Clinical trial NCT06978491: Evaluation of the Effect of Postoperative Analgesia Techniques With ObsQoR-10
Official title: Evaluation of the Effect of Postoperative Analgesia Techniques on Obstetric Recovery Quality With ObsQoR-10
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Postoperative Complications
Keywords: cesarean section
postoperative analgesia
Quality of recovery
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group C: spinal anesthesia.

Group T: spinal anesthesia and at the end of the surgery, 0.25% bupivacaine and 20 ml of local anesthetic will be applied bilaterally between the transversus abdominis and internal oblique muscle.

Group W (wound infiltration) : spinal anesthesia and at the end of the surgery, 0.25% bupivacaine and 20 ml of local anesthetic will be applied to the wound site.
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effects of postoperative analgesia techniques-transversus abdominis plane (TAP) block and wound infiltration-on recovery in patients undergoing elective cesarean section, using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. The secondary objective is to assess pain scores, analgesic consumption, and adverse effects such as nausea, vomiting, and pruritus within the first 24 hours postoperatively.

Detailed description: The patients will be divided into 3 groups as Group T (transversus abdominis plane block), Group W (wound infiltration) and Group K (control). All of them will be given spinal anesthesia in sitting position.Group C will receive spinal anesthesia. In Group T (Transversus abdominis plane block) cases, in addition to spinal anesthesia at the end of the surgery, 20 ml of 0.25% bupivacaine will be applied bilaterally between the transversus abdominis muscle and the internal oblique muscle. Group WI (wound infiltration) will be administered 20 ml 0.25% bupivacaine to the wound area in addition to spinal anesthesia at the end of the surgery.Numerical pain scores (NRS Resting and Movement), heart rate, mean arterial pressure, peripheral oxygen saturation, analgesic consumption, nausea and vomiting score, pruritus, Ramsey sedation scale and other postoperative complications will be recorded at the 2nd hour, 6th hour, 12th hour and 24th hour postoperatively .Obstetric Quality of Recovery -ObsQoR-10 questionnaire will be applied to the patients at the end of 24 hours.

Eligibility criteria: Inclusion Criteria:

* Term obstetric patients aged 18-50 years who underwent elective cesarean section under spinal anesthesia and applied regional anesthesia techniques such as TAP and wound infiltration.

Exclusion Criteria:

* Refuse to participate in the study
* Patients who have undergone general anesthesia
* Patients requiring emergency cesarean section.
* Mental status disorders
* Known bleeding and/or coagulation disorders
* Infection at injection site

Primary outcomes:
measure: Obstetric Quality of Recovery-10
timeFrame: At postoperative 24th hours
Secondary outcomes:
measure: Postoperative pain score, analgesic consumption
timeFrame: At postoperative 24 hours (0, 2, 6,12,24)
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi Universıty Faculty of Medicine
state: Eski̇şehi̇r
Study officials:
affiliation: Eskisehir Osmangazi University Faculty Of Medıcıne
name: Meryem Onay
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28.
citation: Nasir F, Sohail I, Sadiq H, Habib M. Local Wound Infiltration with Ropivacaine for Postoperative Pain Control in Caesarean Section. Cureus. 2019 Sep 5;11(9):e5572. doi: 10.7759/cureus.5572.
citation: Riemma G, Schiattarella A, Cianci S, La Verde M, Morlando M, Sisti G, Esposito I, Della Corte L, Sansone P, De Franciscis P. Transversus abdominis plane block versus wound infiltration for post-cesarean section analgesia: A systematic review and meta-analysis of randomized controlled trials. Int J Gynaecol Obstet. 2021 Jun;153(3):383-392. doi: 10.1002/ijgo.13563. Epub 2021 Feb 11.
citation: Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20.