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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA and Opioid Intravena
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
  • Prof I.G.N.G Ngoerah General Hospital

    Denpasar, Bali, 80113

    Prof Ngoerah General Hospital, 0361 227912, info@profngoerahhospital.com

    Amelia Christiana, MD

    Recruiting

Other trials in Indonesia

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
  1. Treatment of patients in P1 and P2 before entering the operating room:
  2. 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.
  3. 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
  4. Treatment of patients in the operating room P1 and P2:
  5. General anesthesia was performed in both groups.
  6. General anesthesia begins with preoxygenation for 3-5 minutes with 100% O2.
  7. Continued induction using intravenous propofol 2 mg/kgBW and intravenous fentanyl 2 mcg/kgBW.
  8. After the patient is induced, continue by giving the muscle relaxant atracurium 0.5 mg/kgBW intravenously.
  9. After three minutes, laryngoscopy and intubation are performed using an endotracheal tube (ETT) with a size according to the patient needs.
  10. Maintain anesthesia with oxygen and compressed air with a ratio of 1 liter: 1 liter and sevoflurane.
  11. 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.
  12. 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:

  1. Continue with preparation for the block procedure on the patient.
  2. 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.
  3. Then the area of action is disinfected, with the sequence of 70% alcohol, betadine, 70% alcohol then a sterile hole drape is installed.
  4. 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.
  5. 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.
  6. 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.
  7. After the needle injection is removed, a block is performed with the same procedure on the opposite side.
  8. Evaluation of the success of the M-TAPA block is carried out and monitor the occurrence of blood vessel puncture, hypotension, desaturation, and bradycardia.
  9. 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.
  10. If bradycardia occurs with unstable hemodynamics, the patient is given an intravenous injection of atropine sulfate 0.5 mg.
  11. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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 groups in NCT06652581
Study groupRoleWhat they receive
Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA)ExperimentalUSG 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 IntravenaActive comparatorThis 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted22 Oct 2024
  2. Study start12 Sep 2024
  3. Primary completion12 Nov 2024 (estimated)
  4. Study completion13 Nov 2024 (estimated)

Resources

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)
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 30498388
  • Castillo-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 39217281
  • El-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 30122981
  • Erbabacan 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 27366460
  • Fakhoury 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 38074287
  • Gungor 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 36575362
  • Tulgar 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
  • Bilge 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 36307755
  • Erten 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

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.

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