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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.
A. Treatment of patients in P1 and P2 before entering the operating room:
B. Treatment of patients in the operating room P1 and P2:
Group P1:
Group P2 No block is performed, after the operation is completed, extubation preparation is carried out immediately.
Procedures P1 and P2 after surgery:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
|
| Opioid Intravena | Active Comparator | This Group receive opioid intravena post surgery without M-TAPA Block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA | Procedure | USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| QoR 40 | Collect completed questionnaires QoR40 by participant. The score range from 40(Extremely poor quality) to 200 (excellent quality) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia Christiana, MD | Contact | +6282398565260 | ameliachristiana@student.unud.ac.id | |
| Ita Indriani, MD | Contact | +6281284847887 | indriani.ita@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| WHO WHO | World Health Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof I.G.N.G Ngoerah General Hospital | Recruiting | Denpasar | Bali | 80113 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30498388 | Background | 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. | |
| 39217281 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2024 | Oct 19, 2024 |
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Double Blind
|
| Opioid Intravena | Device | Opioid Intravenous post Surgery without M-TAPA Block delivered with PCA Machine |
|
|
| 24 hours |
| 30122981 | Background | 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. |
| 27366460 | Background | 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. |
| 38074287 | Background | 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. |
| 36575362 | Background | 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. |
| 30639940 | Background | 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. |
| 36307755 | Result | 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. |
| 38655995 | Result | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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