Effect of Injection Duration of Fascial Plane Blocks on Block Success

NCT07096765 | Not Yet Recruiting

• 1 other identifier: 2024-ТВЕK 2025/07-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

• sensory block distribution

  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.

  Postoperative 24 hours

Secondary Outcomes (3)

• NRS

  Postoperative 24 hours

• tramadol consumption

  Postoperative 24 hours]

• Pressure values

  During the procedure

Study Arms (3)

Conventional

ACTIVE COMPARATOR

During the fascia block application, the injection will be administered using the conventional method without any specific time limit.

Drug: Group C

One-minute injection

ACTIVE COMPARATOR

During the fascia block application, the injection will be administered within 1 minute.

Drug: Group O

Two-minute injection

ACTIVE COMPARATOR

During the fascia block application, the injection will be administered within 2 minutes.

Drug: Group T

Interventions

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.

One-minute injection

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.

Two-minute injection

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.

Conventional

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Interventions

O-antigen, Acinetobacter strain 90; Sensitivity Training Groups

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Korgün Ökmen, PhD.

CONTACT

05057081021; korgunokmen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)