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

NCT06584695 | Recruiting

• 1 other identifier: AP2407-201-013
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  Degree of pain by Numerical rating scale (NRS)score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable"). scores will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery, when the (NRS) was \> 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.

  24 hours after surgery

Secondary Outcomes (6)

• Mean arterial pressure

  Till the end of surgery (up to 2hours)

• Heart rate

  Till the end of surgery (up to 2hours)

• Opioids consumption

  24 hours after surgery

• Morphine consumption

  24 hours after surgery.

• Time to rescue analgesia.

  24 hours after surgery

Study Arms (3)

Transversus abdominis plane group

EXPERIMENTAL

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

Drug: Transversus abdominis plane block

External oblique intercostal group

EXPERIMENTAL

Patients will receive unilateral ultrasound-guided external oblique intercostal block

Drug: External Oblique Intercostal Plane Block

Control group

ACTIVE COMPARATOR

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

Drug: Control group

Interventions

Transversus abdominis plane block 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.

Transversus abdominis plane group

External Oblique Intercostal Plane Block 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.

External oblique intercostal group

Control group 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.

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Ahmed A Abdelbaset, Master

CONTACT

00201144329865; ahmedabdelbaset500@gmail.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: Specialist of Anesthesia, Surgical Intensive Care & Pain Relief

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 5, 2024
• Study Start: September 5, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)