Postoperative PainNCT07604376
Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2%
A study testing Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side and Postoperative pain management using "traditional" analgesia iv regime in people with Postoperative Pain and Postoperative Acute Pain, run by Matild Keresztes at 1 site in Romania.
Trial summary
The goal of this clinical trial is to evaluate whether the addition of a Transversus Abdominis Plane (TAP) block improves postoperative outcomes in women undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Postoperative Acute Pain
- What is being tested?
- Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side and Postoperative pain management using "traditional" analgesia iv regime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteRomania
- Study dates
- 1 Mar 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant patient anaesthesia type for c-section: spinal
Who cannot join
- general anaesthesia for c-section combined spinal/epidural anaethesia for c-section hipertensive emergencies in obstetrics haemorrhage emergencies in obstetrics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
County Emergency Clinical Hospital of Targu Mureș
Târgu Mureş, Mureș County, 547581
Matild Keresztes, MD, 0741784066, keresztesmatild@gmail.com
Janos Szederjesi, MD, PhD Assoc Prof, yangzi37@gmail.com
About this study
The goal of this clinical trial is to evaluate whether the addition of a Transversus Abdominis Plane (TAP) block improves postoperative outcomes in women undergoing cesarean section.
The main questions it aims to answer are:
Read more
Does the TAP block reduce postoperative pain scores compared with the traditional analgesic regimen used in our hospital? Does the TAP block decrease opioid consumption within the first 24 hours? Does the TAP block improve the 24-hour quality of recovery? Researchers will compare patients receiving the traditional analgesic regimen with patients who receive the TAP block in addition to standard care to determine differences in pain management, opioid requirements, and recovery quality.
Participants will:
Receive standard anesthetic and perioperative care for cesarean delivery. Be randomized to either the TAP block group or the traditional analgesic regimen group.
Have postoperative pain scores assessed at predefined intervals. Have opioid consumption recorded within the first 24 hours. Complete a quality-of-recovery assessment at 24 hours postoperatively.
Read the detailed description
This study will evaluate the effectiveness of a Transversus Abdominis Plane (TAP) block for postoperative analgesia in patients undergoing cesarean section.
Participants randomized to the TAP group will receive an ultrasound-guided TAP block with ropivacaine 0.2% at a dose of 0.4 ml/kg per side. The block will be performed at the end of surgery, under spinal anesthesia, using a linear probe with a lateral approach. After aseptic preparation of the skin, sterile probe covering, and operator sterile technique, the muscle layers will be identified sonographically. A 50 mm or 100 mm needle will be inserted in-plane. Following confirmation of the fascial plane and negative aspiration for blood, local anesthetic will be administered in 5 ml increments, with repeated aspiration to avoid intravascular injection.
Postoperative analgesia in the TAP group will consist of ibuprofen every 8 hours (max 1200mg/day) and paracetamol every 6-8 hours (max 4 gr/day), with tramadol 50 mg available as rescue analgesic.
Participants in the control group (non-TAP) will receive the traditional analgesic regimen used in our hospital: metamizole every 8 hours ( max 3 gr/day), NSAIDs (ibuprofen, dexketoprofen, pareecoxib), paracetamol every 6-8 hours ( max 4 gr/day), and scheduled tramadol, every 8-12 hour ( max 300 mg/day)
Pain assessment and outcomes:
Participants will remain in the obstetric intensive care unit (ICU) for the first 12-24 hours after cesarean delivery, after which they will be transferred to the ward.
Pain will be assessed using the Numeric Rating Scale (NRS) at rest, during mobilization, during breastfeeding, and while standing/walking. The target NRS is ≤4.
Opioid consumption will be recorded during the first 24 hours.
Quality of recovery:
At 24 hours postoperatively, participants will complete the ObsQoR-11 questionnaire, a validated recovery tool consisting of 11 statements.
It comprises 11 items that assess recovery across the key domains of physical comfort, physical independence, psychological well-being, emotional state, and pain control.
Each item is rated by the patient on a 0-10 numerical rating scale, where 0 corresponds to the poorest recovery or complete disagreement with the statement, and 10 corresponds to the best possible recovery or complete agreement with the statement.
The individual item scores are summed to yield a total score ranging from 0 to 110, with higher scores reflecting a better quality of postoperative recovery. The ObsQoR-11 therefore provides a quantitative, standardized, and patient-centered measure of recovery, allowing for both within-group and between-group comparisons in clinical trials.
- Conditions
- Postoperative Pain, Postoperative Acute Pain
- Being tested
- Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side, Postoperative pain management using "traditional" analgesia iv regime
- Keywords
- obstetric, c-section, TAP block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per sideDrug
Also called TAP block
Postoperative (post cesarean section) TAP block using low concentration Ropivacaine ( 0,2%), volume dose weight calculated: 0,4 ml/kg per side. Total ropivacaine dose 1,6 mg/kg.
