Analgesic Efficacy of Intertransverse Process Block Versus Erector Spinae Plane Block

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAntalya City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Refusal to participate

Allergy to local anesthetics

Infection at the injection site

Coagulopathy or ongoing anticoagulant therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intertransverse Process Block (ITP)

    Procedure/Surgery

    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.

  • The Erector Spinae Plane Block (ESP)

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intertransverse Process Block (ITP)Active comparator 1 intervention
Group B: The Erector Spinae Plane Block (ESP)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Total opioid consumption via patient-controlled analgesia (PCA)

Time frame
Within the first 24 hours postoperatively
2

Requirement for rescue analgesia

Time frame
Within the first 24 hours postoperatively
3

Block-related and systemic side effects

Time frame
Within the first 24 hours postoperatively
4

Patient satisfaction assessed using a Likert scale

Patient satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.

Time frame
At 24 hours postoperatively

Other outcomes

Sponsors and contacts

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