Pain, PostoperativeNCT06144307
Effects of Fascial Plan Blocks on Pulmonary Functions
An observational study of Pain, Postoperative and Respiratory Function Loss, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
In addition to the traumatic effect of the operation, the effort to immobilize the auxiliary respiratory muscles due to pain causes a decrease in postoperative respiratory function (especially in thoracic and upper abdominal surgeries). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Respiratory Function Loss
- What is being tested?
- plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 31 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients who will undergo cholecystectomy between the ages of 18-65
Who may be able to join
- 18-65 years old
- ASA I-II-III risk group
- Patients whose consent was obtained with an informed consent form
- She will undergo a cholecystectomy operation
- Patients to be cooperative for SFT test
Who cannot join
- <18 years and >65 years
- ASA ≥ IV
- Pulmonary function test below 50% of the expected value
- Known diaphragm paralysis
- Body mass index >30
- Myocardial infarction within 1 month
Show all 12Show fewer
- Dementia or confusion
- Lack of cooperation
- People with respiratory diseases
- Congestive heart failure
- Unstable hypertension
- Thoracoabdominal surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Faculty of Medicine
Kozlu, Zonguldak Province, 67600
About this study
Official title: Effects of External Oblique Fascial Plan Block and Subcostal Transversus Abdominis Plan Block on Postoperative Pulmonary Functions
In addition to the traumatic effect of the operation, the effort to immobilize the auxiliary respiratory muscles due to pain causes a decrease in postoperative respiratory function (especially in thoracic and upper abdominal surgeries). In addition, superficial and tachypneic breathing caused by the inability of the patient to take deep breaths with pain leads to closure of small airways and increase in intrapulmonary shunts, resulting in hypoxia. Postoperative pain management is important not only to prevent pain but also to reduce pulmonary complications that may occur due to changes in lung function and to reduce mortality and morbidity by controlling the stress response. Pain after nausea and vomiting is the most common reason for hospitalization after laparoscopic surgery.
Although pain in laparoscopic cholecystectomy (LC) has many components including incisional, visceral and reflected, the primary source of pain is incisional pain. A multimodal analgesic approach (NSAII, paracetamol, opioids, local infiltration, facial plane blocks and paravertebral and periparavertebral blocks) is recommended. Regional anesthesia combined with general anesthesia reduces the stress response associated with surgery and reduces the need for opioid use. Subcostal TAP Block; injection of local anesthetic between the internal oblique and transversus abdominis muscles in the upper quadrant of the anterior abdominal wall blocks the anterior cutaneous branches of the thoracoabdominal nerves. External Oblique Fascial Plane Block (EOIB); blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves. It is performed between the 6th-7th costae. There is a cutaneous sensory block between T6-T9 in the midabdomen and T6-T10 in the anterior axillary line.
The conventional method is the administration of intravenous opioids as a method of postoperative analgesia when the routine block cannot be performed due to a contraindication.
- Conditions
- Pain, Postoperative, Respiratory Function Loss
- Being tested
- plane block
- Keywords
- postoperative pain, plane block, pulmonary function
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plane blockProcedure or surgery
injection of local anesthetic to the myofascial plane
| Study group | Role | What they receive |
|---|---|---|
| External Oblique Fascial Plan Block | Not described Receives: Procedure: plane block | |
| Subcostal Transversus Abdominis Plan Block | Not described Receives: Procedure: plane block | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of plane blocks on postoperative pulmonary function
The effect of pain relief after plane blocks on postoperative pulmonary function
Measured: during the postoperative 24 hours
Secondary outcomes (3)
opioid consumption
need for opioids as a result of pain
Measured: during the postoperative 24 hours
Incidence of nausea and vomiting
Need for nausea and vomiting
Measured: during the postoperative 24 hours
quality of recovery-15
Quality of recovery of patients by survey
Measured: during the postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Dec 2023
- Primary completion30 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Gülhan Köksal, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144307
- Sponsor's protocol ID
- 2023/04-3
- Status last verified
- May 2025
- First submitted
- 16 Nov 2023
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of External Oblique Fascial Plan Block and Subcostal Transversus Abdominis Plan Block on Postoperative Pulmonary Functions
- ClinicalTrials.gov ID
- NCT06144307
- Acronym / sponsor ID
- 2023/04-3
- Conditions
- Pain, Postoperative, Respiratory Function Loss
- Keywords
- postoperative pain, plane block, pulmonary function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Nov 2023 (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.
In addition to the traumatic effect of the operation, the effort to immobilize the auxiliary respiratory muscles due to pain causes a decrease in postoperative respiratory function (especially in thoracic and upper abdominal surgeries). In addition, superficial and tachypneic breathing caused by the inability of the patient to take deep breaths with pain leads to closure of small airways and increase in intrapulmonary shunts, resulting in hypoxia. Postoperative pain management is important not only to prevent pain but also to reduce pulmonary complications that may occur due to changes in lung function and to reduce mortality and morbidity by controlling the stress response. Pain after nausea and vomiting is the most common reason for hospitalization after laparoscopic surgery.
Although pain in laparoscopic cholecystectomy (LC) has many components including incisional, visceral and reflected, the primary source of pain is incisional pain. A multimodal analgesic approach (NSAII, paracetamol, opioids, local infiltration, facial plane blocks and paravertebral and periparavertebral blocks) is recommended. Regional anesthesia combined with general anesthesia reduces the stress response associated with surgery and reduces the need for opioid use. Subcostal TAP Block; injection of local anesthetic between the internal oblique and transversus abdominis muscles in the upper quadrant of the anterior abdominal wall blocks the anterior cutaneous branches of the thoracoabdominal nerves. External Oblique Fascial Plane Block (EOIB); blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves. It is performed between the 6th-7th costae. There is a cutaneous sensory block between T6-T9 in the midabdomen and T6-T10 in the anterior axillary line.
The conventional method is the administration of intravenous opioids as a method of postoperative analgesia when the routine block cannot be performed due to a contraindication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| External Oblique Fascial Plan Block | – | Procedure: plane block |
| Subcostal Transversus Abdominis Plan Block | – | Procedure: plane block |
| Control | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo cholecystectomy between the ages of 18-65
Key inclusion criteria (5 listed)
- 18-65 years old
- ASA I-II-III risk group
- Patients whose consent was obtained with an informed consent form
- She will undergo a cholecystectomy operation
- Patients to be cooperative for SFT test
Key exclusion criteria (12 listed)
- <18 years and >65 years
- ASA ≥ IV
- Pulmonary function test below 50% of the expected value
- Known diaphragm paralysis
- Body mass index >30
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 |
|---|---|---|
| plane blockinjection of local anesthetic to the myofascial plane | Procedure or surgery | External Oblique Fascial Plan Block, Subcostal Transversus Abdominis Plan Block |
Primary outcome
the effect of plane blocks on postoperative pulmonary function
Time frame: during the postoperative 24 hours
The effect of pain relief after plane blocks on postoperative pulmonary function
3 secondary outcomes
opioid consumption
Time frame: during the postoperative 24 hours
Incidence of nausea and vomiting
Time frame: during the postoperative 24 hours
quality of recovery-15
Time frame: during the postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Respiratory Function Loss, run by Zonguldak Bulent Ecevit University 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 28 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of plane blocks on postoperative pulmonary function (time frame: during the 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 28 May 2025.