Postoperative pain management using "traditional" analgesia iv regimeDrug
"Traditional" analgesia refers to our analgesia technique used in our hospital. Regular Tramadol, Metamizol, +/- Ibuprofen/Dexketorpofen/Parecoxib
| Study group | Role | What they receive |
|---|---|---|
| Postoperative (c-section) TAP block | Active comparator | Post c-section TAP block under spinal anaesthesia. Local anesthetic used in TAP block: Ropivacaine 0,2 %, dose: 0,4 ml/kg per side. Postoperative analgesia regimen: Ibuprofen every 8 hours (total dose 1200 mg/24h) and Paracetamol every 6-8 hours (total dose 4 gr/24 h). Postop analgesia score: numeric rating scale ( 0-10). Rescue analgesia if score is higher then 4: tramadol 50 mg, diluated in 20 ml NaCl 0,9%, administered slow iv ( 5 min). Receives: Drug: Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side |
| "Traditional" analgesia regimen after c-section | Other | This arm receives the "traditional" analgesia regimen used in our hospital. This analgesia consist of: metamizol 1 gr every 8 hours, paracetamol 1gr every 8 hours, Ibuprofen every 8 hours or dexketoprofen 50 mg every 12 hours or parecoxib 40 mg every 12 hours. The use of NSAID are not mandatory and is doctor dependent. In the traditional analgesia regime we have regular opioids: tramadol 100 mg every 8-12 hours. We assess the pain scores using numeric rating scale (0-10). If pain persist usually rescue analgesia is a second opiod: meperidine 15-20 mg iv. Receives: Drug: Postoperative pain management using "traditional" analgesia iv regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Measured: 24 hours
Secondary outcomes (1)
Recovery after cesarean section using the ObsQoR-11
The ObsQoR-11 is an 11-item, self-report questionnaire used to assess recovery after childbirth, particularly caesarean delivery after 24 hours. It measures four key aspects of recovery: physical comfort, emotional state, physical independence, and the ability to care for the newborn. A higher ObsQoR-11 score indicates better recovery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Mar 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matild Keresztes
- Sponsor type
- University, hospital or other
- Collaborators
- Tîrgu Mureș Emergency Clinical County Hospital, Romania
- Responsible party
- Sponsor-investigator, Matild Keresztes, Tîrgu Mureș Emergency Clinical County Hospital, Romania
- Investigators
- Janos Szederjesi, MD, PhD Assoc Prof, Study director, Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu MureșMatild Keresztes, Principal investigator, Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604376
- Sponsor's protocol ID
- 7633/18.04.2024
- Other IDs
- 7633/18.04.2024
- Status last verified
- Oct 2025
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2%
- ClinicalTrials.gov ID
- NCT07604376
- Acronym / sponsor ID
- 7633/18.04.2024
- Conditions
- Postoperative Pain, Postoperative Acute Pain
- Keywords
- obstetric, c-section, TAP block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Matild KeresztesUniversity, hospital or other
- Collaborators
- Tîrgu Mureș Emergency Clinical County Hospital, Romania
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2026 (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 goal of this clinical trial is to evaluate whether the addition of a Transversus Abdominis Plane (TAP) block improves postoperative outcomes in women undergoing cesarean section.
The main questions it aims to answer are:
Does the TAP block reduce postoperative pain scores compared with the traditional analgesic regimen used in our hospital? Does the TAP block decrease opioid consumption within the first 24 hours? Does the TAP block improve the 24-hour quality of recovery? Researchers will compare patients receiving the traditional analgesic regimen with patients who receive the TAP block in addition to standard care to determine differences in pain management, opioid requirements, and recovery quality.
Participants will:
Receive standard anesthetic and perioperative care for cesarean delivery. Be randomized to either the TAP block group or the traditional analgesic regimen group.
Have postoperative pain scores assessed at predefined intervals. Have opioid consumption recorded within the first 24 hours. Complete a quality-of-recovery assessment at 24 hours postoperatively.
Detailed description
This study will evaluate the effectiveness of a Transversus Abdominis Plane (TAP) block for postoperative analgesia in patients undergoing cesarean section.
Participants randomized to the TAP group will receive an ultrasound-guided TAP block with ropivacaine 0.2% at a dose of 0.4 ml/kg per side. The block will be performed at the end of surgery, under spinal anesthesia, using a linear probe with a lateral approach. After aseptic preparation of the skin, sterile probe covering, and operator sterile technique, the muscle layers will be identified sonographically. A 50 mm or 100 mm needle will be inserted in-plane. Following confirmation of the fascial plane and negative aspiration for blood, local anesthetic will be administered in 5 ml increments, with repeated aspiration to avoid intravascular injection.
