Postoperative Pain ManagementQoR-TAPNCT07145619
Effect of Bilateral Ultrasound-Guided TAP Block on Quality of Recovery in Cesarean Delivery Patients Receiving Intrathecal Morphine
An observational study of Postoperative Pain Management and Obstetric Anesthesia, run by MEHMET GÖKHAN TAFLAN at 1 site in Turkey (Türkiye).
Trial summary
This prospective, assessor-blinded observational cohort study will investigate the effect of adding bilateral ultrasound-guided transversus abdominis plane (TAP) block to standard intrathecal morphine (ITM) analgesia on the quality of recovery in women undergoing elective cesarean delivery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain Management, Obstetric Anesthesia, Recovery From Anesthesia
- What is being tested?
- Spinal Anesthesia with Intrathecal Morphine Only and Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Jul 2026
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing elective cesarean delivery under spinal anesthesia with intrathecal morphine at a tertiary university hospital. Two observational cohorts will be followed: one receiving only intrathecal morphine and the other receiving intrathecal morphine plus bilateral ultrasound-guided TAP block.
Who may be able to join
- Female patients aged 18-45 years
- Singleton pregnancy
- ASA physical status II-III
- Scheduled elective lower segment cesarean delivery under spinal anesthesia with intrathecal morphine (ITM) as standard care
- Able to understand study procedures, provide written informed consent, and reliably use IV PCA
- Able to complete ObsQoR-10-T assessments (with trained assistance if needed)
Who cannot join
- Contraindication to spinal anesthesia or TAP block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
- Chronic opioid use or opioid/alfa-2 agonist intolerance
- Severe preeclampsia, HELLP syndrome, significant hepatic or renal impairment
- Urgent or emergent cesarean section (Category 1)
- Cognitive impairment or communication difficulty preventing accurate assessment
- Prior major abdominal surgery (other than previous cesarean delivery)
- Body mass index (BMI) > 40 kg/m²
- Major psychiatric illness (e.g., major depressive disorder, generalized anxiety disorder, psychosis) that may affect pain perception or quality of recovery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University Training and Research Hospital
Samsun, Samsun, 55090
About this study
Official title: Effect of Bilateral Ultrasound-Guided Transversus Abdominis Plane Block on Quality of Recovery in Cesarean Delivery Patients Receiving Intrathecal Morphine: A Prospective Observational Cohort Study
This prospective, assessor-blinded observational cohort study will investigate the effect of adding bilateral ultrasound-guided transversus abdominis plane (TAP) block to standard intrathecal morphine (ITM) analgesia on the quality of recovery in women undergoing elective cesarean delivery under spinal anesthesia. All participants will receive ITM as part of routine spinal anesthesia. The TAP group will receive an additional bilateral ultrasound-guided TAP block at the end of surgery, while the control group will not receive any additional block. Both groups will receive standardized postoperative analgesia with intravenous patient-controlled analgesia (IV PCA). The primary outcome is the quality of recovery at 24 hours postoperatively, measured using the validated Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. Secondary outcomes include Numerical Rating Scale (NRS) pain scores, time to first breastfeeding, time to mobilization, time to hospital discharge, and total opioid consumption in the first 24 hours after surgery. Outcome assessors will be blinded to group allocation. The study aims to determine whether TAP block enhances functional recovery, reduces pain, and decreases analgesic requirements when used alongside ITM in cesarean delivery patients.
Read the detailed description
Effective postoperative analgesia is essential for optimizing maternal recovery after cesarean delivery, promoting early mobilization, and supporting breastfeeding initiation. Spinal anesthesia with intrathecal morphine (ITM) is commonly used due to its long-lasting analgesia; however, it may not provide complete abdominal wall analgesia and can be associated with opioid-related side effects. The transversus abdominis plane (TAP) block is an ultrasound-guided regional anesthesia technique that provides somatic analgesia to the anterior abdominal wall by targeting the anterior rami of the thoracolumbar spinal nerves (T6-L1). When combined with ITM, TAP block may further improve recovery quality, reduce opioid requirements, and facilitate earlier return to daily activities.
