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

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

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.

Ultrasound-guided regional anesthesia blocks are increasingly utilized for acute visceral pain conditions, such as renal colic. 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. 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.

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. Clinical trials indicate that ITPB provides analgesic efficacy comparable to paravertebral blocks in both thoracic and abdominal surgeries and reduces opioid consumption. Furthermore, anatomical studies suggest that the probability of local anesthetic spread into the paravertebral space is higher with ITPB than with ESPB.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erector Spinae Plane Block; Intertransverse Process Block; Acut Postoperative Pain
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: Intertransverse Process Block

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ömer Keklicek, Principal Investigator; Phone Number: +905399291702; Email: drokeklicek@gmail.com

Study Locations

• Turkey (Türkiye)
  • Konya
    • Konya, Konya, Turkey (Türkiye), 42290
      • Konya City Hospital
      • Contact: Ömer Keklicek, Principal Investigator; Phone Number: 05399291702; Email: konyash@saglik.gov.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing elective laparoscopic cholecystectomy
• Body mass index (BMI) between 18 and 35 kg/m²
• American Society of Anesthesiologists (ASA) physical status score of I-III
• Ability to provide written and verbal informed consent

Exclusion Criteria:

• Coagulopathy or use of anticoagulant medications
• Infection at the injection site
• Allergy to local anesthetics
• Pregnancy or breastfeeding
• Chronic opioid use or analgesic dependence
• Severe cardiopulmonary disease or psychiatric disorders
• Previous regional block performed within the last 24 hours
• Patients requiring emergency surgery
• Cases converted from laparoscopic surgery to open surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector Spinae Plane Block	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.
Active Comparator: Intertransverse Process Block	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Score	The primary objective of this study is to compare the effects of ESPB and ITPB techniques on Numeric Rating Scale (NRS) pain scores in patients undergoing laparoscopic cholecystectomy. You hypothesis is that NRS scores will be lower in patients receiving ITPB compared to the ESPB group, as the ITPB is expected to provide more extensive visceral analgesia. Pain Assessment: Numeric Rating Scale (NRS) Pain intensity will be reported using the Numeric Rating Scale (NRS): Scale Range: Scores range from a minimum of 0 to a maximum of 10. Interpretation: A score of 0 represents "no pain," while a score of 10 represents the "worst possible pain." Consequently, higher scores indicate a worse outcome (increased pain severity), while lower scores indicate superior analgesic efficacy.	0 to 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	The secondary objective of the study is to evaluate the effects of ESPB and ITPB on opioid consumption. The amounts of rescue analgesic (tramadol) administered in the post-block period will be recorded. You hypothesis is that opioid requirements will be lower in patients receiving ITPB compared to the ESPB group, due to the provision of more effective analgesia.	0 to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 25, 2027

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Laparoscopic Cholecystectomy; Erector Spinae Plane Block; Intertransverse Process Block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: B.30.2.ATA.0.01.00/141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No