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NCT Number: NCT05272280

US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy

To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University hospital

Asyut, Assiut, Asyut Governorate, Egypt,, Egypt

Location status: Recruiting

Location contact

Magdy M Mahdy, Lecturer

CONTACT

[email protected]

01096502058

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
  • patients with the American Society of Anesthesiologists (ASA) physical status I/II,
  • Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion criteria

  • Allergy to local anaesthetics,
  • Infection at the site of injection,
  • Coagulopathy,
  • Chronic pain syndromes,
  • Prolonged opioid medication,
  • Patients who received any analgesic 24 h before surgery.

Treatment and study plan

External oblique intercostal (EOI) block

Other

A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.

Erector Spinae Plane Block (ESPB)

Other

A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.

Primary outcomes

  1. Nalbuphine consumption in mg equivalent to morphine dose.

    Time frame: 24 hours postoperatively

    mg

Secondary outcomes

  1. Numerical Rating Scale (NRS) at rest and when coughing

    Time frame: at 1, 2,4 , 8, 16 and 24 hours postoperatively

    11-point scale where 0=no pain and 10=worst pain

  2. Analgesic drug consumption other than nalbuphine

    Time frame: 24 hours postoperatively

    in mg

  3. Heart Rate

    Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery

    beats /min

  4. Mean Arterial Pressure

    Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery

    mmHg

  5. Incidence of Postoperative nausea & vomiting (PONV)

    Time frame: 24 hours postoperatively

    Number of patients developing PONV

  6. Shoulder pain

    Time frame: 24 hours postoperatively

    Number of patients developing Shoulder pain

Study contacts

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

Amr M.A. Thabet, MD

CONTACT

[email protected]

01068924262

Magdy M mahdy, MD

CONTACT

[email protected]

0109 650 2058

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ultrasound Guided External Oblique Intercostal (EOI) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia in Laparoscopic Cholecystectomy

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2022
Registry last updated
Aug 2, 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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