Laparoscopic CholecystectomyNCT06652581
Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) In Laparoscopic Cholecystectomy
A study testing Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA and Opioid Intravena in people with Laparoscopic Cholecystectomy and Peripheral Nerve Block, run by Udayana University at 1 site in Indonesia.
Trial summary
The Goal of this clinical trial is to determine the advantages of using Peripheral Nerve Block by injecting drugs under the skin on both sides of the abdomen in the upper abdominal area in patients undergoing laparoscopic Cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy, Peripheral Nerve Block
- What is being tested?
- Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA and Opioid Intravena
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Sep 2024to 13 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient 18-65 yeasr old
- IMT 17.5-30 kg/m2
- Patient with ASA I-II
Who cannot join
- Patient Refusal
- Local Infection
- Chronic Analgesia drug user
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Prof I.G.N.G Ngoerah General Hospital
Denpasar, Bali, 80113
Prof Ngoerah General Hospital, 0361 227912, info@profngoerahhospital.com
Amelia Christiana, MD
About this study
Official title: Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) Post-Operative Analgesia Compared To Intravenous Opioids In Laparoscopic Cholecystectomy Patients
The Goal of this clinical trial is to determine the advantages of using Peripheral Nerve Block by injecting drugs under the skin on both sides of the abdomen in the upper abdominal area in patients undergoing laparoscopic Cholecystectomy. Study participants will be divided into 2 groups, namely group P1 receiving Modified Thoracoabdominal Perichondrial Approach (M-TAPA) block anesthesia after laparoscopic cholecystectomy and group P2 only receiving intravenous opioids postoperatively. Peripheral nerve blocks on both sides of the upper abdomen are expected to be able to prolong the duration of pain relief, reduce the pain scale, and the total dose of pain medication needed postoperatively. The injection of this peripheral nerve block drug will be carried out by an anesthesiologist. Researchers will continue to anticipate the occurrence of side effects that can occur with strict monitoring and emergency care standards. This study will last up to 24 hours after surgery.
The main question it aims to answer is:
To prove that the amount of postoperative intravenous opioid consumption with M-TAPA block is lower than the control group.
Read the detailed description
- Treatment of patients in P1 and P2 before entering the operating room:
- Every patient who meets the eligibility criteria will be asked for consent to become a subject of this study. Proof of consent is the signing of a letter of willingness to become a subject of the study by the informant, the consent giver, and one witness. Quality of Recovery using QoR 40 form will evaluate before surgery and 24 hours after surgery.
- Patients have been fasted for 8 hours from solid food before surgery, clear water up to 2 hours before surgery. The infusion is installed 2 hours before the patient is sent to the operating room using an 18G intravenous catheter with Ringer lactate fluid at a rate of administration according to the patient weight 10 ml/kg/hour
- Treatment of patients in the operating room P1 and P2:
- General anesthesia was performed in both groups.
- General anesthesia begins with preoxygenation for 3-5 minutes with 100% O2.
- Continued induction using intravenous propofol 2 mg/kgBW and intravenous fentanyl 2 mcg/kgBW.
- After the patient is induced, continue by giving the muscle relaxant atracurium 0.5 mg/kgBW intravenously.
- After three minutes, laryngoscopy and intubation are performed using an endotracheal tube (ETT) with a size according to the patient needs.
- Maintain anesthesia with oxygen and compressed air with a ratio of 1 liter: 1 liter and sevoflurane.
- All patients were performed with the same laparoscopic cholecystectomy procedure (4-port technique), umbilical port (5mm), infraxiphoidal (15-20 mm), lateral intersection of the umbilicus and axillary line (5 mm), and symmetrical assistant port (5 mm). With a pneumoperitoneum pressure of 10-12 mmHg.
- Continue with the operation until completion. One hour before the surgery is completed, the patient is given anti-vomiting prophylaxis ondansetron 0.1 mg/kgBW intravenously.
Group P1:
- Continue with preparation for the block procedure on the patient.
- After the necessary tools and materials are ready, the Anesthesiologist who will perform the block washes his hands sterilely, uses a sterile gown and gloves.
- Then the area of action is disinfected, with the sequence of 70% alcohol, betadine, 70% alcohol then a sterile hole drape is installed.
