Pain, PostoperativeTAPANCT05215691
Outcomes of Thoracoabdominal Nerve Block Through Perichondrial Approach* on Postoperative Cognitive Functions
An observational study of Pain, Postoperative and Cognition, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It was planned to compare the opioid consumption and cognitive functions in the postoperative period of patients who received TAPA block for postoperative analgesia and patients who did not prefer the block and who preferred intravenous patient-controlled analgesia (PCA) with opioids. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative, Cognition
- What is being tested?
- Group I: TAPA block and Group II: IV Morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 10 Sep 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who will undergo major abdominoplasty, ASA II and ASA III, over the age of 18, under the age of 85 in the Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital.
Who may be able to join
- patients who will undergo major abdominoplasty,
- over the age of 18,
- under the age of 85,
- patients who has ASA (American Society of Anesthesiologists) II and ASA III criteria
Who cannot join
- younger than 18 years old, over 85 years old,
- Having a history of cerebrovascular disease
- Having surgery other than oncological surgery
- having coagulation disorder
- being illiterate
- having visual and auditory problems
Show all 11Show fewer
- Inability to cooperate with cognitive function test
- having an emergency surgery
- Those who are not able to read and sign the consent form
- Patients deemed unsuitable by the researcher
- Patients who do not want to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06200
About this study
Official title: TAPA Block Versus Conventional Analgesia Methods on Cognitive Functions and Postoperative Opioid Consumption in Major Abdominal Surgery
It was planned to compare the opioid consumption and cognitive functions in the postoperative period of patients who received TAPA block for postoperative analgesia and patients who did not prefer the block and who preferred intravenous patient-controlled analgesia (PCA) with opioids. Both the surgery applied and the drugs used in anesthesia can cause changes in cognitive functions by affecting the inflammatory process. It is thought that if the patients' pain can be relieved sufficiently in the postoperative period with TAPA block, the consumption of opioids used will be less and their cognitive functions will be less affected.
Read the detailed description
Postoperative pain management after major surgical operations is a very important issue. Features such as waking up without pain, early recovery from anesthesia, not suppressing respiration by the drugs used for postoperative pain treatment, not delaying recovery from anesthesia, not having unwanted side effects, and not delaying discharge from the intensive care unit are the desired features of postoperative pain management. A wide variety of drug therapy modalities are available for this purpose. However, peripheral nerve blocks are widely used to minimize undesirable effects of drug therapy. TAP block (trans abdominal plane block) has been used for this purpose since ancient times. TAPA block (thoracoabdominal block with perichondral approach) is a newly developed plane block and was developed to obtain higher level block with a single injection. In this study, we planned to compare the recovery times from anesthesia, postoperative pain scores, opioid consumption, and cognitive functions of patients who underwent TAPA block for postoperative pain treatment and patients who were not preferred to TAPA block and were planned for pain treatment with conventional methods, whether these treatments affected or not.
Neuropsychological dysfunction is a frequently encountered condition after surgery. Postoperative cognitive dysfunction can affect various cognitive functions such as attention, memory, and information processing speed. The most notable symptoms are memory deficits and decreased ability to cope with intellectual difficulties. It has been stated that postoperative cognitive dysfunction depends on advanced age, duration of anesthesia, development of complications, pre-existing cognitive disorders, and education level.
In a study, it was reported that the incidence of postoperative cognitive dysfunction in patients aged around 60 years who underwent major noncardiac surgery was 25.8% after 1 week and 9.9% after 3 months.
In the literature, it has been mentioned that inflammatory processes that occur as a result of surgical trauma and subsequent complications play a role in cognitive dysfunction. Normal cognitive functions can be maintained in low-level inflammatory processes, while very high-level proinflammatory factors can significantly affect cognitive functions.
Traditional lateral TAP block is performed on the midaxillary line between the iliac crest and subcostal. With this approach, with cadaveric dye injection, T11 was shown to be maintained and T12 was maintained 100% time, L1 93% time and T10 50% time. The lateral TAP block reached a dermatome high enough to benefit the patient after open cholecystectomy.
