Transversus Abdominis Plane Block Versus Rectus Sheath Bl... | NCT03811067

Studies
Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery

NCT03811067

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Jul 23, 2019Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Transversus abdominis plane block
Rectus sheath block

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

Jul 2019

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

Apr 25, 2019Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Jul 15, 2019Actual

First Submitted Date

Jan 18, 2019

First Submission Date that Met QC Criteria

Jan 18, 2019

First Posted Date

Jan 22, 2019Actual

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

Jul 22, 2019

Last Update Posted Date

Jul 23, 2019Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Overall, for cesarean delivery, interaction between the mother and her newborn baby can be provided earlier. Many regional anesthesia techniques can be prefferred after cesarean delivery. Aim of the study is to compare the postoperative analgesia effects of transversus abdominis plane block and rectus sheath block after elective cesarean delivery.

Detailed Description

Not provided

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	No Intervention
TAP group	Active Comparator	Transversus abdominis plane block administered group	Procedure: Transversus abdominis plane block
RS group	Active Comparator	Rectus sheath block administered group	Procedure: Rectus sheath block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transversus abdominis plane block	Procedure	Transversus abdominis plane block will be performed bilaterally after the surgery.	TAP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morphine consumption	Morphine consumption (mg) of patients with patient controlled device	Postoperative 24th hour.
NRS score	Numerating rating scale of patients	Postoperative 24th hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II patients Patients undergo elective cesarean delivery Gestation period between 37-40 weeks

Exclusion Criteria:

obesity (body mass index >35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hadi Ufuk MD Yörükoğlu	Kocaeli University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University		Kocaeli		41350	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
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided