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

Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05215691
Collaborator
(none)
90
1
9.5
9.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Group I: TAPA block
  • Procedure: Group II: IV Morphine

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

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
TAPA Block Versus Conventional Analgesia Methods on Cognitive Functions and Postoperative Opioid Consumption in Major Abdominal Surgery
Actual Study Start Date :
May 17, 2021
Actual Primary Completion Date :
Feb 20, 2022
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm 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.

Procedure: Group I: TAPA block
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.

    Procedure: Group II: IV Morphine
    Postoperative analgesia will be provided with opioids
    Other Names:
  • intravenous morphine group
  • Outcome Measures

    Primary Outcome Measures

    1. Cognitive functions [postoperative day 3]

      Cognitive functions will be evaluated with Mini-mental test in each patient on postoperative day 3.

    Secondary Outcome Measures

    1. postoperative pain scores [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.

    2. Postoperative morphine consumption within 24 hours postoperatively [24 hours postoperatively]

      Total morphine consumption in 24 hours postoperatively will be recorded via Patient Controlled Analgesi (PCA) device.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SBU Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Ankara Turkey 06200

    Sponsors and Collaborators

    • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Guldeniz Argun, associate professor, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05215691
    Other Study ID Numbers:
    • 2021-04/1098
    First Posted:
    Jan 31, 2022
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guldeniz Argun, associate professor, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022