NCT06939725

Brief Summary

Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. The scientifically accepted developed method is multimodal analgesia protocols. These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block). The aim of this study is to continue the analgesia protocols applied in cesarean section surgeries on the first 24-hour pain scores, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 15, 2025

Last Update Submit

April 27, 2025

Conditions

Keywords

ObsQoR-10Transversalis fascia plane blockCaesarean SectionTransverse abdominis plane blocknumeric rating scale

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Pain levels of patients will be evaluated with the Numerical Pain Scale (NRS) in the first 24 hours postoperatively. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    postoperative 24 hours

Secondary Outcomes (1)

  • ObsQoR-10

    Postoperative 24 hours

Study Arms (2)

Group 1

Transversus abdominis plane block was performed immediately after cesarean section.

Other: Transversus abdominis plane (TAP) block

Group 2

Transversalis fascial plane block was performed immediately after cesarean section

Other: Transversalis Fascia Plane Block

Interventions

We apply different nerve blocks to patients for pain relief after cesarean surgery. Transversus abdominis plane block was applied to this group

Group 1

We apply different nerve blocks to patients for pain relief after cesarean surgery. Transversalis Fascia Plane Block was applied to this group

Group 2

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants who underwent elective cesarean section and received regional anesthesia for postoperative analgesia

You may qualify if:

  • \>18 years
  • Term pregnancies (37-42 weeks) and those planned to undergo elective cesarean delivery under spinal anesthesia

You may not qualify if:

  • \<18 years
  • Emergency surgery
  • BMI \> 35 kg/m2 or anatomic conditions that would preclude spinal anesthesia
  • Increased susceptibility to bleeding or coagulation disorders (platelet count below 80,000× 10\^3/mm\^3 or INR \> 1.5)
  • Known allergy to any drug, such as local anesthetics, opioids, or NSAIDs
  • Other relevant maternal or neonatal clinical conditions requiring treatment and at the discretion of the investigators, such as gestational hypertension, impaired renal or hepatic function, postpartum hemorrhage
  • Chronic pain conditions and concomitant use of analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University, Training and Research Hospital

Samsun, İ̇lkadim, 55000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • SEVDA AKDENIZ, Assoc Prof

    Samsun University

    PRINCIPAL INVESTIGATOR
  • HATİCE SELÇUK KUŞDERCİ, Asst. Prof.

    Samsun University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 23, 2025

Study Start

January 1, 2025

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations