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

NCT ID: NCT06978491

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2025-10-05

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group C (Control)

spinal anesthesia.

Group Type ACTIVE_COMPARATOR

Group C

Intervention Type OTHER

Spinal anesthesia.

Group T (Transversus Abdominis Plane Block)

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.

Group Type ACTIVE_COMPARATOR

Group T

Intervention Type 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.

Group W (Wound Infıltration)

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

Group Type ACTIVE_COMPARATOR

Group W

Intervention Type OTHER

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

Interventions

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Group C

Spinal anesthesia.

Intervention Type OTHER

Group 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.

Intervention Type OTHER

Group W

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

Intervention Type OTHER

Other Intervention Names

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Control Transversus Abdominis Plane Block Wound Infıltration

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Meryem Onay

Associate professor, Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meryem Onay

Role: PRINCIPAL_INVESTIGATOR

Eskisehir Osmangazi University Faculty Of Medıcıne

Locations

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Eskisehir Osmangazi Universıty Faculty of Medicine

Eskişehir, Eski̇şehi̇r, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Meryem Onay

Role: CONTACT

02222392979 ext. 5010

Gülay ERDOĞAN KAYHAN

Role: CONTACT

02222392979

Facility Contacts

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Meryem Onay

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33370462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31695991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33368204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32203873 (View on PubMed)

Other Identifiers

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ESOGU 6

Identifier Type: -

Identifier Source: org_study_id

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