Effect of Injection Duration of Fascial Plane Blocks on Block Success

ConditionNerve Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBursa Yuksek Ihtisas Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Laparoscopic cholecystectomy surgery

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

Disqualifiers

Uncontrolled Arterial Hypertension

Uncontrolled Diabetes Mellitus,

Mental retardation

Antidepressant use

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: ConventionalActive comparator 1 intervention
Group B: One-minute injectionActive comparator 1 intervention
Group C: Two-minute injectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

sensory block distribution

The distribution of sensory block will be evaluated using pinprick and cold tests at 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.

Time frame
Postoperative 24 hours

Secondary outcomes

1

NRS

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"

Time frame
Postoperative 24 hours
2

tramadol consumption

Time frame
Postoperative 24 hours]
3

Pressure values

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

Time frame
During the procedure

Other outcomes

Sponsors and contacts

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