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Completed

NCT Number: NCT06978491

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi Universıty Faculty of Medicine

Eskişehir, Eski̇şehi̇r, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group C

Other

Spinal anesthesia.

Other names: 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.

Other names: 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.

Other names: Wound Infıltration

Primary outcomes

  1. Obstetric Quality of Recovery-10

    Time frame: At postoperative 24th hours

    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).

Secondary outcomes

  1. Postoperative pain score, analgesic consumption

    Time frame: At postoperative 24 hours (0, 2, 6,12,24)

    Numeric rating scale pain from 0 (no pain) to 10 (worst pain).

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Evaluation of the Effect of Postoperative Analgesia Techniques on Obstetric Recovery Quality With ObsQoR-10

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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