Cesarean SectionNCT06078475
Efficacy of Modified Perichondral Approach Thoracoabdominal Nerve Block For Post Cesarean Section
A study testing Postoperative analgesia management in people with Cesarean Section, run by Bursa City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Cesarean section (CS) is one of the most frequently performed surgical procedures in the World. Moderate to severe postoperative pain occurs in a significant proportion of women after cesarean surgery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Postoperative analgesia management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 15 May 2024
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification II
- Elective cesarean section, and gestational age above 37 weeks will be included
Who cannot join
- Bleeding diathesis
- Anticoagulant treatment
- Local anesthetics and opioid allergy
- Infection at the site of block
- Patients who do not accept the procedure
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi
Bursa, 16110
Mursel Ekinci, +905067137596 ext. 3665, drmurselekinci@gmail.com
+90.224 975 00 00
- Recruiting
Mursel Ekinci
Bursa
MÜRSEL EKİNCİ, 05067137596, drmurselekinci@gmail.com
AHMET KACIROGLU
About this study
Official title: Efficacy Of Modified Perichondral Approach Thoracoabdominal Nerve Block For Post Cesarean Section Pain
Cesarean section (CS) is one of the most frequently performed surgical procedures in the World. Moderate to severe postoperative pain occurs in a significant proportion of women after cesarean surgery.
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a novel technique that provides effective analgesia in the anterior and lateral thoracoabdominal areas, where local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral Wall, provides analgesia in the abdominal area at the T5-T11 level.
The aim of this study is to evaluate the effectiveness of US-guided M-TAPA block for postoperative analgesia management after cesarean section.
Read the detailed description
Cesarean section (CS) is one of the most frequently performed surgical procedures in the World, in European countries, approximately 20% of deliveries are CS. Moderate to severe postoperative pain occurs in a significant proportion of women after cesarean surgery. This delays recovery and returning to daily life. Postoperative pain disrupts the mother-child bond, makes breastfeeding difficult, and affects the psychological state of the mother. Also inadequate postoperative analgesia may cause hyperalgesia and chronic pain.
Perioperative pain should be managed with a multi-modal approach. Opioids and nonsteroid anti inflammatory drugs should be considered as components of a multimodal analgesic regimen. However, use of both systemic and neuraxial opioids may be associated with effects (respiratory depression, nausea, vomiting, sedation, pruritus, hyperalgesia). For this, interfacial blocks may be preffered to provide postoperative analgesia and reduced opioid consumption.
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a novel technique that provides effective analgesia in the anterior and lateral thoracoabdominal areas, where local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral Wall, provides analgesia in the abdominal area at the T5-T11 level. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen under US guidance.
In the literature, there are studies investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery. However, there is no randomized study evaluating the effectiveness of M-TAPA block for postoperative analgesia management after CS. The aim of this study is to evaluate the effectiveness of US-guided M-TAPA block for postoperative analgesia management after cesarean section. The primary outcome is to compare global recovery scores, the secondary outcome is to compare postoperative pain scores (NRS), to evaluate postoperative rescue analgesic (opioid) use and side effects (allergic reaction, nausea, vomiting) associated with opioid use in this study.
