Effects of Fascial Plan Blocks on Pulmonary Functions

Sponsor
Zonguldak Bulent Ecevit University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06144307
Collaborator
(none)
1
1
15
0.1

Study Details

Study Description

Brief Summary

In addition to the traumatic effect of the operation, the effort to immobilize the auxiliary respiratory muscles due to pain causes a decrease in postoperative respiratory function (especially in thoracic and upper abdominal surgeries). In addition, superficial and tachypneic breathing caused by the inability of the patient to take deep breaths with pain leads to closure of small airways and increase in intrapulmonary shunts, resulting in hypoxia. Postoperative pain management is important not only to prevent pain but also to reduce pulmonary complications that may occur due to changes in lung function and to reduce mortality and morbidity by controlling the stress response. Pain after nausea and vomiting is the most common reason for hospitalization after laparoscopic surgery.

Although pain in laparoscopic cholecystectomy (LC) has many components including incisional, visceral and reflected, the primary source of pain is incisional pain. A multimodal analgesic approach (NSAII, paracetamol, opioids, local infiltration, facial plane blocks and paravertebral and periparavertebral blocks) is recommended. Regional anesthesia combined with general anesthesia reduces the stress response associated with surgery and reduces the need for opioid use. Subcostal TAP Block; injection of local anesthetic between the internal oblique and transversus abdominis muscles in the upper quadrant of the anterior abdominal wall blocks the anterior cutaneous branches of the thoracoabdominal nerves. External Oblique Fascial Plane Block (EOIB); blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves. It is performed between the 6th-7th costae. There is a cutaneous sensory block between T6-T9 in the midabdomen and T6-T10 in the anterior axillary line.

The conventional method is the administration of intravenous opioids as a method of postoperative analgesia when the routine block cannot be performed due to a contraindication.

Condition or Disease Intervention/Treatment Phase
  • Procedure: plane block

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effects of External Oblique Fascial Plan Block and Subcostal Transversus Abdominis Plan Block on Postoperative Pulmonary Functions
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
External Oblique Fascial Plan Block

Procedure: plane block
injection of local anesthetic to the myofascial plane

Subcostal Transversus Abdominis Plan Block

Procedure: plane block
injection of local anesthetic to the myofascial plane

Control

Outcome Measures

Primary Outcome Measures

  1. the effect of plane blocks on postoperative pulmonary function [during the postoperative 24 hours]

    The effect of pain relief after plane blocks on postoperative pulmonary function

Secondary Outcome Measures

  1. opioid consumption [during the postoperative 24 hours]

    need for opioids as a result of pain

  2. Incidence of nausea and vomiting [during the postoperative 24 hours]

    Need for nausea and vomiting

  3. quality of recovery-15 [during the postoperative 24 hours]

    Quality of recovery of patients by survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 18-65 years old

  • ASA I-II-III risk group

  • Patients whose consent was obtained with an informed consent form

  • She will undergo a cholecystectomy operation

  • Patients to be cooperative for SFT test

Exclusion Criteria:
  • <18 years and >65 years

  • ASA ≥ IV

  • Pulmonary function test below 50% of the expected value

  • Known diaphragm paralysis

  • Body mass index >30

  • Myocardial infarction within 1 month

  • Dementia or confusion

  • Lack of cooperation

  • People with respiratory diseases

  • Congestive heart failure

  • Unstable hypertension

  • Thoracoabdominal surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zonguldak Bülent Ecevit University Faculty of Medicine Kozlu Zonguldak Turkey 67600

Sponsors and Collaborators

  • Zonguldak Bulent Ecevit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bengü Gülhan Köksal, Medical Doctor, Zonguldak Bulent Ecevit University
ClinicalTrials.gov Identifier:
NCT06144307
Other Study ID Numbers:
  • 2023/04-3
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
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 Bengü Gülhan Köksal, Medical Doctor, Zonguldak Bulent Ecevit University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2023