Diaphragm; RelaxationNCT06230289
Effect of Transversus Abdominis Plane Block on Diaphragm Thickness
A study testing Transabdominal plane block in people with Diaphragm; Relaxation, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hypothesis: Postoperative pain, by preventing effective diaphragmatic contraction, hinders deep inspiration and expiration. Inspiratory and expiratory levels can be assessed by measuring diaphragm thickness using ultrasound.Diaphragm thickness[DT] measured at the end of inspiration and expiration will differ between… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diaphragm; Relaxation
- What is being tested?
- Transabdominal plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 30 Jun 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent;
- 18-65 years old;
- ASA Physical Status 1-2;
- Scheduled for elective kolesistektomi.
Who cannot join
- ≤18, ≥65 years old;
- Any contraindications nerve blocks;
- VKİ>35 kg/m2;
- Bleeding diathesis;
- Switching to open surgery;
- Language barrier;
Show all 9Show fewer
- Having undergone upper abdominal surgery previously;
- Severe kind of chronic lung ilness;
- Contraindication or allergy to planned drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 4 Point TAP Block on Diaphragm Thickness in Patients Undergoing Laparoscopic Cholecystectomy
Hypothesis: Postoperative pain, by preventing effective diaphragmatic contraction, hinders deep inspiration and expiration. Inspiratory and expiratory levels can be assessed by measuring diaphragm thickness using ultrasound.Diaphragm thickness[DT] measured at the end of inspiration and expiration will differ between patients who undergo Transversus Abdominis Plane Block[TAP] block using the 4-point technique and those who do not. It is anticipated that in patients who receive the block, diaphragm thickness will be greater, serving as an indicator of
Read the detailed description
Postoperative pain is among the main reasons for the decrease in respiratory function after upper abdominal surgery. Numerous studies have investigated the relationship between pain and respiratory function in abdominal surgeries. While the classic TAP block is used to relieve lower abdominal pain [Th10-Th12] after surgery, it may be insufficient in relieving pain in the upper abdominal wall [Th6-Th9]. The 4-point TAPb technique is employed to address the pain in this region. Ultrasound allows for non-invasive assessment of changes in diaphragm thickness along with changes in lung volume, and evaluating diaphragm mass and contraction is highly useful in diagnosing respiratory diseases. Previous studies have explored changes in diaphragm thickness and the relationship between total lung capacity [TLC], functional residual capacity [FRC], residual volume [RV] and diaphragm function. However, changes in diaphragm function due to pain prevention in patients undergoing '4-point' TAPb are not well understood. It is aimed to investigate the impact of the 4-point TAP block on the diaphragm in patients undergoing laparoscopic cholecystectomy under general anesthesia. The primary objective of this study is to use ultrasound to examine the effect of the four-point TAP block, administered for analgesia after laparoscopic cholecystectomy, on diaphragm thickness. The secondary objective is to assess the impact of the four-point TAP block on pain and the quality of patient recovery.
- Conditions
- Diaphragm; Relaxation
- Being tested
- Transabdominal plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal plane blockProcedure or surgery
Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group B will receive a four-point TAP block, while no interventional procedures will be performed on patients in Group C.
| Study group | Role | What they receive |
|---|---|---|
| Group B: Transabdominal plane block group | Active comparator | Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group B will receive a four-point TAP block. Receives: Procedure: Transabdominal plane block |
| Group C: Control group with multi-modal analgesia | No intervention | Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group C which will be performed no interventional procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragma thickness as milimeter
Measurement of Diaphragm Thickness: Patients will be placed in a supine position with the head elevated 30 degrees, and high-frequency linear probe ultrasound (DC-60 Diagnostic Ultrasound, Shenzhen Mindray, China) will be used to visualize the diaphragm in its characteristic three-layered appearance above the anterior axillary line at the aponeurosis region (lung-pleura). The hypoechoic (dark) muscle tissue between the two hyperechoic (bright) lines of pleural and peritoneal fascia will be imaged, and the thickness will be measured and recorded.
Measured: Preoperative measurement of DT and postoperative measurement of DT(5. minutes and 30. minutes)
Secondary outcomes (3)
Visual Analog Scale (from 1 to 10)
Secondary outcome measures will include preoperative and postoperative assessments at 5 minutes, 30 minutes, 2 hours, 8 hours, and 24 hours, using the Visual Analog Scale (VAS) to evaluate pain for both resting and movement (0-10, 0 = no pain, 10 = the most severe pain).
Measured: VAS assessment preoperatively and postoperatively at 5 minutes, 30 minutes, 2 hours, 8 hours, and 24 hours.
Opioid consumption as miligram per day
Secondary outcome measures include preoperative, 5 minutes post-extubation, 30 minutes post-extubation, and 2, 8, and 24 hours postoperatively assessments of total tramadol consumption, the number of patients requiring postoperative rescue analgesia, nausea, vomiting.