- Conditions
- Cesarean Section
- Being tested
- Postoperative analgesia management
- Keywords
- Cesarean Section Pain, Postoperative Analgesia, Modified Perichondral Approach Thoracoabdominal Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative analgesia managementOther
Patients will be administered paracetamol 1 gr (PERFALGAN® ) IV every 8 hours in the postoperative period.. If the patient's NRS score is ≥ 4 0,5 mg/kg IV meperidine (Aldolan ampul 100 mg/2 ml) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group) | Active comparator | In group M-TAPA, M-TAPA block will be performed with patient is in the supine position. After providing aseptic conditions, the high frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed in the sagittal plane where the midclavicular line intersects with the costal cartilage corresponding to the costochondral angle. Using the In Plane technique, the probe is gently pushed to visualize the lower part of the costochondral angle at the central level, advancing the block needle in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage, and the block location will be confirmed. After the block location is confirmed, a total of 20 ml + 20 ml of 0.25% bupivacaine(Buvasin %5 flakon) (total 40 ml for both sides) will be injected bilaterally. Receives: Other: Postoperative analgesia management |
| Group C (Control group) | Active comparator | In the control group, analgesics will be administered according to the protocol in postoperative analgesia management. Receives: Other: Postoperative analgesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global recovery scoring system (patient satisfaction scale)
We will use the Turkish version of Quality of Recovery / QoR-15 questionairre
PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent])
- Able to breathe easily
- Been able to enjoy food
- Feeling rested
- Have had a good sleep
- Able to look after personal toilet and hygiene unaided
- Able to communicate with
- Getting support from hospital doctors and nurses
- Able to return to work or usual home activities
- Feeling comfortable and in control
- Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor])
- Moderate pain
- Severe pain
- Nausea or vomiting
- Feeling worried or anxious
- Feeling sad or depressed
Measured: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
Secondary outcomes (2)
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.
Measured: Patients will be evaluated at the first 24 hours period postoperatively.
The use of rescue analgesia
The need for rescue analgesia will be recorded at the first 24 hours period postoperatively.
Measured: Meperidine consumption will be recorded at the first 24 hours period postoperatively. (Number of Participants and Concentration of Meperidin)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Oct 2023
- Primary completion15 Feb 2024
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies 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
- There are two models for this study. Modified Perichondral Approach Thoracoabdominal Nerve block (M-TAPA block) group, and Control (C) group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mursel Ekinci, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078475
- Sponsor's protocol ID
- Bursa City Hospital 3
- Status last verified
- Apr 2024
- First submitted
- 25 Jul 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
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.
PubMed 33368204Kintu A, Abdulla S, Lubikire A, Nabukenya MT, Igaga E, Bulamba F, Semakula D, Olufolabi AJ. Postoperative pain after cesarean section: assessment and management in a tertiary hospital in a low-income country. BMC Health Serv Res. 2019 Jan 25;19(1):68. doi: 10.1186/s12913-019-3911-x.
PubMed 30683083Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
PubMed 36161615Ohgoshi Y, Ando A, Kawamata N, Kubo EN. Continuous modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) for major abdominal surgery. J Clin Anesth. 2020 Mar;60:45-46. doi: 10.1016/j.jclinane.2019.08.031. Epub 2019 Aug 20. No abstract available.
PubMed 31442859Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.
PubMed 30639940
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Modified Perichondral Approach Thoracoabdominal Nerve Block For Post Cesarean Section Pain
- ClinicalTrials.gov ID
- NCT06078475
- Acronym / sponsor ID
- Bursa City Hospital 3
- Conditions
- Cesarean Section
- Keywords
- Cesarean Section Pain, Postoperative Analgesia, Modified Perichondral Approach Thoracoabdominal Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 11 Oct 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.
Cesarean section (CS) is one of the most frequently performed surgical procedures in the World. Moderate to severe postoperative pain occurs in a significant proportion of women after cesarean surgery.
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a novel technique that provides effective analgesia in the anterior and lateral thoracoabdominal areas, where local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral Wall, provides analgesia in the abdominal area at the T5-T11 level.
The aim of this study is to evaluate the effectiveness of US-guided M-TAPA block for postoperative analgesia management after cesarean section.
Detailed description
Cesarean section (CS) is one of the most frequently performed surgical procedures in the World, in European countries, approximately 20% of deliveries are CS. Moderate to severe postoperative pain occurs in a significant proportion of women after cesarean surgery. This delays recovery and returning to daily life. Postoperative pain disrupts the mother-child bond, makes breastfeeding difficult, and affects the psychological state of the mother. Also inadequate postoperative analgesia may cause hyperalgesia and chronic pain.
