Evaluation of the Effect of Postoperative Analgesia Techniques With ObsQoR-10

NCT06978491 | Recruiting

• 1 other identifier: ESOGU 6
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Postoperative Complications

Keywords

cesarean section; postoperative analgesia; Quality of recovery

Outcome Measures

Primary Outcomes (1)

• Obstetric Quality of Recovery-10

  The ObsQoR-10 questionnaire consists of 10 questions that assess the patient-reported quality of recovery in obstetric patients' postoperative period using an 11-point scale (0 = strongly negative; 10 = strongly positive) that points to a minimum score of 0 (worst possible recovery) and a maximum score of 100 (best possible recovery).

  At postoperative 24th hours

Secondary Outcomes (1)

• Postoperative pain score, analgesic consumption

  At postoperative 24 hours (0, 2, 6,12,24)

Study Arms (3)

Group C (Control)

ACTIVE COMPARATOR

spinal anesthesia.

Other: Group C

Group T (Transversus Abdominis Plane Block)

ACTIVE COMPARATOR

The operation will be performed under spinal anesthesia and at the end of the operation, 20 ml of 0.25% bupivacaine will be applied bilaterally between the transverse abdominis muscle and the internal oblique muscle.

Other: Group T

Group W (Wound Infıltration)

ACTIVE COMPARATOR

The operation will be performed under spinal anesthesia and at the end of the operation, 20 ml of 0.25% bupivacaine will be applied wound infiltration

Other: Group W

Interventions

Group C OTHER

Spinal anesthesia.

Also known as: Control

Group C (Control)

Group T OTHER

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

Also known as: Transversus Abdominis Plane Block

Group T (Transversus Abdominis Plane Block)

Group W OTHER

spinal anesthesia and at the end of the surgery, 20 ml 0.25% bupivacaine will be applied to the wound site.

Also known as: Wound Infıltration

Group W (Wound Infıltration)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi Universıty Faculty of Medicine

Eskişehir, Eski̇şehi̇r, 26040, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 33370462 BACKGROUND

• 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.

  PMID: 31695991 BACKGROUND

• 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.

  PMID: 33368204 BACKGROUND

• 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.

  PMID: 32203873 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Meryem Onay

  Eskisehir Osmangazi University Faculty Of Medıcıne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meryem Onay

CONTACT

02222392979; dr.meryemonay@hotmail.com

Gülay ERDOĞAN KAYHAN

CONTACT

02222392979; drgulayer@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Anesthesiologist

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: May 16, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 5, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-04

Locations

TU (1)