In this prospective, assessor-blinded observational cohort study, all eligible patients undergoing elective cesarean delivery under spinal anesthesia at our institution will receive ITM as part of standard practice. Participants will be managed in two groups based on postoperative analgesia:
- TAP Group: Bilateral ultrasound-guided TAP block performed at the end of surgery in addition to ITM.
- Control Group: ITM only, without additional regional block.
Both groups will receive standardized postoperative analgesia via intravenous patient-controlled analgesia (IV PCA). Data will be collected prospectively, and the outcome assessor responsible for postoperative evaluation will be blinded to group allocation.
Primary Outcome:
- Quality of recovery at 24 hours postoperatively, measured using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire.
Secondary Outcomes:
- Numerical Rating Scale (NRS) pain scores
- Time to first breastfeeding
- Time to first mobilization
- Time to hospital discharge
- Total opioid consumption within the first 24 hours
By analyzing these parameters, the study aims to clarify whether the addition of TAP block to ITM-based analgesia can enhance recovery quality, improve functional outcomes, reduce pain intensity, and decrease opioid consumption in cesarean delivery patients. Findings from this research could inform best practice guidelines for postoperative pain management in obstetric anesthesia.
- Being tested
- Spinal Anesthesia with Intrathecal Morphine Only, Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block
- Keywords
- Cesarean delivery, Spinal anesthesia, Intrathecal morphine, Transversus abdominis plane block, Postoperative pain, Obstetric anesthesia, Quality of recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia with Intrathecal Morphine OnlyOther
Elective cesarean delivery performed under spinal anesthesia with the addition of 100 micrograms intrathecal morphine (ITM) as part of standard clinical care. No additional regional block is performed. Postoperative analgesia is maintained with intravenous patient-controlled analgesia (IV PCA) morphine and multimodal analgesia, including scheduled paracetamol and NSAIDs as per institutional protocol.
Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP BlockOther
Elective cesarean delivery performed under spinal anesthesia with the addition of 100 micrograms intrathecal morphine (ITM) as part of standard clinical care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. The TAP block will be performed in-plane with a high-frequency linear probe, using 0.25% bupivacaine, 20 mL per side, injected between the internal oblique and transversus abdominis muscles. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) morphine and multimodal analgesia, including scheduled paracetamol and NSAIDs.
| Study group | Role | What they receive |
|---|---|---|
| ITM | Patients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care. No additional regional block will be performed. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group Receives: Other: Spinal Anesthesia with Intrathecal Morphine Only | |
| ITM + TAP | Patients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group Receives: Other: Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric Quality of Recovery-10 (ObsQoR-10) Score at 24 Hours Postoperatively
Total score on the validated Turkish version of the Obstetric Quality of Recovery-10 questionnaire (ObsQoR-10-T), measured by a blinded assessor. Scores range from 0 to 100, with higher scores indicating better recovery.
Measured: 24 hours after surgery
Secondary outcomes (5)
Total Opioid Consumption in 24 Hours
Total intravenous morphine consumption (in milligrams) recorded from PCA device logs in the first 24 hours after surgery.
Measured: 0-24 hours postoperatively
Numerical Rating Scale (NRS) Pain Scores
Pain intensity measured using a Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at specified postoperative time points.
Measured: 0-24 hours postoperatively
Time to First Breastfeeding
Time interval in minutes from the completion of surgery to initiation of breastfeeding.
Measured: Assessed from end of surgery to first breastfeeding attempt, up to 24 hours
Time to First Mobilization
Time interval in hours from completion of surgery to the first mobilization with assistance or independently.
