Pain, PostoperativeNCT06768385
Comparison of Two Regional Blocks For Pain Treatment After Laparoscopic Cholecystectomy
A study testing Transversus abdominis plane (TAP) block and thoracoabdominal nerve blockage with perichondrial approach (TAPA) block in people with Pain, Postoperative, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
In laparoscopic cholecystectomies, ultrasound-guided interfascial plane blocks are commonly used for postoperative analgesia. The aim of our study was to compare the postoperative analgesic efficacy of thoracoabdominal nerve block with the perichondral approach (TAPA) with transversus abdominis plane (TAP) block in… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Transversus abdominis plane (TAP) block and thoracoabdominal nerve blockage with perichondrial approach (TAPA) block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Aug 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Patients classified as I-II-III by the American Society of Anesthesiologists (ASA) and aged between 20 and 70 years were included in the study
Exclusion Criteria:Patients were excluded if they were younger than 20 years, older than 70 years, had ASA physical status classification IV, were pregnant or had a body mass index (BMI) ≥ 35 kg m-2, had a skin infection at the needle puncture site, had a history of previous abdominal surgery or trauma, were known to be allergic to any of the study drugs, had used any analgesic within 24 hours before surgery, had a history of chronic opioid use, alcohol or drug use, were receiving antithrombotic therapy, and had abnormal coagulation parameters.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Sultan Abdulhamid Han
Istanbul, Asia, 34668
About this study
Official title: Comparison of The Efficacy of TAP and TAPA (Thoracoabdominal Nerve Blockage With Perichondrial Approach) Blocks For Pain Treatment After Laparoscopic Cholecystectomy
In laparoscopic cholecystectomies, ultrasound-guided interfascial plane blocks are commonly used for postoperative analgesia. The aim of our study was to compare the postoperative analgesic efficacy of thoracoabdominal nerve block with the perichondral approach (TAPA) with transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy (LC) is one of the most frequently performed surgical operations and the postoperative hospital stay is short (1). Although there is less postoperative pain in laparoscopic surgeries than in open surgeries, severe pain is a common complaint, especially in the first 24 hours. Therefore, various modalities have been tried to reduce postoperative pain (2).
In recent years, the effectiveness of ultrasound-guided interfascial plane blocks has come to the fore in the field of regional anaesthesia and pain management. There has always been a search for a regional anaesthesia method that provides effective analgesia of the anterolateral part of the upper abdomen. In addition to anterolateral blocks, such as pectoralis nerve block (PECS) and serratus intercostal plane block (SIBP), other posterior blocks like quadratus lumborum blocks and erector spinus plane blocks have been used for this purpose. TAP block is the application of local anaesthetic agents into the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen. This procedure, in which the anterior branches of the 7th-12th thoracic intercostal and first lumbar (L1) nerves are blocked, is frequently used to provide pain control after operations involving the abdominal and inguinal regions (3,4).
Recently introduced thoracoabdominal nerve blockage with perichondrial approach (TAPA) has been reported to provide sensory blockade between midaxillary line and midabdominal/sternum in dermatomes between T5-T12 (5,6). In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium. In this way the anterior and lateral cutaneous branches of the intercostal nerves are blocked. In light of this information, our hypothesis is that the analgesic effect will be greater in TAPA block since the lateral branches of the intercostal nerves are also affected.
The aim of our study is to compare the postoperative analgesic efficacies of TAP and TAPA blocks to be applied to patients undergoing laparoscopic cholecystectomy.
- Conditions
- Pain, Postoperative
- Being tested
- Transversus abdominis plane (TAP) block, thoracoabdominal nerve blockage with perichondrial approach (TAPA) block
- Keywords
- laparoscopic cholecystectomy, transversus abdominis plane block, thoracoabdominal nerve block with the perichondral approach
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane (TAP) blockProcedure or surgery
: It was performed under USG guidance using 30 ml of 0.25% bupivacaine with an 80 mm insulated peripheral block needle. Local anaesthetic was applied between the upper fascia of the transversus abdominus muscle and the fascia of the internal oblique muscle at the midpoint of the distance between the costal margin and the iliac crest in the midaxillary line under USG imaging guidance.
thoracoabdominal nerve blockage with perichondrial approach (TAPA) blockProcedure or surgery
Under USG guidance, 20 ml of 0.25% bupivacaine was administered between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue at the level of the 9th and 10th ribs (arcus costarum) in the midclavicular line with an 80 mm insulated peripheral block needle. Then, 10 ml of 0.25% bupivacaine was injected into the upper fascia of the costochondral tissue and the lower fascia of the external oblique muscle. The block was performed by following the needle path in the ultrasound image.
| Study group | Role | What they receive |
|---|---|---|
| group T | Active comparator | After general anesthesia induction, TAP block was applied to Group T. TAP block is the application of local anaesthetic agents to the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen. Receives: Procedure: Transversus abdominis plane (TAP) block |
| group P | Active comparator | TAPA block was applied to Group P. In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium. Receives: Procedure: thoracoabdominal nerve blockage with perichondrial approach (TAPA) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesic efficacy
NRS (Numerical Rating Scale) was used for pain monitoring. Patients were informed about the NRS assessment for pain. It was stated that a score of 0 meant no pain and a score of 10 meant the worst pain imaginable. After the first assessment hour when NRS >4 was noted in patients, IV analgesia treatment was started (dexketoprofen 50 mg IV as additional analgesic). If NRS <4 and the patient did not request analgesic, the drug dose was skipped.
Measured: At the postoperative 2nd, 6th, 12th and 24th hours, the patient's request and administrations from the patient-controlled analgesia (PCA) device, total tramadol dose and the first additional analgesic drug if needed, and application times were recorded.
