Analgesic Efficacy of External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy

NCT ID: NCT06584695

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2025-12-01

Brief Summary

To compare the efficacy of unilateral ultrasound-guided oblique subcostal transversus abdominis plane block with unilateral ultrasound-guided external oblique intercostal plane block in providing intraoperative and postoperative analgesia in cancer patients undergoing open nephrectomy.

Detailed Description

Open surgery remains one of the procedures used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of severe immediate postoperative pain and chronic pain the months following surgery.

Regional anesthesia techniques are frequently recommended for pain control in open nephrectomy as they decrease the need for parenteral opioid and improve patient satisfaction.

Although abdominal wall blocks are known to decrease opioid requirements without causing epidural associated hypotension, their role in flank surgeries has been less well-established. The dermatomes that need to be covered in flank incision are T9 to T11.

Studies have confirmed that ultrasound-guided (USG) transversus abdominis plane (TAP) block is an effective method of analgesia for upper abdominal surgeries, lower abdominal surgeries and kidney transplantation with minimal side effects.

The external oblique intercostal (EOI) block is a novel method providing simple and effective somatic analgesia to the upper abdomen with minimal side effects. Other advantages include easy sonoanatomy (even in obese patients), being performed in the supine position, and no anticoagulation concern

Conditions

Analgesic Efficacy; External Oblique Intercostal Block; Subcostal Transversus Abdominis Plane Block; Open; Nephrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transversus abdominis plane group

patients will receive unilateral ultrasound-guided oblique subcostal transversus abdominis plane block block

Group Type: EXPERIMENTAL

Transversus abdominis plane block

Intervention Type: DRUG

Patients will receive transversus abdominis plane block with an oblique subcostal approach in the supine position. The anesthesiologist will place the linear ultrasound transducer obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The anesthesiologist will direct a 22G, 80 mm needle toward the transversus abdominis fascia and inject 25 mL of 0.25% bupivacaine between the rectus abdominis and transversus abdominis muscles along the subcostal line.

External oblique intercostal group

Patients will receive unilateral ultrasound-guided external oblique intercostal block

Group Type: EXPERIMENTAL

External Oblique Intercostal Plane Block

Intervention Type: DRUG

Patients will receive external oblique intercostal block the patient will be in the supine position with their ipsilateral arm abducted, A linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, with the orientation marker directed cranially. The skin will be sterilized, and the probe will be placed over the sixth rib medial to the anterior axillary line in a parasagittal orientation the in-plane technique with a 22G, 80 mm block needle will be used to inject 25 ml of 0.25% bupivacaine into the external oblique intercostal plane.

Control group

Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: DRUG

Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia.

General anesthesia induction will be performed with fentanyl 1-2 μg/kg, propofol 2-3 mg/kg, and rocuronium 0.6 mg/kg and maintained with sevoflurane.

Interventions

Transversus abdominis plane block

Patients will receive transversus abdominis plane block with an oblique subcostal approach in the supine position. The anesthesiologist will place the linear ultrasound transducer obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The anesthesiologist will direct a 22G, 80 mm needle toward the transversus abdominis fascia and inject 25 mL of 0.25% bupivacaine between the rectus abdominis and transversus abdominis muscles along the subcostal line.

Intervention Type: DRUG

External Oblique Intercostal Plane Block

Patients will receive external oblique intercostal block the patient will be in the supine position with their ipsilateral arm abducted, A linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, with the orientation marker directed cranially. The skin will be sterilized, and the probe will be placed over the sixth rib medial to the anterior axillary line in a parasagittal orientation the in-plane technique with a 22G, 80 mm block needle will be used to inject 25 ml of 0.25% bupivacaine into the external oblique intercostal plane.

Intervention Type: DRUG

Control group

Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia.

General anesthesia induction will be performed with fentanyl 1-2 μg/kg, propofol 2-3 mg/kg, and rocuronium 0.6 mg/kg and maintained with sevoflurane.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age (18-65) year.
• Both sexes.
• American Society of Anesthesiologists (ASA) class II and III.
• Cancer patients candidate for open nephrectomy .

Exclusion Criteria

• Patient refusal.
• Skin lesions or infection at the site of proposed needle insertion.
• Cognitive disorders.
• History of psychiatric disorders or drug abuse.
• Patients allergic to medication used.
• ASA class IV.
• Coagulopathy.
• Body mass index (BMI) more than 35.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdelbaset Mostafa

Specialist of Anesthesia, Surgical Intensive Care & Pain Relief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed A Abdelbaset, Master

Role: CONTACT

ahmedabdelbaset500@gmail.com

00201144329865

Facility Contacts

Ahmed A Abdelbaset, Master

Role: primary

ahmedabdelbaset500@gmail.com

00201144329865

Other Identifiers

AP2407-201-013

Identifier Type: -

Identifier Source: org_study_id