Measured: Assessed from the end of surgery to first mobilization attempt, up to 24 hours postoperatively
Time to Hospital Discharge
Time interval from the end of surgery until the patient is formally discharged from hospital care.
Measured: Assessed from the end of surgery to official hospital discharge, up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEHMET GÖKHAN TAFLAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MEHMET GÖKHAN TAFLAN, Samsun University
- Investigators
- Mehmet Gökhan Taflan, MD, Principal investigator, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145619
- Sponsor's protocol ID
- ITMTAPObsQoRMT2025
- Other IDs
- GOKAEK2024/18/8
- Acronym
- QoR-TAP
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), data dictionary, and statistical analysis code will be shared with qualified researchers upon reasonable request, after publication of the main results. Data will be available 12 months after study completion and for up to 5 years. Requests must be accompanied by a methodologically sound proposal and relevant ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Ultrasound-Guided Transversus Abdominis Plane Block on Quality of Recovery in Cesarean Delivery Patients Receiving Intrathecal Morphine: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07145619
- Acronym / sponsor ID
- QoR-TAP / ITMTAPObsQoRMT2025
- Keywords
- Cesarean delivery, Spinal anesthesia, Intrathecal morphine, Transversus abdominis plane block, Postoperative pain, Obstetric anesthesia, Quality of recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- MEHMET GÖKHAN TAFLANUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 28 Aug 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.
This prospective, assessor-blinded observational cohort study will investigate the effect of adding bilateral ultrasound-guided transversus abdominis plane (TAP) block to standard intrathecal morphine (ITM) analgesia on the quality of recovery in women undergoing elective cesarean delivery under spinal anesthesia. All participants will receive ITM as part of routine spinal anesthesia. The TAP group will receive an additional bilateral ultrasound-guided TAP block at the end of surgery, while the control group will not receive any additional block. Both groups will receive standardized postoperative analgesia with intravenous patient-controlled analgesia (IV PCA). The primary outcome is the quality of recovery at 24 hours postoperatively, measured using the validated Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. Secondary outcomes include Numerical Rating Scale (NRS) pain scores, time to first breastfeeding, time to mobilization, time to hospital discharge, and total opioid consumption in the first 24 hours after surgery. Outcome assessors will be blinded to group allocation. The study aims to determine whether TAP block enhances functional recovery, reduces pain, and decreases analgesic requirements when used alongside ITM in cesarean delivery patients.
Detailed description
Effective postoperative analgesia is essential for optimizing maternal recovery after cesarean delivery, promoting early mobilization, and supporting breastfeeding initiation. Spinal anesthesia with intrathecal morphine (ITM) is commonly used due to its long-lasting analgesia; however, it may not provide complete abdominal wall analgesia and can be associated with opioid-related side effects. The transversus abdominis plane (TAP) block is an ultrasound-guided regional anesthesia technique that provides somatic analgesia to the anterior abdominal wall by targeting the anterior rami of the thoracolumbar spinal nerves (T6-L1). When combined with ITM, TAP block may further improve recovery quality, reduce opioid requirements, and facilitate earlier return to daily activities.
In this prospective, assessor-blinded observational cohort study, all eligible patients undergoing elective cesarean delivery under spinal anesthesia at our institution will receive ITM as part of standard practice. Participants will be managed in two groups based on postoperative analgesia:
- TAP Group: Bilateral ultrasound-guided TAP block performed at the end of surgery in addition to ITM.
- Control Group: ITM only, without additional regional block.
Both groups will receive standardized postoperative analgesia via intravenous patient-controlled analgesia (IV PCA). Data will be collected prospectively, and the outcome assessor responsible for postoperative evaluation will be blinded to group allocation.
Primary Outcome:
- Quality of recovery at 24 hours postoperatively, measured using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire.
