Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

NCT ID: NCT05448495

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2023-09-15

Brief Summary

To compare the analgesic efficacy of posterior TAP block versus ESPB after PCNL surgery. The hypothesis is that posterior TAP block, as a part of multimodal analgesia, will reduce pain and opioid consumption like ESPB

Detailed Description

Percutaneous nephrolithotomy (PCNL) is currently the gold standard for treatment of patients with large and complex renal calculi because it is less invasive than open surgery. The sources of acute pain after PCNL are visceral pain originating from kidneys and ureters, and somatic pain from the site incision. PCNL is usually done in 10th to 11th intercostal space or in the subcostal area. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as thoracic paravertebral block, transversus abdominis plane (TAP) block, erector spinae plane block (ESPB).

ESPB is an interfascial block which can provide wide sensory blockade from T2-4 to L1-2 that was first described in 2016. ESPB can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle with nearly one dermatome for each 3.4 ml of the injected volume. This allows ESPB to provide both visceral and somatic analgesia. TAP block is a regional injection of a local anesthetic agent between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1). Various technical modifications in TAP block have been described including lateral, posterior, subcostal, and continuous catheter techniques. The posterior approach should be the preferred technique in clinical practice as it provides longer somatic and visceral analgesia that are not offered with the lateral approach.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Posterior TAP block

Group Type: EXPERIMENTAL

Posterior TAP block

Intervention Type: OTHER

Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \[0.5 mcg\\kg\] + 2ml dexamethasone \[0.1mg\\kg)\] will be injected at the plane between internal oblique and transversus abdominis near the aponeurosis at the posterior axillary line.

ESPB

Group Type: ACTIVE_COMPARATOR

ESPB

Intervention Type: OTHER

Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \[0.5 mcg\\kg\] + 2ml dexamethasone \[0.1mg\\kg)\] will be injected at T9 erector spinae plane

Interventions

Posterior TAP block

Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \[0.5 mcg\\kg\] + 2ml dexamethasone \[0.1mg\\kg)\] will be injected at the plane between internal oblique and transversus abdominis near the aponeurosis at the posterior axillary line.

Intervention Type: OTHER

ESPB

Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine \[0.5 mcg\\kg\] + 2ml dexamethasone \[0.1mg\\kg)\] will be injected at T9 erector spinae plane

Intervention Type: OTHER

Other Intervention Names

Posterior transversus abdominis plane block; Erector spinae plane block

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for PCNL under general anesthesia
• ASA status I-II

Exclusion Criteria

1. Contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics)

2. Patient who has difficulty understanding the study protocol or patient refusal.

3. Chronic respiratory disease patients.

4. Diabetic patients.

5. Body mass index (BMI) > 30 Kg/m2

6. Routine corticosteroids, pain medication, or anticonvulsant.

7. Psychiatric diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

FATMA NABIL AHMED MOHAMED

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Fatma Nabil, M.D.

Role: CONTACT

fatmanabil2012@aun.edu.eg

+201003633992

Facility Contacts

Fatma Nabil, M.D.

Role: primary

fatmanabil2012@aun.edu.eg

+201003633992

Other Identifiers

Posterior TAPB versus ERSPB

Identifier Type: -

Identifier Source: org_study_id