The TAPA block is performed at the rib margin where the 9th and 10th ribs meet. A linear transducer is placed at the costochondral angle in the sagittal plane. It is carried out by injecting 20 ml of drug between the upper and lower surface of the chondrium. The authors state that TAPA block provides analgesia to T5-T12. They hypothesize that the TAPA block numbs both the lateral cutaneous branch and the anterior region.
Although the standardized mini-mental test is not a definitive diagnostic test, it is used by clinicians as an auxiliary test to measure the degree of cognitive deterioration of patients.
We planned this study to compare the recovery times from anesthesia, postoperative pain scores, opioid consumption, and cognitive functions of patients who underwent TAPA block for postoperative pain management and patients who were not preferred TAPA block and were planned for pain treatment with conventional methods, whether these treatments were affected or not.
- Conditions
- Pain, Postoperative, Cognition
- Being tested
- Group I: TAPA block, Group II: IV Morphine
- Keywords
- TAPA block, opioid consumption, cognitive functions
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I: TAPA blockProcedure or surgery
Also called thoracoabdominal block perichondral appearance
Postoperative analgesia will be provided with peripheral nerve block (TAPA)
Group II: IV MorphineProcedure or surgery
Also called intravenous morphine group
Postoperative analgesia will be provided with opioids
| Study group | Role | What they receive |
|---|---|---|
| Group I (n=45, TAPA) | The patients who received TAPA block for postoperative analgesia are named as a Group I ( n=45). The TAPA block is performed at the rib margin where the 9th and 10th ribs meet. A linear transducer is placed at the costochondral angle in the sagittal plane. It is carried out by injecting 20 ml of Bupivacaine %0.200 between the upper and lower surface of the chondrium. All patients receive IV PCA with morphine 0.5 mg/ml. Receives: Procedure: Group I: TAPA block | |
| Group II (n=45, IV opioid) | The patients who did not prefer the block and preferred intravenous patient-controlled analgesia (PCA) are named as Group II (n=45). IV PCA is prepared with morphine 0.5 mg/ml. Receives: Procedure: Group II: IV Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functions
Cognitive functions will be evaluated with Mini-mental test in each patient on postoperative day 3.
Measured: postoperative day 3
Secondary outcomes (2)
postoperative pain scores
Postoperative pain scores will be recorded. The evaluation will be made with Visual Analogue Scale (VAS) score in the 1st, 2nd, 6th, 12th and 24th hours postoperatively.
VAS score is determined via using a ruler, measuring the distance on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10.
Measured: 24 hours postoperatively
Postoperative morphine consumption within 24 hours postoperatively
Total morphine consumption in 24 hours postoperatively will be recorded via Patient Controlled Analgesi (PCA) device.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start10 Mar 2022
- Primary completion20 Aug 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guldeniz Argun, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Guldeniz Argun, 1, Study chair, SBU Abdurrahman YAOTRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215691
- Sponsor's protocol ID
- 2021-04/1098
- Acronym
- TAPA
- Status last verified
- Mar 2023
- First submitted
- 3 Dec 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krenk L, Rasmussen LS, Kehlet H. New insights into the pathophysiology of postoperative cognitive dysfunction. Acta Anaesthesiol Scand. 2010 Sep;54(8):951-6. doi: 10.1111/j.1399-6576.2010.02268.x. Epub 2010 Jul 12.
PubMed 20626359Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
PubMed 18156878Yirmiya R, Goshen I. Immune modulation of learning, memory, neural plasticity and neurogenesis. Brain Behav Immun. 2011 Feb;25(2):181-213. doi: 10.1016/j.bbi.2010.10.015. Epub 2010 Oct 21.
PubMed 20970492Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
PubMed 9525362Statzer N, Cummings KC 3rd. Transversus Abdominis Plane Blocks. Adv Anesth. 2018 Dec;36(1):163-180. doi: 10.1016/j.aan.2018.07.007. Epub 2018 Sep 27. No abstract available.
PubMed 30414636Tulgar S, Ahiskalioglu A, Selvi O, Thomas DT, Ozer Z. Similarities between external oblique fascial plane block and blockage of thoracoabdominal nerves through perichondral approach (TAPA). J Clin Anesth. 2019 Nov;57:91-92. doi: 10.1016/j.jclinane.2019.03.027. Epub 2019 Mar 29. No abstract available.