- Identification of the place to perform the block is carried out, namely between the midclavicular line and the anterior axillary. The injection identification guide uses ultrasound.
- The ultrasound machine uses a linear probe placed on the chondrium with a sagittal cut at Costa 10, identifying the external oblique muscle, internal oblique, transversus abdominis, costal cartilage. Stimuplex 22Gx50mm is injected using the in-plane technique. The tip of the needle is placed under the chondrium.
- Before injecting local anesthetic drugs, negative aspiration (exclusion of intravascular injection) and hydrodissection using 0.9% NaCl as much as 1 - 2 ml are performed to further ensure the area of the needle tip. Local anesthetic bupivacaine 0.25% as much as 20 ml is then injected into the field.
- After the needle injection is removed, a block is performed with the same procedure on the opposite side.
- Evaluation of the success of the M-TAPA block is carried out and monitor the occurrence of blood vessel puncture, hypotension, desaturation, and bradycardia.
- If hypotension occurs, if the pulse rate is ≥ 60 x / minute, bolus phenylephrine 50 mcg, if the pulse rate is > 60 x / minute, bolus ephedrine 4 mg IV until the mean arterial pressure (MAP) returns to the baseline value. If there is no improvement, it can be repeated at 5-minute intervals. If hypotension persists, norepinephrine is given by titration at a dose of 0.1 mcg / kgBW / minute.
- If bradycardia occurs with unstable hemodynamics, the patient is given an intravenous injection of atropine sulfate 0.5 mg.
- If desaturation occurs, perform a physical examination for signs of pneumothorax (lung sounds disappear, hyperresonant percussion), if tension pneumothorax occurs, perform needle decompression then consult a colleague in cardiovascular thoracic surgery (BTKV) for further management.
Group P2 No block is performed, after the operation is completed, extubation preparation is carried out immediately.
Procedures P1 and P2 after surgery:
- After the block is completed, the patient is given an injection of neostigmine and atropine sulfate to antagonize the remaining atracurium drug still in the patient's body. The patient is extubated after the patient's breathing is adequate and the airway is clear.
- The patient is observed in the recovery room for 2 hours and transferred to the room if there are no complaints and the Aldrete score is ;9. The pain scale using Numeric Rating Scale is evaluated for the first 0 hours in the recovery room. Observations in the recovery room include: patient complaints, blood pressure, pulse, ECG, respiratory rate and peripheral saturation are carried out every 15 minutes until the patient is transferred to the room. The observation results are recorded on the patient's anesthesia record sheet.
- After the patient moves to the room, the acute pain service (APS) team will evaluate the pain scale with Numeric Rating Scale (NRS) at 2, 12, 24 hours postoperatively and the total opioid consumption data on the PCA machine will be recorded.
- Quality of Recovery will evaluate again 24 hours Post Operative.
- Being tested
- Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA, Opioid Intravena
- Keywords
- Analgesia, Laparoscopy Cholecystectomy, Peripheral Nerve Block, Pain management, Ultrasound, Postoperative Pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPAProcedure or surgery
Also called P1
USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%.
Opioid IntravenaDevice
Also called P2
Opioid Intravenous post Surgery without M-TAPA Block delivered with PCA Machine
| Study group | Role | What they receive |
|---|---|---|
| Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA) | Experimental | USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%. Receives: Procedure: Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA |
| Opioid Intravena | Active comparator | This Group receive opioid intravena post surgery without M-TAPA Block Receives: Device: Opioid Intravena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proving the effectiveness of postoperative analgesia with Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) in laparoscopic cholecystectomy patients at Prof. I.G.N.G. Ngoerah General Hospital.
Evaluate total PCA Intravena opioid consumption (morphin in mg) delivered dose.
Measured: 24 hours
Secondary outcomes (2)
Numeric rating Scale
Evaluate Pain Scale using Numeric Rating Scale (NRS) rest and movement 0,2, 12, 24 hours for operative. Range 0-10, 0 is no pain, 10 is severe pain
Measured: 24 hours
QoR 40
Collect completed questionnaires QoR40 by participant. The score range from 40(Extremely poor quality) to 200 (excellent quality)
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 Oct 2024
- Study start12 Sep 2024
- Primary completion12 Nov 2024 (estimated)
- Study completion13 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amelia christiana, Udayana University
- Investigators
- WHO WHO, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652581
- Sponsor's protocol ID
- 2176/UN14.2.2.VII.14/LT/2024
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blythe J, Herrmann E, Faust D, Falk S, Edwards-Lehr T, Stockhausen F, Hanisch E, Buia A. Acute cholecystitis - a cohort study in a real-world clinical setting (REWO study, NCT02796443). Pragmat Obs Res. 2018 Oct 25;9:69-75. doi: 10.2147/POR.S169255. eCollection 2018.
