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RecruitingNCT05272280Updated Aug 2, 2024

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

An interventional study of External oblique intercostal (EOI) block and Erector spinae plane block (ESPB) in Postoperative Pain, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Postoperative Pain

Browse trials for

Keywords

  • Cholecystectomy
  • EOI block
  • ESP block
03

In context

Pain, Postoperative

5,095 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 50 is below the median of 75 across 4,346 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    External oblique intercostal (EOI) block

    Other: External oblique intercostal (EOI) block

  • Active comparator
    Erector spinae plane block (ESPB)

    Other: Erector spinae plane block (ESPB)

Interventions

  • OtherExternal oblique intercostal (EOI) block

    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.

  • OtherErector spinae plane block (ESPB)

    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.

06

What researchers measure

Primary outcomes

  1. Nalbuphine consumption in mg equivalent to morphine dose.

    mg

    Time frame: 24 hours postoperatively

Secondary outcomes

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

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

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

  2. Analgesic drug consumption other than nalbuphine

    in mg

    Time frame: 24 hours postoperatively

  3. Heart Rate

    beats /min

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

  4. Mean Arterial Pressure

    mmHg

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

  5. Incidence of Postoperative nausea & vomiting (PONV)

    Number of patients developing PONV

    Time frame: 24 hours postoperatively

  6. Shoulder pain

    Number of patients developing Shoulder pain

    Time frame: 24 hours postoperatively

07

Study locations

1 of 1 sites recruiting
  • Assiut University hospital
    Assiut, Assiut, Asyut Governorate, Egypt,, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05272280
Lead sponsor
Assiut University
Responsible party
Magdy Mohammed Mahdy Sayed (Doctor, Assiut University) — Principal investigator
First posted
Mar 9, 2022
Start date
May 1, 2022
Primary completion
Jan 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Aug 2, 2024

Study contacts

Magdy M mahdy, MD
Contact
magdymahdy84@yahoo.com
0109 650 2058
Amr M.A. Thabet, MD
Contact
Amrthabet@aun.edu.eg
01068924262

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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