NCT06144307

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

November 16, 2023

Last Update Submit

May 21, 2025

Conditions

Keywords

postoperative painplane blockpulmonary function

Outcome Measures

Primary Outcomes (1)

  • the effect of plane blocks on postoperative pulmonary function

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

    during the postoperative 24 hours

Secondary Outcomes (3)

  • opioid consumption

    during the postoperative 24 hours

  • Incidence of nausea and vomiting

    during the postoperative 24 hours

  • quality of recovery-15

    during the postoperative 24 hours

Study Arms (3)

External Oblique Fascial Plan Block

Procedure: plane block

Subcostal Transversus Abdominis Plan Block

Procedure: plane block

Control

Interventions

plane blockPROCEDURE

injection of local anesthetic to the myofascial plane

External Oblique Fascial Plan BlockSubcostal Transversus Abdominis Plan Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who will undergo cholecystectomy between the ages of 18-65

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Faculty of Medicine

Kozlu, Zonguldak Province, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

December 1, 2023

Primary Completion

October 30, 2024

Study Completion

December 31, 2024

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations