudal-to-cranial direction until contact is made with the transverse process beneath the erector spinae muscle. Following negative aspiration, 20 mL of 0.5% bupivacaine will be injected, ensuring visualization of the spread within the fascial plane. The block will be performed unilaterally on the right hemithorax.

Locations (1)

Konya City Hospital

Konya, Konya, Turkey (Türkiye)