Postoperative analgesia in the TAP group will consist of ibuprofen every 8 hours (max 1200mg/day) and paracetamol every 6-8 hours (max 4 gr/day), with tramadol 50 mg available as rescue analgesic.
Participants in the control group (non-TAP) will receive the traditional analgesic regimen used in our hospital: metamizole every 8 hours ( max 3 gr/day), NSAIDs (ibuprofen, dexketoprofen, pareecoxib), paracetamol every 6-8 hours ( max 4 gr/day), and scheduled tramadol, every 8-12 hour ( max 300 mg/day)
Pain assessment and outcomes:
Participants will remain in the obstetric intensive care unit (ICU) for the first 12-24 hours after cesarean delivery, after which they will be transferred to the ward.
Pain will be assessed using the Numeric Rating Scale (NRS) at rest, during mobilization, during breastfeeding, and while standing/walking. The target NRS is ≤4.
Opioid consumption will be recorded during the first 24 hours.
Quality of recovery:
At 24 hours postoperatively, participants will complete the ObsQoR-11 questionnaire, a validated recovery tool consisting of 11 statements.
It comprises 11 items that assess recovery across the key domains of physical comfort, physical independence, psychological well-being, emotional state, and pain control.
Each item is rated by the patient on a 0-10 numerical rating scale, where 0 corresponds to the poorest recovery or complete disagreement with the statement, and 10 corresponds to the best possible recovery or complete agreement with the statement.
The individual item scores are summed to yield a total score ranging from 0 to 110, with higher scores reflecting a better quality of postoperative recovery. The ObsQoR-11 therefore provides a quantitative, standardized, and patient-centered measure of recovery, allowing for both within-group and between-group comparisons in clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative (c-section) TAP block | Active comparator | Drug: Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per sidePost c-section TAP block under spinal anaesthesia. Local anesthetic used in TAP block: Ropivacaine 0,2 %, dose: 0,4 ml/kg per side. Postoperative analgesia regimen: Ibuprofen every 8 hours (total dose 1200 mg/24h) and Paracetamol every 6-8 hours (total dose 4 gr/24 h). Postop analgesia score: numeric rating scale ( 0-10). Rescue analgesia if score is higher then 4: tramadol 50 mg, diluated in 20 ml NaCl 0,9%, administered slow iv ( 5 min). |
| "Traditional" analgesia regimen after c-section | Other | Drug: Postoperative pain management using "traditional" analgesia iv regimeThis arm receives the "traditional" analgesia regimen used in our hospital. This analgesia consist of: metamizol 1 gr every 8 hours, paracetamol 1gr every 8 hours, Ibuprofen every 8 hours or dexketoprofen 50 mg every 12 hours or parecoxib 40 mg every 12 hours. The use of NSAID are not mandatory and is doctor dependent. In the traditional analgesia regime we have regular opioids: tramadol 100 mg every 8-12 hours. We assess the pain scores using numeric rating scale (0-10). If pain persist usually rescue analgesia is a second opiod: meperidine 15-20 mg iv. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant patient anaesthesia type for c-section: spinal
Key exclusion criteria (1 listed)
- general anaesthesia for c-section combined spinal/epidural anaethesia for c-section hipertensive emergencies in obstetrics haemorrhage emergencies in obstetrics
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 |
|---|---|---|
| Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per sideAlso: TAP blockPostoperative (post cesarean section) TAP block using low concentration Ropivacaine ( 0,2%), volume dose weight calculated: 0,4 ml/kg per side. Total ropivacaine dose 1,6 mg/kg. | Drug | Postoperative (c-section) TAP block |
| Postoperative pain management using "traditional" analgesia iv regime"Traditional" analgesia refers to our analgesia technique used in our hospital. Regular Tramadol, Metamizol, +/- Ibuprofen/Dexketorpofen/Parecoxib | Drug | "Traditional" analgesia regimen after c-section |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hours
1 secondary outcome
Recovery after cesarean section using the ObsQoR-11
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes
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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.
Janos Szederjesi, MD, PhD Assoc Prof study director
Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș
Matild Keresztes principal investigator
Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side and Postoperative pain management using "traditional" analgesia iv regime in people with Postoperative Pain and Postoperative Acute Pain, run by Matild Keresztes at 1 site in Romania.
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 1 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: looking for participants now, as of the sponsor's last update on 22 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 Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matild Keresztes, Medical doctor (+40741784066, keresztesmatild@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 24 hours). 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 22 May 2026.