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Completed

NCT Number: NCT06712498

INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK IN PATIENTS UNDERGOING LAPARASCOPIC CHOLESYSTECTOMY OPERATION

Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. The purpose of our study is to compare parameters such as intraoperative hemodynamics, postoperative analgesic requirement, and patient satisfaction between patients undergoing External Oblique Intercostal Plane Block (EOIB) with those who did not receive EOIB, which has few studies conducted on it.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged between 18-65
  • and with ASA1-2 were included.

Exclusion criteria

• Patients younger than 18 years of age and older than 65 years of age

  • Patients allergic to local anesthetics
  • Patients with opioid and alcohol addiction
  • Patients with perioperative signs of acute cholecystitis
  • Patients with contraindications for laparoscopic surgery
  • Cases with ASA III-IV were not included in the study.

Treatment and study plan

External Oblique Intercostal Plane Block

Procedure

After endotracheal intubation, a 22-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally).

Control group

Drug

No intervention

Primary outcomes

  1. Numeric Rating Scale

    Time frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

    They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome

  2. Visual Analogue Scale

    Time frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

    The Visual Analogue Scale (VAS) is a subjective measure of pain. It consists of a 10cm line with two endpoints representing 'no pain' and 'worst pain imaginable'. Patients are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.

Secondary outcomes

  1. Riker Sedation Agitation Scale

    Time frame: Immediately after extubation

    7 Dangerous Agitation ... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.

  2. Patient satisfaction score

    Time frame: at the 24th postoperative hour

    Patients' satisfaction with the quality of pain management will be evaluated on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = highly dissatisfied; 3 = medium; 4 = very satisfactory; 5 = very satisfactory

  3. Postoperative vomiting and nausea

    Time frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours

    Postoperative vomiting and nausea: yes or no

  4. Opioid use

    Time frame: Postoperative 24 hours

    Tramadol use

  5. Mean Arter Pressure

    Time frame: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours

    mm/hg

  6. Heart Rate

    Time frame: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours

    beats/minute

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2024
Registry last updated
Nov 24, 2025

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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