PubMed 30498388Castillo-Davila LF, Torres-Anaya CJ, Vazquez-Apodaca R, Borboa-Olivares H, Espino-Y-Sosa S, Torres-Torres J. Modified thoracoabdominal nerve block via perichondral approach: an alternative for perioperative pain management in laparoscopic cholecystectomy in a middle-income country. BMC Anesthesiol. 2024 Aug 31;24(1):304. doi: 10.1186/s12871-024-02690-8.
PubMed 39217281El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018 Aug 8;11:35-44. doi: 10.2147/LRA.S154512. eCollection 2018.
PubMed 30122981Erbabacan E, Kendigelen P, Koksal GM, Tutuncu C, Ekici BB, Seker TB, Kaya G, Altindas F. Comparison of Transversus Abdominis Plane Block and IV Patient-Controlled Analgesia after Lower Abdominal Surgery. Turk J Anaesthesiol Reanim. 2015 Feb;43(1):24-8. doi: 10.5152/TJAR.2014.82788. Epub 2014 Dec 9.
PubMed 27366460Fakhoury HMA, Yousef Z, Tamim H, Daher S, Attasi AA, Al Ajlan A, Hajeer AH. Combined effect of age and body mass index on postoperative mortality and morbidity in laparoscopic cholecystectomy patients. Front Surg. 2023 Nov 23;10:1243915. doi: 10.3389/fsurg.2023.1243915. eCollection 2023.
PubMed 38074287Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.
PubMed 36575362Tulgar 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 30639940Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.
PubMed 36307755Erten E, Kara U, Simsek F, Oztas M, Suzer MA, Kamburoglu H, Eskin MB, Senkal S, Cosar A. Modified thoracoabdominal nerves block through perichondrial approach for laparoscopic cholecystectomy. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20230962. doi: 10.1590/1806-9282.20230962. eCollection 2024.
PubMed 38655995
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) Post-Operative Analgesia Compared To Intravenous Opioids In Laparoscopic Cholecystectomy Patients
- ClinicalTrials.gov ID
- NCT06652581
- Acronym / sponsor ID
- 2176/UN14.2.2.VII.14/LT/2024
- Keywords
- Analgesia, Laparoscopy Cholecystectomy, Peripheral Nerve Block, Pain management, Ultrasound, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 12 Nov 2024 (estimated)
- Study completion
- 13 Nov 2024 (estimated)
- First posted
- 22 Oct 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.
The Goal of this clinical trial is to determine the advantages of using Peripheral Nerve Block by injecting drugs under the skin on both sides of the abdomen in the upper abdominal area in patients undergoing laparoscopic Cholecystectomy. Study participants will be divided into 2 groups, namely group P1 receiving Modified Thoracoabdominal Perichondrial Approach (M-TAPA) block anesthesia after laparoscopic cholecystectomy and group P2 only receiving intravenous opioids postoperatively. Peripheral nerve blocks on both sides of the upper abdomen are expected to be able to prolong the duration of pain relief, reduce the pain scale, and the total dose of pain medication needed postoperatively. The injection of this peripheral nerve block drug will be carried out by an anesthesiologist. Researchers will continue to anticipate the occurrence of side effects that can occur with strict monitoring and emergency care standards. This study will last up to 24 hours after surgery.
The main question it aims to answer is:
To prove that the amount of postoperative intravenous opioid consumption with M-TAPA block is lower than the control group.
Detailed description
- Treatment of patients in P1 and P2 before entering the operating room:
- Every patient who meets the eligibility criteria will be asked for consent to become a subject of this study. Proof of consent is the signing of a letter of willingness to become a subject of the study by the informant, the consent giver, and one witness. Quality of Recovery using QoR 40 form will evaluate before surgery and 24 hours after surgery.
