NCT06412796

Brief Summary

Open Gastrectomy surgery is a big surgery with upper umbilical median incision where the postoperative pain is occur frequently. pain managements of this surgery with intravenous opioid analgesics are currently standard approach. but its side effects as sedation, decreased bowel movement and respiratory depression are limiting its use. so local anesthesia done with regional block methods provides good analgesia after surgery that decrease use of opioid analgesics. in this study we intend to compare subcostal TAP block with external oblique intercostal block

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

May 9, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 26, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 9, 2024

Last Update Submit

May 9, 2024

Conditions

Keywords

SCTAPExternal Oblique Intercostal blockpostoperative analgesia

Outcome Measures

Primary Outcomes (2)

  • Need of morphine analgesia

    postoperatively monitoring of patients that need analgesics by morphine consumption using a patient contral analgesics device that record amount of used and wanted analgesics by patients themselves

    24 hours

  • patients pain scales

    asking patients for pain at postoperative period by visual analog scale and score accordingly

    24 hours

Study Arms (2)

Subcostal Transversus Abdominis Plane (SCTAP) block.

SCTAP Block is performing by USG probe positioned on the anterior abdominal wall immediately inferior to the costal margin and then needle advanced to 2 to 3 cm lateral to the aponeurosis of the external oblique muscles, internal oblique muscles, and transversus abdominis in the TAP. Saline 0.5mL was injected to determine the position of the transverse fascia and 15-20 ml local anesthetics injected both in right and left sides of abdomen.

External Oblique Intercostal (EOI) block

EOI block is performed by placing the US probe in paramedian sagittal orientation at the T6-7 level and visualizing the external oblique and intercostal muscles. Local anesthetics inject the under the external oblique muscle.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all adult patients with gastric cancer who are undergoing gastrectomy and agreed for a study are accepted

You may qualify if:

  • patients who have diagnosed Gastric Cancer and undergoing Gastric resection
  • patients accepted to participate for study

You may not qualify if:

  • parients that not agreed for the study
  • patients who undergoing for second operation at the same surgery incision
  • patient that have chronic pains and multiple drugs using
  • patients that have psychiatric disorders
  • bariatric surgery
  • patients with allergics for local anaesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Erciyes

Kayseri, Talas, 38100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Ayşe Ülgey, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 14, 2024

Study Start

June 26, 2024

Primary Completion

February 25, 2025

Study Completion

March 25, 2025

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations