Comparison of OSTAP and EOIP Blocks in Laparoscopic Chole... | NCT06172465

Studies
Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies

NCT06172465

Sponsor

Samsun University

Status

Completed

Last Update Posted

Nov 27, 2024Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Analgesia
Pain, Post Operative

Interventions

EOIP
OSTAP

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2024Actual

Primary Completion Date

Nov 24, 2024Actual

Completion Date

Nov 25, 2024Actual

First Submitted Date

Dec 7, 2023

First Submission Date that Met QC Criteria

Dec 7, 2023

First Posted Date

Dec 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2024

Last Update Posted Date

Nov 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Laparoscopic cholecystectomy (LC) surgery causes postoperative severe pain. As part of multimodal analgesia aimed at reducing postoperative opioid consumption and providing effective analgesia, ultrasound (US)-guided transversus abdominis plane block (TAP) and external oblique intercostal plane block (EOIPB) will be applied as regional anesthesia methods. There is no study in the literature comparing OSTAP and EOIP blocks, and our goal is to evaluate the analgesic effectiveness between OSTAP and EOIP blocks in LC surgeries.

Detailed Description

Patients will be divided into two groups, and general anesthesia will be administered to all. Before extubation, one group will receive an external oblique intercostal nerve block, while the other group will receive an oblique subcostal transversus abdominis plane block. The randomization of the study will be carried out by a computer-generated randomization code (computer-generated) by a physician who will not be involved in patient follow-up. The interfascial plane block (either external oblique intercostal block or oblique subcostal block) will be provided to an anesthesiologist in a sealed envelope by an independent assistant staff member outside the study. The patient will not be aware of which block is applied. The anesthesiologist performing the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be conducted by another anesthesiologist unaware of the study.

For standardization, the block procedure will be performed by an experienced anesthesiologist who has completed at least 20 previous successful and uncomplicated procedures.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group external oblique intercostal plane block	Active Comparator	While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules at end of the surgery.	Other: EOIP
group oblique subcostal transversus abdominis plane block	Active Comparator	Ultrasound-guided bilateral OSTAP block performed at end of the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed	Other: OSTAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EOIP	Other	Ultrasound guided External oblique intercostal block will be performed bilaterally.	group external oblique intercostal plane block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative opioid consumption	tramadol consumption in the first 24 hours after surgery	up to 24 hours

Secondary Outcomes

Measure	Description	Time Frame
NRS scores	NRS scores in the first 24 hours after surgery	At 1,3, 6, 12, 18, 24 hours
Quality of recovery	QR15 scores	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI < 35 kg/m² Patients with ASA scores I and II

Exclusion Criteria:

Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA > 3 BMI > 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
gamze MD ertaş, specialist	Samsun University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsun University		Samsun	Ilkadım	55100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

Masking Description

The anesthetist who will perform the blocks will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.

Who Masked

ParticipantCare ProviderOutcomes Assessor