- Patients have been fasted for 8 hours from solid food before surgery, clear water up to 2 hours before surgery. The infusion is installed 2 hours before the patient is sent to the operating room using an 18G intravenous catheter with Ringer lactate fluid at a rate of administration according to the patient weight 10 ml/kg/hour
- Treatment of patients in the operating room P1 and P2:
- General anesthesia was performed in both groups.
- General anesthesia begins with preoxygenation for 3-5 minutes with 100% O2.
- Continued induction using intravenous propofol 2 mg/kgBW and intravenous fentanyl 2 mcg/kgBW.
- After the patient is induced, continue by giving the muscle relaxant atracurium 0.5 mg/kgBW intravenously.
- After three minutes, laryngoscopy and intubation are performed using an endotracheal tube (ETT) with a size according to the patient needs.
- Maintain anesthesia with oxygen and compressed air with a ratio of 1 liter: 1 liter and sevoflurane.
- All patients were performed with the same laparoscopic cholecystectomy procedure (4-port technique), umbilical port (5mm), infraxiphoidal (15-20 mm), lateral intersection of the umbilicus and axillary line (5 mm), and symmetrical assistant port (5 mm). With a pneumoperitoneum pressure of 10-12 mmHg.
- Continue with the operation until completion. One hour before the surgery is completed, the patient is given anti-vomiting prophylaxis ondansetron 0.1 mg/kgBW intravenously.
Group P1:
- Continue with preparation for the block procedure on the patient.
- After the necessary tools and materials are ready, the Anesthesiologist who will perform the block washes his hands sterilely, uses a sterile gown and gloves.
- Then the area of action is disinfected, with the sequence of 70% alcohol, betadine, 70% alcohol then a sterile hole drape is installed.
- Identification of the place to perform the block is carried out, namely between the midclavicular line and the anterior axillary. The injection identification guide uses ultrasound.
- The ultrasound machine uses a linear probe placed on the chondrium with a sagittal cut at Costa 10, identifying the external oblique muscle, internal oblique, transversus abdominis, costal cartilage. Stimuplex 22Gx50mm is injected using the in-plane technique. The tip of the needle is placed under the chondrium.
- Before injecting local anesthetic drugs, negative aspiration (exclusion of intravascular injection) and hydrodissection using 0.9% NaCl as much as 1 - 2 ml are performed to further ensure the area of the needle tip. Local anesthetic bupivacaine 0.25% as much as 20 ml is then injected into the field.
- After the needle injection is removed, a block is performed with the same procedure on the opposite side.
- Evaluation of the success of the M-TAPA block is carried out and monitor the occurrence of blood vessel puncture, hypotension, desaturation, and bradycardia.
- If hypotension occurs, if the pulse rate is ≥ 60 x / minute, bolus phenylephrine 50 mcg, if the pulse rate is > 60 x / minute, bolus ephedrine 4 mg IV until the mean arterial pressure (MAP) returns to the baseline value. If there is no improvement, it can be repeated at 5-minute intervals. If hypotension persists, norepinephrine is given by titration at a dose of 0.1 mcg / kgBW / minute.
- If bradycardia occurs with unstable hemodynamics, the patient is given an intravenous injection of atropine sulfate 0.5 mg.
- If desaturation occurs, perform a physical examination for signs of pneumothorax (lung sounds disappear, hyperresonant percussion), if tension pneumothorax occurs, perform needle decompression then consult a colleague in cardiovascular thoracic surgery (BTKV) for further management.
Group P2 No block is performed, after the operation is completed, extubation preparation is carried out immediately.
Procedures P1 and P2 after surgery:
- After the block is completed, the patient is given an injection of neostigmine and atropine sulfate to antagonize the remaining atracurium drug still in the patient's body. The patient is extubated after the patient's breathing is adequate and the airway is clear.
- The patient is observed in the recovery room for 2 hours and transferred to the room if there are no complaints and the Aldrete score is ;9. The pain scale using Numeric Rating Scale is evaluated for the first 0 hours in the recovery room. Observations in the recovery room include: patient complaints, blood pressure, pulse, ECG, respiratory rate and peripheral saturation are carried out every 15 minutes until the patient is transferred to the room. The observation results are recorded on the patient's anesthesia record sheet.
