NCT05215691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

December 3, 2021

Last Update Submit

March 1, 2023

Conditions

Pain, PostoperativeCognition

Keywords

TAPA block, opioid consumption, cognitive functions

Outcome Measures

Primary Outcomes (1)

  • Cognitive functions

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

    postoperative day 3

Secondary Outcomes (2)

  • postoperative pain scores

    24 hours postoperatively

  • Postoperative morphine consumption within 24 hours postoperatively

    24 hours postoperatively

Study Arms (2)

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

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

Interventions

Group I: TAPA blockPROCEDURE

Postoperative analgesia will be provided with peripheral nerve block (TAPA)

Also known as: thoracoabdominal block perichondral appearance
Group I (n=45, TAPA)
Group II: IV MorphinePROCEDURE

Postoperative analgesia will be provided with opioids

Also known as: intravenous morphine group
Group II (n=45, IV opioid)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Related 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.

    PMID: 20626359BACKGROUND

  • 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.

    PMID: 18156878BACKGROUND

  • 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.

    PMID: 20970492BACKGROUND

  • 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 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.

    PMID: 9525362RESULT

  • 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.

    PMID: 30414636RESULT

  • 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.2019.03.027. Epub 2019 Mar 29. No abstract available.

    PMID: 30933854RESULT

  • 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 abstract available.

    PMID: 31442859RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Guldeniz Argun, 1

    SBU Abdurrahman YAOTRH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 3, 2021

First Posted

January 31, 2022

Study Start

March 10, 2022

Primary Completion

August 20, 2022

Study Completion

September 10, 2022

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)