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NCT Number: NCT06584695

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11796, Egypt

Location status: Recruiting

Location contact

Ahmed A Abdelbaset, Master

CONTACT

[email protected]

00201144329865

Asmaa E Khalil, MD

SUB_INVESTIGATOR

Khaled Elsamahy, MD

SUB_INVESTIGATOR

Sayed M Abed, MD

SUB_INVESTIGATOR

Walaa Youssef, MD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Degree of pain

    Time frame: 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 outcomes

  1. Mean arterial pressure

    Time frame: Till the end of surgery (up to 2hours)

    Mean arterial pressure will be recorded intraoperative till the end of surgery.

  2. Heart rate

    Time frame: Till the end of surgery (up to 2hours)

    Heart rate will be recorded intraoperative till the end of surgery.

  3. Opioids consumption

    Time frame: 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.

  4. Morphine consumption

    Time frame: 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.

  5. Time to rescue analgesia.

    Time frame: 24 hours after surgery

    Time to rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

  6. Incidence of complications

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Abdelbaset, Master

CONTACT

[email protected]

00201144329865

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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