- After the patient moves to the room, the acute pain service (APS) team will evaluate the pain scale with Numeric Rating Scale (NRS) at 2, 12, 24 hours postoperatively and the total opioid consumption data on the PCA machine will be recorded.
- Quality of Recovery will evaluate again 24 hours Post Operative.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA) | Experimental | Procedure: Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPAUSG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%. |
| Opioid Intravena | Active comparator | Device: Opioid IntravenaThis Group receive opioid intravena post surgery without M-TAPA Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient 18-65 yeasr old
- IMT 17.5-30 kg/m2
- Patient with ASA I-II
Key exclusion criteria (3 listed)
- Patient Refusal
- Local Infection
- Chronic Analgesia drug user
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 |
|---|---|---|
| Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPAAlso: P1USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%. | Procedure or surgery | Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA) |
| Opioid IntravenaAlso: P2Opioid Intravenous post Surgery without M-TAPA Block delivered with PCA Machine | Device | Opioid Intravena |
Primary outcome
Proving the effectiveness of postoperative analgesia with Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) in laparoscopic cholecystectomy patients at Prof. I.G.N.G. Ngoerah General Hospital.
Time frame: 24 hours
Evaluate total PCA Intravena opioid consumption (morphin in mg) delivered dose.
2 secondary outcomes
Numeric rating Scale
Time frame: 24 hours
QoR 40
Time frame: 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 Oct 2024.
- Background: PubMed 30498388Blythe J, Herrmann E, Faust D, Falk S, Edwards-Lehr T, Stockhausen F, Hanisch E, Buia A. Acute cholecystitis - a cohort study in a real-world clinical setting (REWO study, NCT02796443). Pragmat Obs Res. 2018 Oct 25;9:69-75. doi: 10.2147/POR.S169255. eCollection 2018.
- Background: PubMed 39217281Castillo-Davila LF, Torres-Anaya CJ, Vazquez-Apodaca R, Borboa-Olivares H, Espino-Y-Sosa S, Torres-Torres J. Modified thoracoabdominal nerve block via perichondral approach: an alternative for perioperative pain management in laparoscopic cholecystectomy in a middle-income country. BMC Anesthesiol. 2024 Aug 31;24(1):304. doi: 10.1186/s12871-024-02690-8.
- Background: PubMed 30122981El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018 Aug 8;11:35-44. doi: 10.2147/LRA.S154512. eCollection 2018.
- Background: PubMed 27366460Erbabacan E, Kendigelen P, Koksal GM, Tutuncu C, Ekici BB, Seker TB, Kaya G, Altindas F. Comparison of Transversus Abdominis Plane Block and IV Patient-Controlled Analgesia after Lower Abdominal Surgery. Turk J Anaesthesiol Reanim. 2015 Feb;43(1):24-8. doi: 10.5152/TJAR.2014.82788. Epub 2014 Dec 9.
- Background: PubMed 38074287Fakhoury HMA, Yousef Z, Tamim H, Daher S, Attasi AA, Al Ajlan A, Hajeer AH. Combined effect of age and body mass index on postoperative mortality and morbidity in laparoscopic cholecystectomy patients. Front Surg. 2023 Nov 23;10:1243915. doi: 10.3389/fsurg.2023.1243915. eCollection 2023.
- Background: PubMed 36575362Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.
- 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.
- Results publication: PubMed 36307755Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.
- Results publication: PubMed 38655995Erten E, Kara U, Simsek F, Oztas M, Suzer MA, Kamburoglu H, Eskin MB, Senkal S, Cosar A. Modified thoracoabdominal nerves block through perichondrial approach for laparoscopic cholecystectomy. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20230962. doi: 10.1590/1806-9282.20230962. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
WHO WHO principal investigator
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA and Opioid Intravena in people with Laparoscopic Cholecystectomy and Peripheral Nerve Block, run by Udayana University at 1 site in Indonesia.
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 3 inclusion and 3 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 Oct 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 Indonesia. 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 Amelia Christiana, MD (+6282398565260, ameliachristiana@student.unud.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proving the effectiveness of postoperative analgesia with Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) in laparoscopic cholecystectomy patients at Prof. I.G.N.G. Ngoerah General Hospital. (time frame: 24 hours). 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 NCT06652581, which also lists 9 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 22 Oct 2024.