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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05215691
Other study ID # 2021-04/1098
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2022
Est. completion date September 10, 2022

Study information

Verified date March 2023
Source Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date September 10, 2022
Est. primary completion date August 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. patients who will undergo major abdominoplasty, 2. over the age of 18, 3. under the age of 85, 4. patients who has ASA (American Society of Anesthesiologists) II and ASA III criteria Exclusion Criteria: 1. younger than 18 years old, over 85 years old, 2. Having a history of cerebrovascular disease 3. Having surgery other than oncological surgery 4. having coagulation disorder 5. being illiterate 6. having visual and auditory problems 7. Inability to cooperate with cognitive function test 8. having an emergency surgery 9. Those who are not able to read and sign the consent form 10. Patients deemed unsuitable by the researcher 11. Patients who do not want to participate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Group I: TAPA block
Postoperative analgesia will be provided with peripheral nerve block (TAPA)
Group II: IV Morphine
Postoperative analgesia will be provided with opioids

Locations

Country Name City State
Turkey SBU Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

Moller 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 posto — View Citation

Monk 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. — View Citation

Ohgoshi 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 abst — View Citation

Statzer 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. — View Citation

Tulgar 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 — View Citation

Yirmiya 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive functions Cognitive functions will be evaluated with Mini-mental test in each patient on postoperative day 3. postoperative day 3
Secondary 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.
24 hours postoperatively
Secondary Postoperative morphine consumption within 24 hours postoperatively Total morphine consumption in 24 hours postoperatively will be recorded via Patient Controlled Analgesi (PCA) device. 24 hours postoperatively
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