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

Not Applicable

Not yet recruiting

• Conditions: Analgesic Efficacy; External Oblique Intercostal Block; Subcostal Transversus Abdominis Plane Block; Open; Nephrectomy
• Interventions: Drug: Transversus abdominis plane block; Drug: External Oblique Intercostal Plane Block; Drug: Control group

• Registration Number: NCT06584695
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2024-08-31
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05
• Study Start: 2024-09-10
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus abdominis plane group	Transversus abdominis plane block	patients will receive unilateral ultrasound-guided oblique subcostal transversus abdominis plane block block
External oblique intercostal group	External Oblique Intercostal Plane Block	Patients will receive unilateral ultrasound-guided external oblique intercostal block
Control group	Control group	Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia.

Primary Outcome Measures

Name	Time	Method
Degree of pain	24 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	Till the end of surgery (up to 2hours)	Mean arterial pressure will be recorded intraoperative till the end of surgery.
Heart rate	Till the end of surgery (up to 2hours)	Heart rate will be recorded intraoperative till the end of surgery.
Opioids consumption	24 hours after surgery	Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable"). 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.
Morphine consumption	24 hours after surgery.	When the numeric rating scale (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.; Each patient will be instructed about postoperative pain assessment with the NRS score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable").NRS will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery.
Time to rescue analgesia.	24 hours after surgery	Time to rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Incidence of complications	24 hours after surgery	Incidence of complications will be recorded such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt