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

NCT07504705 | Not Yet Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/141
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acut Postoperative Pain; Erector Spinae Plane Block; Intertransverse Process Block

Keywords

Laparoscopic Cholecystectomy; Erector Spinae Plane Block; Intertransverse Process Block; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Opioid consumption

  0 to 24 hours postoperatively

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Procedure: Erector Spinae Plane Block

Intertransverse Process Block

ACTIVE COMPARATOR

Procedure: Intertransverse Process Block

Interventions

Intertransverse Process Block PROCEDURE

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.

Intertransverse Process Block

Erector Spinae Plane Block PROCEDURE

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.

Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Konya, 42290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Ömer Keklicek, Principal Investigator

CONTACT

+905399291702; drokeklicek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Eligible patients will be allocated into two groups-the ITPB group and the ESPB group-in a 1:1 ratio. Randomization will be performed using a computer-generated algorithm with variable block sizes (4-8). The randomly generated codes will be maintained by non-study personnel and will remain inaccessible to the investigators. The randomization sequence will be placed in sequentially numbered, opaque, sealed envelopes by a staff member not involved in the study. Through this methodology, triple-blinding will be ensured: the patient, the outcome assessor, and the data analyst will remain blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Participants will be randomized into two parallel groups to receive either an ultrasound-guided intertransverse process block (ITPB) or an erector spinae plane block (ESPB). Each participant will receive only one intervention, and postoperative outcomes will be compared between the two groups. This study aims to provide a 'head-to-head' comparison between these two active regional anesthesia techniques.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 25, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)