Secondary Outcomes:
- Numerical Rating Scale (NRS) pain scores
- Time to first breastfeeding
- Time to first mobilization
- Time to hospital discharge
- Total opioid consumption within the first 24 hours
By analyzing these parameters, the study aims to clarify whether the addition of TAP block to ITM-based analgesia can enhance recovery quality, improve functional outcomes, reduce pain intensity, and decrease opioid consumption in cesarean delivery patients. Findings from this research could inform best practice guidelines for postoperative pain management in obstetric anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITM | – | Other: Spinal Anesthesia with Intrathecal Morphine OnlyPatients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care. No additional regional block will be performed. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group |
| ITM + TAP | – | Other: Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP BlockPatients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing elective cesarean delivery under spinal anesthesia with intrathecal morphine at a tertiary university hospital. Two observational cohorts will be followed: one receiving only intrathecal morphine and the other receiving intrathecal morphine plus bilateral ultrasound-guided TAP block.
Key inclusion criteria (6 listed)
- Female patients aged 18-45 years
- Singleton pregnancy
- ASA physical status II-III
- Scheduled elective lower segment cesarean delivery under spinal anesthesia with intrathecal morphine (ITM) as standard care
- Able to understand study procedures, provide written informed consent, and reliably use IV PCA
Key exclusion criteria (8 listed)
- Contraindication to spinal anesthesia or TAP block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
- Chronic opioid use or opioid/alfa-2 agonist intolerance
- Severe preeclampsia, HELLP syndrome, significant hepatic or renal impairment
- Urgent or emergent cesarean section (Category 1)
- Cognitive impairment or communication difficulty preventing accurate assessment
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 |
|---|---|---|
| Spinal Anesthesia with Intrathecal Morphine OnlyElective cesarean delivery performed under spinal anesthesia with the addition of 100 micrograms intrathecal morphine (ITM) as part of standard clinical care. No additional regional block is performed. Postoperative analgesia is maintained with intravenous patient-controlled analgesia (IV PCA) morphine and multimodal analgesia, including scheduled paracetamol and NSAIDs as per institutional protocol. | Other | ITM |
| Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP BlockElective cesarean delivery performed under spinal anesthesia with the addition of 100 micrograms intrathecal morphine (ITM) as part of standard clinical care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. The TAP block will be performed in-plane with a high-frequency linear probe, using 0.25% bupivacaine, 20 mL per side, injected between the internal oblique and transversus abdominis muscles. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) morphine and multimodal analgesia, including scheduled paracetamol and NSAIDs. | Other | ITM + TAP |
Primary outcome
Obstetric Quality of Recovery-10 (ObsQoR-10) Score at 24 Hours Postoperatively
Time frame: 24 hours after surgery
Total score on the validated Turkish version of the Obstetric Quality of Recovery-10 questionnaire (ObsQoR-10-T), measured by a blinded assessor. Scores range from 0 to 100, with higher scores indicating better recovery.
5 secondary outcomes
Total Opioid Consumption in 24 Hours
Time frame: 0-24 hours postoperatively
Numerical Rating Scale (NRS) Pain Scores
Time frame: 0-24 hours postoperatively
Time to First Breastfeeding
Time frame: Assessed from end of surgery to first breastfeeding attempt, up to 24 hours
Time to First Mobilization
Time frame: Assessed from the end of surgery to first mobilization attempt, up to 24 hours postoperatively
Time to Hospital Discharge
Time frame: Assessed from the end of surgery to official hospital discharge, up to 7 days postoperatively
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 4 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), data dictionary, and statistical analysis code will be shared with qualified researchers upon reasonable request, after publication of the main results. Data will be available 12 months after study completion and for up to 5 years. Requests must be accompanied by a methodologically sound proposal and relevant ethics approval.
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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.
Mehmet Gökhan Taflan, MD principal investigator
Samsun Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain Management and Obstetric Anesthesia, run by MEHMET GÖKHAN TAFLAN 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 6 inclusion and 8 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 4 Aug 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 (ObsQoR-10) Score at 24 Hours Postoperatively (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.