Measured: 2, 8, and 24 hours postoperatively assessments
Quality of Recovery-15T score (from 0 to150)
Secondary outcome measures include 24 hours postoperatively assessments of the patient recovery score evaluated with QoR-15T will also be recorded. Results: The QoR-15 scores for Excellent: 136-150, Good:122-135, Moderate:90-121, Poor recovery: 0-89.
Measured: 24 hours postoperatively assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start15 Dec 2023
- Primary completion15 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm; RelaxationStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuran Akıncı Ekinci, Konya City Hospital
- Investigators
- Nuran Akıncı, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230289
- Sponsor's protocol ID
- DiaTap
- Status last verified
- Jul 2024
- First submitted
- 21 Dec 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After performing the study, we might share all info with the system.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4 Point TAP Block on Diaphragm Thickness in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06230289
- Acronym / sponsor ID
- DiaTap
- Conditions
- Diaphragm; Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 30 Jan 2024 (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.
Hypothesis: Postoperative pain, by preventing effective diaphragmatic contraction, hinders deep inspiration and expiration. Inspiratory and expiratory levels can be assessed by measuring diaphragm thickness using ultrasound.Diaphragm thickness[DT] measured at the end of inspiration and expiration will differ between patients who undergo Transversus Abdominis Plane Block[TAP] block using the 4-point technique and those who do not. It is anticipated that in patients who receive the block, diaphragm thickness will be greater, serving as an indicator of
Detailed description
Postoperative pain is among the main reasons for the decrease in respiratory function after upper abdominal surgery. Numerous studies have investigated the relationship between pain and respiratory function in abdominal surgeries. While the classic TAP block is used to relieve lower abdominal pain [Th10-Th12] after surgery, it may be insufficient in relieving pain in the upper abdominal wall [Th6-Th9]. The 4-point TAPb technique is employed to address the pain in this region. Ultrasound allows for non-invasive assessment of changes in diaphragm thickness along with changes in lung volume, and evaluating diaphragm mass and contraction is highly useful in diagnosing respiratory diseases. Previous studies have explored changes in diaphragm thickness and the relationship between total lung capacity [TLC], functional residual capacity [FRC], residual volume [RV] and diaphragm function. However, changes in diaphragm function due to pain prevention in patients undergoing '4-point' TAPb are not well understood. It is aimed to investigate the impact of the 4-point TAP block on the diaphragm in patients undergoing laparoscopic cholecystectomy under general anesthesia. The primary objective of this study is to use ultrasound to examine the effect of the four-point TAP block, administered for analgesia after laparoscopic cholecystectomy, on diaphragm thickness. The secondary objective is to assess the impact of the four-point TAP block on pain and the quality of patient recovery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B: Transabdominal plane block group | Active comparator | Procedure: Transabdominal plane blockPatients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group B will receive a four-point TAP block. |
| Group C: Control group with multi-modal analgesia | No intervention | –Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group C which will be performed no interventional procedures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent;
- 18-65 years old;
- ASA Physical Status 1-2;
- Scheduled for elective kolesistektomi.
Key exclusion criteria (9 listed)
- ≤18, ≥65 years old;
- Any contraindications nerve blocks;
- VKİ>35 kg/m2;
- Bleeding diathesis;
- Switching to open surgery;
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 |
|---|---|---|
| Transabdominal plane blockPatients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group B will receive a four-point TAP block, while no interventional procedures will be performed on patients in Group C. | Procedure or surgery | Group B: Transabdominal plane block group |
Primary outcome
Diaphragma thickness as milimeter
Time frame: Preoperative measurement of DT and postoperative measurement of DT(5. minutes and 30. minutes)
Measurement of Diaphragm Thickness: Patients will be placed in a supine position with the head elevated 30 degrees, and high-frequency linear probe ultrasound (DC-60 Diagnostic Ultrasound, Shenzhen Mindray, China) will be used to visualize the diaphragm in its characteristic three-layered appearance above the anterior axillary line at the aponeurosis region (lung-pleura). The hypoechoic (dark) muscle tissue between the two hyperechoic (bright) lines of pleural and peritoneal fascia will be imaged, and the thickness will be measured and recorded.
3 secondary outcomes
Visual Analog Scale (from 1 to 10)
Time frame: VAS assessment preoperatively and postoperatively at 5 minutes, 30 minutes, 2 hours, 8 hours, and 24 hours.
Opioid consumption as miligram per day
Time frame: 2, 8, and 24 hours postoperatively assessments
Quality of Recovery-15T score (from 0 to150)
Time frame: 24 hours postoperatively assessments
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 5 Jul 2024.
- Individual participant dataSharing planned: Yes. After performing the study, we might share all info with the system.
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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.
Nuran Akıncı, MD principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal plane block in people with Diaphragm; Relaxation, run by Konya City 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 4 inclusion and 9 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 5 Jul 2024. 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?
Diaphragma thickness as milimeter (time frame: Preoperative measurement of DT and postoperative measurement of DT(5. minutes and 30. minutes)). 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 5 Jul 2024.