Pain, PostoperativeNCT06978491
Evaluation of the Effect of Postoperative Analgesia Techniques With ObsQoR-10
A study testing Group C, Group T and Group W in people with Pain, Postoperative and Postoperative Complications, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Postoperative Complications
- What is being tested?
- Group C, Group T and Group W
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2025to 14 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi Universıty Faculty of Medicine
Eskişehir, Eski̇şehi̇r, 26040
About this study
Official title: Evaluation of the Effect of Postoperative Analgesia Techniques on Obstetric Recovery Quality 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.
Read the 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.
- Conditions
- Pain, Postoperative, Postoperative Complications
- Being tested
- Group C, Group T, Group W
- Keywords
- cesarean section, postoperative analgesia, Quality of recovery
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group COther
Also called Control
Spinal anesthesia.
Group TOther
Also called Transversus Abdominis Plane Block
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 WOther
Also called Wound Infıltration
spinal anesthesia and at the end of the surgery, 20 ml 0.25% bupivacaine will be applied to the wound site.
| Study group | Role | What they receive |
|---|---|---|
| Group C (Control) | Active comparator | spinal anesthesia. Receives: 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. Receives: 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 Receives: Other: Group W |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At postoperative 24th hours
Secondary outcomes (1)
Postoperative pain score, analgesic consumption
Numeric rating scale pain from 0 (no pain) to 10 (worst pain).
Measured: At postoperative 24 hours (0, 2, 6,12,24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start16 May 2025
- Primary completion14 May 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Onay, Eskisehir Osmangazi University
- Investigators
- Meryem Onay, Principal investigator, Eskisehir Osmangazi University Faculty Of Medıcıne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978491
- Sponsor's protocol ID
- ESOGU 6
- Status last verified
- May 2026
- First submitted
- 11 May 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33370462Nasir 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.
PubMed 31695991Riemma 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.
PubMed 33368204Sultan 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.
PubMed 32203873
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Postoperative Analgesia Techniques on Obstetric Recovery Quality With ObsQoR-10
- ClinicalTrials.gov ID
- NCT06978491
- Acronym / sponsor ID
- ESOGU 6
- Conditions
- Pain, Postoperative, Postoperative Complications
- Keywords
- cesarean section, postoperative analgesia, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group C (Control) | Active comparator | Other: Group Cspinal anesthesia. |
| Group T (Transversus Abdominis Plane Block) | Active comparator | Other: Group TThe 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 W (Wound Infıltration) | Active comparator | Other: Group WThe 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group CAlso: ControlSpinal anesthesia. | Other | Group C (Control) |
| Group TAlso: Transversus Abdominis Plane Blockspinal 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 | Group T (Transversus Abdominis Plane Block) |
| Group WAlso: Wound Infıltrationspinal anesthesia and at the end of the surgery, 20 ml 0.25% bupivacaine will be applied to the wound site. | Other | Group W (Wound Infıltration) |
Primary outcome
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).
1 secondary outcome
Postoperative pain score, analgesic consumption
Time frame: At postoperative 24 hours (0, 2, 6,12,24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 33370462Roofthooft 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.
- Background: PubMed 31695991Nasir 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.
- Background: PubMed 33368204Riemma 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.
- Background: PubMed 32203873Sultan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Onay principal investigator
Eskisehir Osmangazi University Faculty Of Medıcıne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group C, Group T and Group W in people with Pain, Postoperative and Postoperative Complications, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric Quality of Recovery-10 (time frame: At postoperative 24th hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06978491, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.