External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Nephrectomy

NCT ID: NCT06778707

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-05
• Study Completion Date: 2025-08-20

Brief Summary

The aim of the study is to compare the analgesic efficacy of external oblique intercostal block vs subcostal transversus abdominis plane block in patients undergoing open nephrectomy.

Detailed Description

This randomized controlled double blinded study will be done on 80 patients (40 in each group), patients will be randomly classified by computer generated numbers. Through a sealed opaque envelope technique, a blinded nurse who will not participate in the study or data collection, will read the number contained in the envelope and make group assignments.

All patients will be seen in the anesthesia clinic, optimization of general condition and all required investigations will be done before surgery. Patients will be premedicated with 1.5 mg midazolam and 4 mg granisetron. Basic monitoring will be applied to the patients such as Pulse oximetry (SPO2), Non-invasive blood pressure (NIBP), Electrocardiogram (ECG), Capnogram and temperature probe.

After adequate preoxygenation, induction of general anesthesia will be done through wide bore cannula using 1 mic/kg fentanyl, 1-2 mg/kg titration of propofol, 0.5mg/kg atracurium. Patients were mechanically ventilated using volume-controlled ventilation (VCV) with adjustment of end tidal carbon dioxide (ETCO2) to be 32-35 mmHg, 50% inspired oxygen in air and sevoflurane concentration to be 1MAC. The patients will receive either block before skin incision that will be done 20 minutes after the block. 0.5 mic/kg fentanyl will be injected when heart rate or blood pressure increases more than 20% of baseline. By the end of the surgery, 1gm paracetamol will be administered with fully reversal of muscle relaxants at the end of the surgery.

Group E This group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles.

After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.

Group T Subcostal transversus abdominis plane block will be applied to this group and patients will be supine. A high-frequency linear transducer will be placed directly below and along costal margin. After sterilization of skin, with in-plane technique and from lateral to medial, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.

After extubation, the patients will be transferred to PACU (Post-Anesthesia Care Unit) for monitoring. Numerical rating scale (NRS) will be used for pain assessment while 0 is no pain and 10 is severe agonizing pain. Patients will be given a rescue analgesia of 0.05 mg / kg morphine if NRS ≥ 4 and repeated if needed after 20 minutes. 1 gm paracetamol every 8 h and 30 mg ketorolac (if not contraindicated) every 12 h will be given regularly.

Conditions

Analgesia , Open Renal Surgeries

Study Design

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

Study Groups

group E

This group of patients will receive external oblique intercostal block in supine position. A high-frequency linear transducer will be placed in sagittal plane between the midclavicular and anterior axillary line at the level of the 6 to 8th rib. The pointing mark of the probe will be directed cranially and may be slightly tilted medially for better identification of external oblique muscle and intercostal muscles.

After sterilization of skin and through the in-plane technique directing from cranial to caudal, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.

Group Type: ACTIVE_COMPARATOR

External Oblique Intercostal Block

Intervention Type: PROCEDURE

In group E, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.

group T

Subcostal transversus abdominis plane block will be applied to this group and patients will be supine. A high-frequency linear transducer will be placed directly below and along costal margin. After sterilization of skin, with in-plane technique and from lateral to medial, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.

Group Type: ACTIVE_COMPARATOR

Subcostal Transversus Abdominis Plane Block

Intervention Type: PROCEDURE

In group T, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.

Interventions

External Oblique Intercostal Block

In group E, a needle will be used to pierce the skin, subcutaneous tissue then external oblique muscle to hydrodissect the fascial plane between external oblique muscle and intercostal muscles with 25 ml bupivacaine 0.25 % and 4 mg dexamethasone added to it.

Intervention Type: PROCEDURE

Subcostal Transversus Abdominis Plane Block

In group T, a needle will be used to pierce the skin, subcutaneous tissue then rectus muscle and 25 ml of 0.25 % bupivacaine with 4 mg dexamethasone will be injected between rectus muscle and transversus abdominis muscle.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who will be included in the study age from 21 to 60 years, both male and female, with American Society of Anesthesiologists (ASA) Physical Status Classification System I-III.

Exclusion Criteria

• Any patient refuses to participate, has bleeding or coagulation disorders, hepatic dysfunction, psychiatric diseases, on chronic opioid use, with history of allergy to local anesthetics and has infection at the needle entry point will be excluded.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdel Wahed Ali

Lecturer at anesthesia & surgical ICU & Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed A Abdelwahed, lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University

Tanta, , Egypt

Countries

Egypt

References

1.Bansal P, Sultania N, Mittal T. External oblique intercostal block in open nephrectomy patients-A zenith in analgesia for anterolateral upper abdominal surgeries: A case series. Asian Journal of Medical Sciences. 2024;15(2):264-8.

Reference Type: BACKGROUND

Related Links

https://ajmsjournal.info/index.php/AJMS/article/view/382?articlesBySimilarityPage=15

https://ajmsjournal.info/index.php/AJMS/article/view/382?articlesBySimilarityPage=15

Other Identifiers

36264PR998/12/24

Identifier Type: -

Identifier Source: org_study_id