Secondary outcomes (1)
presence of nausea-vomiting
presence of nausea-vomiting recorded at the postoperative 2nd, 6th, 12th and 24th hours
Measured: the postoperative 2nd, 6th, 12th and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients were randomly allocated to one of two groups using a computer-generated randomized sequence table with an allocation ratio of 1:1 and a block size of two.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yamac, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Dilek M Yamac, Principal investigator, Sultan Abdülhamid Han education and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768385
- Sponsor's protocol ID
- SBU-ANESTHESİA-DMY-02
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 10 Jan 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Efficacy of TAP and TAPA (Thoracoabdominal Nerve Blockage With Perichondrial Approach) Blocks For Pain Treatment After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06768385
- Acronym / sponsor ID
- SBU-ANESTHESİA-DMY-02
- Conditions
- Pain, Postoperative
- Keywords
- laparoscopic cholecystectomy, transversus abdominis plane block, thoracoabdominal nerve block with the perichondral approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 10 Jan 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.
In laparoscopic cholecystectomies, ultrasound-guided interfascial plane blocks are commonly used for postoperative analgesia. The aim of our study was to compare the postoperative analgesic efficacy of thoracoabdominal nerve block with the perichondral approach (TAPA) with transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy (LC) is one of the most frequently performed surgical operations and the postoperative hospital stay is short (1). Although there is less postoperative pain in laparoscopic surgeries than in open surgeries, severe pain is a common complaint, especially in the first 24 hours. Therefore, various modalities have been tried to reduce postoperative pain (2).
In recent years, the effectiveness of ultrasound-guided interfascial plane blocks has come to the fore in the field of regional anaesthesia and pain management. There has always been a search for a regional anaesthesia method that provides effective analgesia of the anterolateral part of the upper abdomen. In addition to anterolateral blocks, such as pectoralis nerve block (PECS) and serratus intercostal plane block (SIBP), other posterior blocks like quadratus lumborum blocks and erector spinus plane blocks have been used for this purpose. TAP block is the application of local anaesthetic agents into the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen. This procedure, in which the anterior branches of the 7th-12th thoracic intercostal and first lumbar (L1) nerves are blocked, is frequently used to provide pain control after operations involving the abdominal and inguinal regions (3,4).
Recently introduced thoracoabdominal nerve blockage with perichondrial approach (TAPA) has been reported to provide sensory blockade between midaxillary line and midabdominal/sternum in dermatomes between T5-T12 (5,6). In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium. In this way the anterior and lateral cutaneous branches of the intercostal nerves are blocked. In light of this information, our hypothesis is that the analgesic effect will be greater in TAPA block since the lateral branches of the intercostal nerves are also affected.
The aim of our study is to compare the postoperative analgesic efficacies of TAP and TAPA blocks to be applied to patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients were randomly allocated to one of two groups using a computer-generated randomized sequence table with an allocation ratio of 1:1 and a block size of two.
| Arm | Type | Receives |
|---|---|---|
| group T | Active comparator | Procedure: Transversus abdominis plane (TAP) blockAfter general anesthesia induction, TAP block was applied to Group T. TAP block is the application of local anaesthetic agents to the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen. |
| group P | Active comparator | Procedure: thoracoabdominal nerve blockage with perichondrial approach (TAPA) blockTAPA block was applied to Group P. In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Transversus abdominis plane (TAP) block: It was performed under USG guidance using 30 ml of 0.25% bupivacaine with an 80 mm insulated peripheral block needle. Local anaesthetic was applied between the upper fascia of the transversus abdominus muscle and the fascia of the internal oblique muscle at the midpoint of the distance between the costal margin and the iliac crest in the midaxillary line under USG imaging guidance. | Procedure or surgery | group T |
| thoracoabdominal nerve blockage with perichondrial approach (TAPA) blockUnder USG guidance, 20 ml of 0.25% bupivacaine was administered between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue at the level of the 9th and 10th ribs (arcus costarum) in the midclavicular line with an 80 mm insulated peripheral block needle. Then, 10 ml of 0.25% bupivacaine was injected into the upper fascia of the costochondral tissue and the lower fascia of the external oblique muscle. The block was performed by following the needle path in the ultrasound image. | Procedure or surgery | group P |
Primary outcome
postoperative analgesic efficacy
Time frame: At the postoperative 2nd, 6th, 12th and 24th hours, the patient's request and administrations from the patient-controlled analgesia (PCA) device, total tramadol dose and the first additional analgesic drug if needed, and application times were recorded.
NRS (Numerical Rating Scale) was used for pain monitoring. Patients were informed about the NRS assessment for pain. It was stated that a score of 0 meant no pain and a score of 10 meant the worst pain imaginable. After the first assessment hour when NRS >4 was noted in patients, IV analgesia treatment was started (dexketoprofen 50 mg IV as additional analgesic). If NRS <4 and the patient did not request analgesic, the drug dose was skipped.
1 secondary outcome
presence of nausea-vomiting
Time frame: the postoperative 2nd, 6th, 12th and 24th 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 10 Jan 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.
Dilek M Yamac principal investigator
Sultan Abdülhamid Han education and research 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 Transversus abdominis plane (TAP) block and thoracoabdominal nerve blockage with perichondrial approach (TAPA) block in people with Pain, Postoperative, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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?
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 10 Jan 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?
postoperative analgesic efficacy (time frame: At the postoperative 2nd, 6th, 12th and 24th hours, the patient's request and administrations from the patient-controlled analgesia (PCA) device, total tramadol dose and the first additional analgesic drug if needed, and application times were recorded.). 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 10 Jan 2025.