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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06978491
Enrollment
75
Registered
2025-05-18
Start date
2025-05-16
Completion date
2026-05-14
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Postoperative Complications

Keywords

cesarean section, postoperative analgesia, Quality of recovery

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.

Interventions

OTHERGroup C

Spinal anesthesia.

OTHERGroup T

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.

OTHERGroup W

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

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Obstetric Quality of Recovery-10At postoperative 24th hoursThe 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

MeasureTime frameDescription
Postoperative pain score, analgesic consumptionAt postoperative 24 hours (0, 2, 6,12,24)Numeric rating scale pain from 0 (no pain) to 10 (worst pain).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORMeryem Onay

Eskisehir Osmangazi University Faculty Of Medıcıne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026