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NCT Number: NCT07096765

Effect of Injection Duration of Fascial Plane Blocks on Block Success

This prospective observational study aims to evaluate the impact of injection duration during fascial plane blocks on block success and analgesic efficacy in patients undergoing laparoscopic cholecystectomy. The hypothesis is that shorter injection durations increase injection pressure, potentially limiting local anesthetic spread, while longer durations facilitate broader anesthetic distribution.

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Key information

Conditions

Nerve Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

About this study

Fascial plane blocks involve injecting local anesthetics between two anatomical fascial layers, with analgesia achieved by anesthetic diffusion through the fascial plane. However, anesthetic spread may vary significantly based on injection technique, speed, and pressure. This study hypothesizes that injection duration directly influences injection pressure, local anesthetic distribution, and consequently, the extent of sensory blockade and analgesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Laparoscopic cholecystectomy surgery
  • Patients with ASA (American Society of Anaesthetists) scores I and III will be included.

Exclusion criteria

  • Uncontrolled Arterial Hypertension
  • Uncontrolled Diabetes Mellitus,
  • Mental retardation
  • Antidepressant use
  • Metabolic disorders
  • Bleeding diathesis
  • Patients with a body mass index above 30

Treatment and study plan

Group O

Drug

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg ,

%0.25 bupivacaine) will be performed Drug: Tramadol 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Group T

Drug

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg ,

%0.25 bupivacaine) will be performed Drug: Tramadol 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Group C

Drug

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg ,

%0.25 bupivacaine) will be performed Drug: Tramadol 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Primary outcomes

  1. sensory block distribution

    Time frame: Postoperative 24 hours

    The distribution of sensory block will be evaluated using pinprick and cold tests at 2, 6, 12 and 24 hours after surgery.

    With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.

Secondary outcomes

  1. NRS

    Time frame: Postoperative 24 hours

    The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  2. tramadol consumption

    Time frame: Postoperative 24 hours]

  3. Pressure values

    Time frame: During the procedure

    Pressure values (mm/hg) measured using the infusion device during block application.

Study contacts

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

Korgün Ökmen, PhD.

CONTACT

[email protected]

05057081021

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Effect of Injection Duration of Fascial Plane Blocks on Block Success and Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Jul 31, 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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