Perioperative pain should be managed with a multi-modal approach. Opioids and nonsteroid anti inflammatory drugs should be considered as components of a multimodal analgesic regimen. However, use of both systemic and neuraxial opioids may be associated with effects (respiratory depression, nausea, vomiting, sedation, pruritus, hyperalgesia). For this, interfacial blocks may be preffered to provide postoperative analgesia and reduced opioid consumption.
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a novel technique that provides effective analgesia in the anterior and lateral thoracoabdominal areas, where local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral Wall, provides analgesia in the abdominal area at the T5-T11 level. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen under US guidance.
In the literature, there are studies investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery. However, there is no randomized study evaluating the effectiveness of M-TAPA block for postoperative analgesia management after CS. The aim of this study is to evaluate the effectiveness of US-guided M-TAPA block for postoperative analgesia management after cesarean section. The primary outcome is to compare global recovery scores, the secondary outcome is to compare postoperative pain scores (NRS), to evaluate postoperative rescue analgesic (opioid) use and side effects (allergic reaction, nausea, vomiting) associated with opioid use in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two models for this study. Modified Perichondral Approach Thoracoabdominal Nerve block (M-TAPA block) group, and Control (C) group
| Arm | Type | Receives |
|---|---|---|
| Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group) | Active comparator | Other: Postoperative analgesia managementIn group M-TAPA, M-TAPA block will be performed with patient is in the supine position. After providing aseptic conditions, the high frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed in the sagittal plane where the midclavicular line intersects with the costal cartilage corresponding to the costochondral angle. Using the In Plane technique, the probe is gently pushed to visualize the lower part of the costochondral angle at the central level, advancing the block needle in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage, and the block location will be confirmed. After the block location is confirmed, a total of 20 ml + 20 ml of 0.25% bupivacaine(Buvasin %5 flakon) (total 40 ml for both sides) will be injected bilaterally. |
| Group C (Control group) | Active comparator | Other: Postoperative analgesia managementIn the control group, analgesics will be administered according to the protocol in postoperative analgesia management. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification II
- Elective cesarean section, and gestational age above 37 weeks will be included
Key exclusion criteria (5 listed)
- Bleeding diathesis
- Anticoagulant treatment
- Local anesthetics and opioid allergy
- Infection at the site of block
- Patients who do not accept the procedure
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 managementPatients will be administered paracetamol 1 gr (PERFALGAN® ) IV every 8 hours in the postoperative period.. If the patient's NRS score is ≥ 4 0,5 mg/kg IV meperidine (Aldolan ampul 100 mg/2 ml) will be administered. | Other | Group C (Control group), Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group) |
Primary outcome
Global recovery scoring system (patient satisfaction scale)
Time frame: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
We will use the Turkish version of Quality of Recovery / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed
2 secondary outcomes
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Time frame: Patients will be evaluated at the first 24 hours period postoperatively.
The use of rescue analgesia
Time frame: Meperidine consumption will be recorded at the first 24 hours period postoperatively. (Number of Participants and Concentration of Meperidin)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- 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 30683083Kintu A, Abdulla S, Lubikire A, Nabukenya MT, Igaga E, Bulamba F, Semakula D, Olufolabi AJ. Postoperative pain after cesarean section: assessment and management in a tertiary hospital in a low-income country. BMC Health Serv Res. 2019 Jan 25;19(1):68. doi: 10.1186/s12913-019-3911-x.
- Background: PubMed 36161615Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
- Background: PubMed 31442859Ohgoshi Y, Ando A, Kawamata N, Kubo EN. Continuous modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) for major abdominal surgery. J Clin Anesth. 2020 Mar;60:45-46. doi: 10.1016/j.jclinane.2019.08.031. Epub 2019 Aug 20. No abstract available.
- Background: PubMed 30639940Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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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.
T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi
Bursa, Turkey (Türkiye)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative analgesia management in people with Cesarean Section, run by Bursa City Hospital at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global recovery scoring system (patient satisfaction scale) (time frame: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 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 NCT06078475, which also lists 5 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 23 Apr 2024.