NCT04364477

Brief Summary

INTRODUCTION: The aim of this study was to investigate the effects of tranversus abdominis plane (TAP) block placed postoperatively using ultrasound guidance for patients with caesarean section, myomectomy and hysterectomy under general anesthesia by eliminating additional pain caused by surgical incision. MATERIALS AND METHODS: The study has been planned to investigate the postoperative analgesia of 50 patients with TAP blocks applied and non-applied between the ages of 18-65, who will pass abdominal surgery. Study has been conducted in a prospective, randomized and controlled manner. Patients have been classified as those who have undergone TAP block (group: I) and those without block (group: II).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

Study Start

First participant enrolled

January 4, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2016

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 23, 2020

Last Update Submit

April 25, 2020

Conditions

Keywords

TAP blockpostoperative painBupivacaineultra sound guided regional anesthesia

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale of patients

    Pain scale

    0-30 minutes

  • Sistolic Blood Pressure of patients

    Sistolic Blood Pressure

    0-30 minutes

  • Need For Analgesic drugs for post-op patients

    Analgesic need

    0-60 minutes

  • patients with nausea

    post op nausea

    0-60 minutes

Study Arms (2)

Tap block Group

ACTIVE COMPARATOR

Tap Block group :(Group 1) After General anestehesia At the end of the operation, TAP blocks were placed to the 1st group patients.

Procedure: transversus abdominis plane (TAP) block

Control Group

PLACEBO COMPARATOR

No block applied. only General anesthesia was applied.

Procedure: transversus abdominis plane (TAP) block

Interventions

The transversus abdominis plane (TAP) block is a regional anesthesia technique described in recent years that provides analgesia for the anterior portion of the abdominal wall after abdominal surgery.

Also known as: General Anesthesia
Control GroupTap block Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative ComplicationsPain, Postoperative

Interventions

Dental OcclusionAnesthesia, General

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 28, 2020

Study Start

January 4, 2015

Primary Completion

January 4, 2016

Study Completion

February 1, 2016

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share