Nerve BlockNCT07096765
Effect of Injection Duration of Fascial Plane Blocks on Block Success
A study testing Group O, Group T and Group C in people with Nerve Block, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Block
- What is being tested?
- Group O, Group T and Group C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic cholecystectomy surgery
- Patients with ASA (American Society of Anaesthetists) scores I and III will be included.
Who cannot join
- Uncontrolled Arterial Hypertension
- Uncontrolled Diabetes Mellitus,
- Mental retardation
- Antidepressant use
- Metabolic disorders
- Bleeding diathesis
- Patients with a body mass index above 30
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
Korgün Ökmen, Assoc.Phd., 05057081021, korgunokmen@gmail.com
About this study
Official title: Effect of Injection Duration of Fascial Plane Blocks on Block Success and Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
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.
Read the detailed description
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.
- Conditions
- Nerve Block
- Being tested
- Group O, Group T, Group C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ODrug
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 TDrug
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 CDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | During the fascia block application, the injection will be administered using the conventional method without any specific time limit. Receives: Drug: Group C |
| One-minute injection | Active comparator | During the fascia block application, the injection will be administered within 1 minute. Receives: Drug: Group O |
| Two-minute injection | Active comparator | During the fascia block application, the injection will be administered within 2 minutes. Receives: Drug: Group T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 24 hours
Secondary outcomes (3)
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"
Measured: Postoperative 24 hours
tramadol consumption
Measured: Postoperative 24 hours]
Pressure values
Pressure values (mm/hg) measured using the infusion device during block application.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096765
- Sponsor's protocol ID
- 2024-ТВЕK 2025/07-05
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Injection Duration of Fascial Plane Blocks on Block Success and Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07096765
- Acronym / sponsor ID
- 2024-ТВЕK 2025/07-05
- Conditions
- Nerve Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Drug: Group CDuring the fascia block application, the injection will be administered using the conventional method without any specific time limit. |
| One-minute injection | Active comparator | Drug: Group ODuring the fascia block application, the injection will be administered within 1 minute. |
| Two-minute injection | Active comparator | Drug: Group TDuring the fascia block application, the injection will be administered within 2 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Laparoscopic cholecystectomy surgery
- Patients with ASA (American Society of Anaesthetists) scores I and III will be included.
Key exclusion criteria (7 listed)
- Uncontrolled Arterial Hypertension
- Uncontrolled Diabetes Mellitus,
- Mental retardation
- Antidepressant use
- Metabolic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group OUltrasound 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. | Drug | One-minute injection |
| Group TUltrasound 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. | Drug | Two-minute injection |
| Group CUltrasound 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. | Drug | Conventional |
Primary outcome
sensory block distribution
Time frame: Postoperative 24 hours
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.
3 secondary outcomes
NRS
Time frame: Postoperative 24 hours
tramadol consumption
Time frame: Postoperative 24 hours]
Pressure values
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group O, Group T and Group C in people with Nerve Block, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Korgün Ökmen, PhD. (05057081021, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory block distribution (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.