Analgesic Efficacy of Intertransverse Process Block Versus Erector Spinae Plane Block

NCT07583602 | Not Yet Recruiting

• 1 other identifier: ITPvsESP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITP) and the Erector Spinae Plane (ESP) block in patients undergoing Robotic Colorectal Surgery. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic systemic complications, vascular puncture, and infection), patient and surgeon satisfaction assessed using a Likert scale, and quality of recovery assessed using the QoR-15 questionnaire, and incedence of postoperative nausea and vomiting.

Conditions

Erector Spine Plane Block; Robotic Colorectal Surgery; Intertransverse Process Block; Postoperative Pain

Keywords

esp; ıtp; robotic surgery; colorectal surgery; regional block

Outcome Measures

Primary Outcomes (1)

• postoperative pain intensity (VAS score)

  Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Measurements will be recorded at predefined time points within the first 24 hours after surgery.

  0, 1, 4, 8, 12, and 24 hours after surgery

Secondary Outcomes (7)

• Total opioid consumption via patient-controlled analgesia (PCA)

  Within the first 24 hours postoperatively

• Requirement for rescue analgesia

  Within the first 24 hours postoperatively

• Block-related and systemic side effects

  Within the first 24 hours postoperatively

• Patient satisfaction assessed using a Likert scale

  At 24 hours postoperatively

• Quality of recovery assessed using the QoR-15 questionnaire

  At 24 hours postoperatively

Study Arms (2)

Intertransverse Process Block (ITP)

ACTIVE COMPARATOR

Procedure: Intertransverse Process Block (ITP)

The Erector Spinae Plane Block (ESP)

ACTIVE COMPARATOR

Procedure: The Erector Spinae Plane Block (ESP)

Interventions

Intertransverse Process Block (ITP) PROCEDURE

Intertransverse Process Block (ITP) block will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine. A linear ultrasound probe will be positioned along the medial border of spinous processs level of the 10th thoracic vertebrae. Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T10 level, will be identified. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.

Intertransverse Process Block (ITP)

The Erector Spinae Plane Block (ESP) PROCEDURE

The Erector Spinae Plane Block (ESP) will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine. A linear ultrasound probe will be positioned along the medial border of spinous processs level of the 10th thoracic vertebrae. Anatomical landmarks, including the trapezius muscle, rhomboid major muscle (RMM), erector spinal muscle and transverse processes of the 10th thoracic vertebrae will be identified. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered.

The Erector Spinae Plane Block (ESP)

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-65 years
• ASA physical status I-III
• Scheduled for elective robotic colorectal surgery
• Body mass index (BMI) between 18 and 35 kg/m²
• Ability to understand and use the patient-controlled analgesia (PCA) device
• Ability to provide written informed consent

You may not qualify if:

• Refusal to participate
• Allergy to local anesthetics
• Infection at the injection site
• Coagulopathy or ongoing anticoagulant therapy
• Chronic opioid use or opioid dependence
• Severe hepatic or renal insufficiency
• Pregnancy or breastfeeding
• Cognitive impairment or inability to communicate pain scores
• Body mass index (BMI) \<18 or \>35 kg/m²

Sponsors & Collaborators

• Antalya City Hospital: lead

Study Sites (1)

Antalya City Hospital

Antalya, 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

ENES ESKİN, CONSULTANT İN ANESTHESİOLOGY

CONTACT

+905454738489; eneskin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant in anesthesiology

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)