Outcomes of Thoracoabdominal Nerve Block Through Perichondrial Approach* on Postoperative Cognitive Functions (TAPA)

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06200
        • SBU Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Postoperative analgesia will be provided with peripheral nerve block (TAPA)
Other Names:
  • thoracoabdominal block perichondral appearance
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.
Postoperative analgesia will be provided with opioids
Other Names:
  • intravenous morphine group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive functions
Time Frame: postoperative day 3
Cognitive functions will be evaluated with Mini-mental test in each patient on postoperative day 3.
postoperative day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain scores
Time Frame: 24 hours postoperatively

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
Postoperative morphine consumption within 24 hours postoperatively
Time Frame: 24 hours postoperatively
Total morphine consumption in 24 hours postoperatively will be recorded via Patient Controlled Analgesi (PCA) device.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Guldeniz Argun, 1, SBU Abdurrahman YAOTRH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

August 20, 2022

Study Completion (Actual)

September 10, 2022

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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