Clinical trial NCT06939725: Transverse Abdominis Plane (TAP) Block Versus Transversalis Fascia Plane Block (TFPB) After Cesarean Delivery
Official title: Outcomes of Postoperative Analgesia Protocols and Their Impact on Recovery Quality in Patients Undergoing Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain Management
Caesarean Section
Keywords: ObsQoR-10
Transversalis fascia plane block
Caesarean Section
Transverse abdominis plane block
numeric rating scale
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who underwent elective cesarean section and received regional anesthesia for postoperative analgesia

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.

Detailed description: 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). In this study, transversus abdominis plane block or transversalis fascial plane block was applied to the participants immediately after surgery. The aim is to continue the analgesia protocols applied to the cesarean section surgeries on the pain scores in the first 24 hours, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.

Eligibility criteria: Inclusion Criteria:

1. \>18 years
2. Term pregnancies (37-42 weeks) and those planned to undergo elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

1. \<18 years
2. Emergency surgery
3. BMI \> 35 kg/m2 or anatomic conditions that would preclude spinal anesthesia
4. Increased susceptibility to bleeding or coagulation disorders (platelet count below 80,000× 10\^3/mm\^3 or INR \> 1.5)
5. Known allergy to any drug, such as local anesthetics, opioids, or NSAIDs
6. 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
7. Chronic pain conditions and concomitant use of analgesics

Primary outcomes:
measure: Postoperative pain
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: ObsQoR-10
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University, Training and Research Hospital
state: İ̇lkadim
Study officials:
affiliation: Samsun University
name: SEVDA AKDENIZ, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsun University
name: HATİCE SELÇUK KUŞDERCİ, Asst. Prof.
role: STUDY_DIRECTOR
References: