Postoperative RecoveryNCT05999981
Comparison of the Quality of Recovery After Cesarean Section Surgery
A study testing Transversalis Fascia Plane Block and Transversus Abdominis Plane Block in people with Postoperative Recovery and Abdominal Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Inadequate pain control after cesarean section surgery causes postpartum depression, persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block would improve postoperative quality of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Recovery, Abdominal Pain, Cesarean Section
- What is being tested?
- Transversalis Fascia Plane Block and Transversus Abdominis Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Aug 2023to 2 Nov 2023
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status II-III
- Cesarean section surgery under spinal anesthesia
Who cannot join
- American Society of Anesthesiologists physical status IV
- Emergency surgery
- General anesthesia
- Additional surgical intervention at the same session
- Body mass index of more than 35 kg/m2
- Allergy to any study drugs
Show all 11Show fewer
- Local infection at the injection site
- History of drug abuse
- Communication problem
- Coagulopathy
- Preeclampsia and eclampsia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Training and Research Hospital
Muğla
About this study
Official title: Comparison Between Ultrasound Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Recovery in Patients Undergoing Cesarean Section Surgery
Inadequate pain control after cesarean section surgery causes postpartum depression, persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid consumption after cesarean section surgery.
- Conditions
- Postoperative Recovery, Abdominal Pain, Cesarean Section
- Being tested
- Transversalis Fascia Plane Block, Transversus Abdominis Plane Block
- Keywords
- cesarean section surgery, postoperative recovery, postoperative pain, trasversalis fascia plane block, transversus abdominis plane block, obstetric quality of recovery 11 Turkish score, numeric rating scale
- Medical subject headings
- Abdominal Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis Fascia Plane BlockProcedure or surgery
40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally
Transversus Abdominis Plane BlockProcedure or surgery
40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Transversalis Fascia Plane Block (TFPB) Group | Active comparator | At TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally. Receives: Procedure: Transversalis Fascia Plane Block |
| Transversus Abdominis Plane (TAP) Block Group | Active comparator | At TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally. Receives: Procedure: Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative quality of recovery
Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score
Measured: Postoperative 24th hour
Secondary outcomes (3)
Postoperative opioid consumption
Morphine consumption will be assessed by checking patient controlled analgesia (PCA) device records and fentanyl consumption will be assessed by checking patient daily drug order records
Measured: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Numeric Rating Scale
A blinded nurse will assess postoperative pain during resting and movement at postoperative 1st, 2nd, 4th, 8th 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable)
Measured: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Adverse Reactions
Nausea, vomiting, constipation, urinary retention and skin rash/pruritus will be assessed
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start24 Aug 2023
- Primary completion1 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative RecoveryStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Korkmaz Toker, Muğla Sıtkı Koçman University
- Investigators
- Melike Korkmaz Toker, Associate Professor, Principal investigator, Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999981
- Sponsor's protocol ID
- MSKU 13-IV
- Status last verified
- Nov 2023
- First submitted
- 14 Aug 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: via mail
Publications
Jadon A, Jain P, Chakraborty S, Motaka M, Parida SS, Sinha N, Agrawal A, Pati AK. Role of ultrasound guided transversus abdominis plane block as a component of multimodal analgesic regimen for lower segment caesarean section: a randomized double blind clinical study. BMC Anesthesiol. 2018 May 14;18(1):53. doi: 10.1186/s12871-018-0512-x.
PubMed 29759061Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
PubMed 32412986Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.
PubMed 39039833
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Recovery in Patients Undergoing Cesarean Section Surgery
- ClinicalTrials.gov ID
- NCT05999981
- Acronym / sponsor ID
- MSKU 13-IV
- Conditions
- Postoperative Recovery, Abdominal Pain, Cesarean Section
- Keywords
- cesarean section surgery, postoperative recovery, postoperative pain, trasversalis fascia plane block, transversus abdominis plane block, obstetric quality of recovery 11 Turkish score, numeric rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 21 Aug 2023 (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.
Inadequate pain control after cesarean section surgery causes postpartum depression, persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid consumption after cesarean section surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversalis Fascia Plane Block (TFPB) Group | Active comparator | Procedure: Transversalis Fascia Plane BlockAt TFPB group, the block will be performed by ultrasound guidance after completion of surgery. TFPB will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TFPB group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses between transversus abdominis muscle and transversalis fascia bilaterally. |
| Transversus Abdominis Plane (TAP) Block Group | Active comparator | Procedure: Transversus Abdominis Plane BlockAt TAP block group, the block will be performed by ultrasound guidance after completion of surgery. TAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 megahertz ultrasound probe by the anesthesiologist. In TAP block group patients will receive 40 ml %0.25 bupivacaine divided into 2 equal doses in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status II-III
- Cesarean section surgery under spinal anesthesia
Key exclusion criteria (11 listed)
- American Society of Anesthesiologists physical status IV
- Emergency surgery
- General anesthesia
- Additional surgical intervention at the same session
- Body mass index of more than 35 kg/m2
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 |
|---|---|---|
| Transversalis Fascia Plane Block40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance between transversus abdominis muscle and transversalis fascia bilaterally | Procedure or surgery | Transversalis Fascia Plane Block (TFPB) Group |
| Transversus Abdominis Plane Block40 ml %0.25 bupivacaine divided into 2 equal doses will be injected by the anesthesiologist under ultrasonography guidance in the fascial plane between internal oblique muscle and transversus abdominis muscle bilaterally | Procedure or surgery | Transversus Abdominis Plane (TAP) Block Group |
Primary outcome
Postoperative quality of recovery
Time frame: Postoperative 24th hour
Postoperative quality of recovery will be assessed by Obstetric Quality of Recovery 11 Turkish (ObsQoR-11T) score
3 secondary outcomes
Postoperative opioid consumption
Time frame: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Numeric Rating Scale
Time frame: Postoperative 1st, 2nd, 4th, 8th 12th and 24th hour
Adverse Reactions
Time frame: Postoperative 24th hour
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 13 Nov 2023.
- Background: PubMed 29759061Jadon A, Jain P, Chakraborty S, Motaka M, Parida SS, Sinha N, Agrawal A, Pati AK. Role of ultrasound guided transversus abdominis plane block as a component of multimodal analgesic regimen for lower segment caesarean section: a randomized double blind clinical study. BMC Anesthesiol. 2018 May 14;18(1):53. doi: 10.1186/s12871-018-0512-x.
- Background: PubMed 32412986Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
- Derived from this study: PubMed 39039833Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.
- Individual participant dataSharing planned: No. via mail
Related trials for Postoperative Recovery
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
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.
Melike Korkmaz Toker, Associate Professor principal investigator
Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversalis Fascia Plane Block and Transversus Abdominis Plane Block in people with Postoperative Recovery and Abdominal Pain, run by Muğla Sıtkı Koçman 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 2 inclusion and 11 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 13 Nov 2023. 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?
Postoperative quality of recovery (time frame: Postoperative 24th hour). 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 NCT05999981, which also lists 3 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 13 Nov 2023.