Pain, PostoperativeNCT06566859
Comparison of ESP Block and M-TAPA Block Efficiency in Postoperative Analgesia Management in Nephrectomy Cases
An observational study of Pain, Postoperative, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Relieving postoperative nephrectomy pain requires multimodal approaches. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- NRS 0. hour, NRS 6. Hour and NRS 12. Hour
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Feb 2025
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy. .
Who may be able to join
- All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy
Who cannot join
- ASA ≥3
- Body mass index>35 kg/ m²
- Infection in the block area
- Coagulation disorder,
- Known allergy to local anesthetics
- Pregnant
Show all 10Show fewer
- Patient with neuropathy
- Patient without cooperation
- Patient who refuses to participate in the study
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Relieving postoperative nephrectomy pain requires multimodal approaches. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.
Read the detailed description
Relieving postoperative nephrectomy pain requires multimodal approaches. The most commonly used in the treatment of pain are nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and infiltration of local anesthetics. Due to the side effects of NSAIDs and opioids, the application of regional analgesia techniques can reduce complications while providing better analgesia quality. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. Pain is considered one of the most important factors affecting the quality of healing. Postoperative pain delays the postanesthesia care unit, hospital stay, early ambulation, increases resource utilization, and negatively affects patient satisfaction. If postoperative analgesia is provided, all these negativities will be eliminated. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.
- Conditions
- Pain, Postoperative
- Being tested
- NRS 0. hour, NRS 6. Hour, NRS 12. Hour, NRS 24. Hour
- Keywords
- nerve block, pain management, postoperative period, postoperative complications, regional anesthesia, pain
- Medical subject headings
- Pain, Postoperative, Agnosia, Postoperative Complications, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRS 0. hourOther
Numerical rating scala
NRS 6. HourOther
Numerical rating scala
NRS 12. HourOther
Numerical rating scala
NRS 24. HourOther
Numerical rating scala
| Study group | Role | What they receive |
|---|---|---|
| M-TAPA Block | Patients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and M-TAPA block is applied under ultrasound guidance in the preoperative period. For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc. Receives: Other: NRS 0. hour; Other: NRS 6. Hour; Other: NRS 12. Hour; Other: NRS 24. Hour | |
| ESP Block | Patients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and ESP block is applied under ultrasound guidance in the preoperative period. For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc. Receives: Other: NRS 0. hour; Other: NRS 6. Hour; Other: NRS 12. Hour; Other: NRS 24. Hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Management
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
Measured: 0.hour
Postoperative Pain Management
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
Measured: 6.hour
Postoperative Pain Management
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
Measured: 12.hour
Postoperative Pain Management
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
Measured: 24.hour
Postoperative Pain Management
Total amount of analgesic used in 24 hours
Measured: 24 hours
Postoperative Pain Management
Time of first additional analgesic requirement up to 24 hours
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 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilal AKCA, Başakşehir Çam & Sakura City Hospital
- Investigators
- Hilal Akça, Principal investigator, BasaksehirCamSakuraH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566859
- Sponsor's protocol ID
- 2024-297
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ESP Block and M-TAPA Block Efficiency in Postoperative Analgesia Management in Nephrectomy Cases
- ClinicalTrials.gov ID
- NCT06566859
- Acronym / sponsor ID
- 2024-297
- Conditions
- Pain, Postoperative
- Keywords
- nerve block, pain management, postoperative period, postoperative complications, regional anesthesia, pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 22 Aug 2024 (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.
Relieving postoperative nephrectomy pain requires multimodal approaches. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.
Detailed description
Relieving postoperative nephrectomy pain requires multimodal approaches. The most commonly used in the treatment of pain are nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and infiltration of local anesthetics. Due to the side effects of NSAIDs and opioids, the application of regional analgesia techniques can reduce complications while providing better analgesia quality. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. Pain is considered one of the most important factors affecting the quality of healing. Postoperative pain delays the postanesthesia care unit, hospital stay, early ambulation, increases resource utilization, and negatively affects patient satisfaction. If postoperative analgesia is provided, all these negativities will be eliminated. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-TAPA Block | – | Other: NRS 0. hour, Other: NRS 6. Hour, Other: NRS 12. Hour, Other: NRS 24. HourPatients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and M-TAPA block is applied under ultrasound guidance in the preoperative period. For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc. |
| ESP Block | – | Other: NRS 0. hour, Other: NRS 6. Hour, Other: NRS 12. Hour, Other: NRS 24. HourPatients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and ESP block is applied under ultrasound guidance in the preoperative period. For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy. .
Key inclusion criteria (1 listed)
- All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy
Key exclusion criteria (10 listed)
- ASA ≥3
- Body mass index>35 kg/ m²
- Infection in the block area
- Coagulation disorder,
- Known allergy to local anesthetics
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 |
|---|---|---|
| NRS 0. hourNumerical rating scala | Other | ESP Block, M-TAPA Block |
| NRS 6. HourNumerical rating scala | Other | ESP Block, M-TAPA Block |
| NRS 12. HourNumerical rating scala | Other | ESP Block, M-TAPA Block |
| NRS 24. HourNumerical rating scala | Other | ESP Block, M-TAPA Block |
Primary outcome
Postoperative Pain Management
Time frame: 0.hour
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
Postoperative Pain Management
Time frame: 6.hour
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
Postoperative Pain Management
Time frame: 12.hour
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
Postoperative Pain Management
Time frame: 24.hour
The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.
Postoperative Pain Management
Time frame: 24 hours
Total amount of analgesic used in 24 hours
Postoperative Pain Management
Time frame: 24 hours
Time of first additional analgesic requirement up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
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 recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Hilal Akça principal investigator
BasaksehirCamSakuraH
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 Pain, Postoperative, run by Başakşehir Çam & Sakura City Hospital 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 10 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 22 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilal Akça (05548421509, drhllbs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Management (time frame: 0.hour). The study lists 6 primary outcomes in all. 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 Aug 2024.