NCT03811067

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable postoperative-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

January 18, 2019

Last Update Submit

July 22, 2019

Conditions

Postoperative Pain

Keywords

Postoperative painTransversus abdominis plane blockRectus sheath blockCesarean delivery

Outcome Measures

Primary Outcomes (2)

  • Morphine consumption

    Morphine consumption (mg) of patients with patient controlled device

    Postoperative 24th hour.

  • NRS score

    Numerating rating scale of patients

    Postoperative 24th hour

Study Arms (3)

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

Transversus abdominis plane blockPROCEDURE

Transversus abdominis plane block will be performed bilaterally after the surgery.

TAP group
Rectus sheath blockPROCEDURE

Rectus sheath block will be performed bilaterally after the surgery.

RS group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41350, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hadi Ufuk MD Yörükoğlu

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 22, 2019

Study Start

April 25, 2019

Primary Completion

July 1, 2019

Study Completion

July 15, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)