Examination of the Postoperative Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section Surgeries Performed Under Spinal Anesthesia
| Registry | NCT06386978 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, treatment |
| Enrollment | 90 (Actual) |
| Sponsor | TC Erciyes University (Other) |
| Conditions | Obstetric |
| Interventions | Transverse Facia Plane Block (TAP Block), Transversalis Facia Plane Block (TFP Block), Control (Procedure) |
| Dates | start 2025-05-30, primary completion 2025-09-30, completion 2025-12-15, first posted 2024-04-26, last updated 2025-12-23 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Obstetric All trials of Transverse Facia Plane Block (TAP Block) All trials of Transversalis Facia Plane Block (TFP Block)
This study was designed as a prospective, randomized observational clinical trial.
A total of 90 adult women were included in the study performed elective cesarean section.
After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block;
This study was designed as a prospective, randomized observational clinical trial. Erciyes University Clinical Research Ethics Board 2024/209.
All participants in the study were adults and their information was confirmed in writing. Preoperative anesthesia assessment was made by an anesthetic injection, cesarean section surgeries for 90 women were planned to be performed on elective conditions among those registered between May 2024 and May 2025. ASA score, anesthesia method, age, weight, height, TAP block group (Group I) or TFP block group (Group II), Control group (Group III) :
Duration of spinal anesthesia, time of first analgesic request, total analgesic consumption for 24-48 hours, VAS score, additional analgesics, patient satisfaction, possible postoperative bleeding, vomiting, heat retention and other interruptions were recorded in the patients.
Those who were allergic to local anesthetics, steroid treatment areas, ASA III, ASA IV and ASA V, patients under the age of 18, preeclampsia, eclampsia, placenta percreta and accreta complications and emergency hospitals were excluded from the study. After excluding patients, the care of 90 was included and 3 of these amounts were reserved.
TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3): Spinal Anesthesia + No block; At the end of the surgery, TAP (Transverse Abdominis Plane Block) Block or TFP (Transversalis Fascia Plane Block) block was performed under aseptic conditions under ultrasonography guidance.
TAP (Transverse Abdominis Plane Block) Block for Group 1 patients and TFP (Transversalis Fascia Plane Block) block for Group 2 patients on both sides after negative aspiration, with 20 ml 0.25% bupivacaine (Marcaine®, Astra-Zeneca, Turkey) under ultrasonography guidance. It was done under aseptic conditions.
Patients who did not accept both blocks were included in Group 3 (Control group).
All patients were trained on visual analog score (VAS) by the anesthesia assistant during the preoperative evaluation. VAS used for pain assessment, a 10 cm long horizontal line was used.
From 0= (no pain) to 10= (most severe pain).
PCA morphine administration to all patients: The hourly limit was set as 4 mg, and the repeat limit was set as 10 minutes. If the 1 mg IV morphine bolus dose was not sufficient, it was planned to repeat it after 10 minutes, and if it was still not sufficient, paracetamol and diclofenac were planned to be administered.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TAP Group | Active comparator | Procedure: Transverse Facia Plane Block (TAP Block) | TAP (Transverse Abdominis Plane Block) Block was performed in Group 1 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance. |
| TFP Group | Active comparator | Procedure: Transversalis Facia Plane Block (TFP Block) | TFP (Transversalis facia plane block ) Block was performed in Group 2 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance. |
| Control Group | Active comparator | Procedure: Control | Patients in the Third group will be considered the control group and no block will be performed |
Sex: Female, ages: 18 Years to 49 Years, accepts healthy volunteers
Inclusion Criteria: * ASA I and ASA II, * Pregnant patients accepting spinal anesthesia and procedure Exclusion Criteria: * Those who are allergic to local anesthetics, * Those receiving steroid treatment, * ASA III, ASA IV and ASA V, * Patients under the age of 18, * Patients with preeclampsia, * Eclampsia, * Placenta percreta and accreta and its complications, * Emergency patients.
| Facility | City | Country | Status |
|---|---|---|---|
| Erciyes University | Kayseri | Turkey (Türkiye) |