PubMed 30933854Ohgoshi Y, Ando A, Kawamata N, Kubo EN. Continuous modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) for major abdominal surgery. J Clin Anesth. 2020 Mar;60:45-46. doi: 10.1016/j.jclinane.2019.08.031. Epub 2019 Aug 20. No abstract available.
PubMed 31442859
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAPA Block Versus Conventional Analgesia Methods on Cognitive Functions and Postoperative Opioid Consumption in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05215691
- Acronym / sponsor ID
- TAPA / 2021-04/1098
- Conditions
- Pain, Postoperative, Cognition
- Keywords
- TAPA block, opioid consumption, cognitive functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 31 Jan 2022 (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.
It was planned to compare the opioid consumption and cognitive functions in the postoperative period of patients who received TAPA block for postoperative analgesia and patients who did not prefer the block and who preferred intravenous patient-controlled analgesia (PCA) with opioids. Both the surgery applied and the drugs used in anesthesia can cause changes in cognitive functions by affecting the inflammatory process. It is thought that if the patients' pain can be relieved sufficiently in the postoperative period with TAPA block, the consumption of opioids used will be less and their cognitive functions will be less affected.
Detailed description
Postoperative pain management after major surgical operations is a very important issue. Features such as waking up without pain, early recovery from anesthesia, not suppressing respiration by the drugs used for postoperative pain treatment, not delaying recovery from anesthesia, not having unwanted side effects, and not delaying discharge from the intensive care unit are the desired features of postoperative pain management. A wide variety of drug therapy modalities are available for this purpose. However, peripheral nerve blocks are widely used to minimize undesirable effects of drug therapy. TAP block (trans abdominal plane block) has been used for this purpose since ancient times. TAPA block (thoracoabdominal block with perichondral approach) is a newly developed plane block and was developed to obtain higher level block with a single injection. In this study, we planned to compare the recovery times from anesthesia, postoperative pain scores, opioid consumption, and cognitive functions of patients who underwent TAPA block for postoperative pain treatment and patients who were not preferred to TAPA block and were planned for pain treatment with conventional methods, whether these treatments affected or not.
Neuropsychological dysfunction is a frequently encountered condition after surgery. Postoperative cognitive dysfunction can affect various cognitive functions such as attention, memory, and information processing speed. The most notable symptoms are memory deficits and decreased ability to cope with intellectual difficulties. It has been stated that postoperative cognitive dysfunction depends on advanced age, duration of anesthesia, development of complications, pre-existing cognitive disorders, and education level.
In a study, it was reported that the incidence of postoperative cognitive dysfunction in patients aged around 60 years who underwent major noncardiac surgery was 25.8% after 1 week and 9.9% after 3 months.
In the literature, it has been mentioned that inflammatory processes that occur as a result of surgical trauma and subsequent complications play a role in cognitive dysfunction. Normal cognitive functions can be maintained in low-level inflammatory processes, while very high-level proinflammatory factors can significantly affect cognitive functions.
Traditional lateral TAP block is performed on the midaxillary line between the iliac crest and subcostal. With this approach, with cadaveric dye injection, T11 was shown to be maintained and T12 was maintained 100% time, L1 93% time and T10 50% time. The lateral TAP block reached a dermatome high enough to benefit the patient after open cholecystectomy.
The TAPA block is performed at the rib margin where the 9th and 10th ribs meet. A linear transducer is placed at the costochondral angle in the sagittal plane. It is carried out by injecting 20 ml of drug between the upper and lower surface of the chondrium. The authors state that TAPA block provides analgesia to T5-T12. They hypothesize that the TAPA block numbs both the lateral cutaneous branch and the anterior region.
Although the standardized mini-mental test is not a definitive diagnostic test, it is used by clinicians as an auxiliary test to measure the degree of cognitive deterioration of patients.
We planned this study to compare the recovery times from anesthesia, postoperative pain scores, opioid consumption, and cognitive functions of patients who underwent TAPA block for postoperative pain management and patients who were not preferred TAPA block and were planned for pain treatment with conventional methods, whether these treatments were affected or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (n=45, TAPA) | – | Procedure: Group I: TAPA blockThe patients who received TAPA block for postoperative analgesia are named as a Group I ( n=45). The TAPA block is performed at the rib margin where the 9th and 10th ribs meet. A linear transducer is placed at the costochondral angle in the sagittal plane. It is carried out by injecting 20 ml of Bupivacaine %0.200 between the upper and lower surface of the chondrium. All patients receive IV PCA with morphine 0.5 mg/ml. |
| Group II (n=45, IV opioid) | – | Procedure: Group II: IV MorphineThe patients who did not prefer the block and preferred intravenous patient-controlled analgesia (PCA) are named as Group II (n=45). IV PCA is prepared with morphine 0.5 mg/ml. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who will undergo major abdominoplasty, ASA II and ASA III, over the age of 18, under the age of 85 in the Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital.
Key inclusion criteria (4 listed)
- patients who will undergo major abdominoplasty,
- over the age of 18,
- under the age of 85,
- patients who has ASA (American Society of Anesthesiologists) II and ASA III criteria
Key exclusion criteria (11 listed)
- younger than 18 years old, over 85 years old,
- Having a history of cerebrovascular disease
- Having surgery other than oncological surgery
- having coagulation disorder
- being illiterate
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 I: TAPA blockAlso: thoracoabdominal block perichondral appearancePostoperative analgesia will be provided with peripheral nerve block (TAPA) | Procedure or surgery | Group I (n=45, TAPA) |
| Group II: IV MorphineAlso: intravenous morphine groupPostoperative analgesia will be provided with opioids | Procedure or surgery | Group II (n=45, IV opioid) |
Primary outcome
Cognitive functions
Time frame: postoperative day 3
Cognitive functions will be evaluated with Mini-mental test in each patient on postoperative day 3.
2 secondary outcomes
postoperative pain scores
Time frame: 24 hours postoperatively
Postoperative morphine consumption within 24 hours postoperatively
Time frame: 24 hours postoperatively
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 2 Mar 2023.
- Background: PubMed 20626359Krenk L, Rasmussen LS, Kehlet H. New insights into the pathophysiology of postoperative cognitive dysfunction. Acta Anaesthesiol Scand. 2010 Sep;54(8):951-6. doi: 10.1111/j.1399-6576.2010.02268.x. Epub 2010 Jul 12.
- Background: PubMed 18156878Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
- Background: PubMed 20970492Yirmiya R, Goshen I. Immune modulation of learning, memory, neural plasticity and neurogenesis. Brain Behav Immun. 2011 Feb;25(2):181-213. doi: 10.1016/j.bbi.2010.10.015. Epub 2010 Oct 21.
- Results publication: PubMed 9525362Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
- Results publication: PubMed 30414636Statzer N, Cummings KC 3rd. Transversus Abdominis Plane Blocks. Adv Anesth. 2018 Dec;36(1):163-180. doi: 10.1016/j.aan.2018.07.007. Epub 2018 Sep 27. No abstract available.
- Results publication: PubMed 30933854Tulgar S, Ahiskalioglu A, Selvi O, Thomas DT, Ozer Z. Similarities between external oblique fascial plane block and blockage of thoracoabdominal nerves through perichondral approach (TAPA). J Clin Anesth. 2019 Nov;57:91-92. doi: 10.1016/j.jclinane.2019.03.027. Epub 2019 Mar 29. No abstract available.
- Results publication: PubMed 31442859Ohgoshi Y, Ando A, Kawamata N, Kubo EN. Continuous modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) for major abdominal surgery. J Clin Anesth. 2020 Mar;60:45-46. doi: 10.1016/j.jclinane.2019.08.031. Epub 2019 Aug 20. No abstract available.
- 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.
Guldeniz Argun, 1 study chair
SBU Abdurrahman YAOTRH
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 Cognition, run by Dr Abdurrahman Yurtaslan Ankara Oncology 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 4 inclusion and 11 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 2 Mar 2023. 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?
Cognitive functions (time frame: postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215691, which also lists 7 linked publications.
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 2 Mar 2023.