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Recruiting NCT07504705

NCT07504705 Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients

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Clinical Trial Summary
NCT ID NCT07504705
Status Recruiting
Phase
Sponsor Konya City Hospital
Condition Acut Postoperative Pain
Study Type INTERVENTIONAL
Enrollment 110 participants
Start Date 2026-05-07
Primary Completion 2027-05-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Intertransverse Process BlockErector Spinae Plane Block

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 110 participants in total. It began in 2026-05-07 with a primary completion date of 2027-05-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Ömer Keklicek, Principal Investigator

✉ drokeklicek@gmail.com

📞 +905399291702

Frequently Asked Questions

Who can join the NCT07504705 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Acut Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07504705 currently recruiting?

Yes, NCT07504705 is actively recruiting participants. Contact the research team at drokeklicek@gmail.com for enrollment information.

Where is the NCT07504705 trial being conducted?

This trial is being conducted at Konya, Turkey (Türkiye).

Who is sponsoring the NCT07504705 clinical trial?

NCT07504705 is sponsored by Konya City Hospital. The trial plans to enroll 110 participants.

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