Clinical trial NCT06540586: Postoperative Analgesic Efficacy of Modified TAPA and QL Blocks in Laparoscopic Cholecystectomies
Official title: Evaluation of the Postoperative Analgesic Efficacy of Modified Thoracoabdominal Plane Block With Perichondral Approach and Quadratus Lumborum Block in Laparoscopic Cholecystectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain Management
Postoperative Pain
Analgesia
Nerve Blocks
Cholecystectomy
Keywords: postoperative pain
laparoscopic cholecystectomy
quadratus lumborum block
m-tapa block
abdominal wall blocks
postoperative analgesia
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of Postoperative Analgesic Effects of M-TAPA and Anterior Quadratus Lumborum Blocks in Laparoscopic Cholecystectomies.

Detailed description: In trunk blocks, the interfascial area between the anterior abdominal wall or back muscles is targeted. Local anesthetics are used for this purpose. Since there is no blood circulation and vascularization in the interfascial areas, the absorption of local anesthetics is slow, providing long-lasting analgesia. Therefore, they are used as a part of multimodal analgesia. The effectiveness of trunk blocks can vary depending on the patient's anatomical differences and previous surgeries, but on average, analgesic effectiveness lasts for 8-12 hours. Sometimes analgesic effectiveness extending up to 24 hours has been reported.

In laparoscopic cholecystectomy operations, pain plays a role in postoperative atelectasis, pneumonia due to atelectasis, prolonged hospital stay, and discharge. To reduce the use of opioids due to their side effects such as nausea, vomiting, itching, constipation, and addiction, opioid-free analgesia is applied, and regional techniques are used. Quadratus lumborum blocks and M-TAPA blocks have been safely and easily applied in abdominal surgery in recent years thanks to developments in trunk blocks and ultrasound technology, and they are frequently preferred.

Eligibility criteria: Inclusion Criteria: American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

* Inclusion Criteria:
* 18-65 years of age
* American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

* local anesthetic allergy
* Infection at the procedure site Body Mass Index \>35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders Contraindications to regional anesthesia several lung and heart disease

Primary outcomes:
measure: Total amount of opioid requirements
timeFrame: within 24 hours after the surgery
Secondary outcomes:
measure: rescue analgesia
timeFrame: within 24 hours after the surgery
Other outcomes:
measure: intraoperative remifentanil consumption
timeFrame: during operation procedure]
measure: Visual Analogue Scale values
timeFrame: at 1st, 4th,8th 12th and 24th hours after the surgery]
measure: side effects such as nausea, vomiting and shoulder pain
timeFrame: within 24 hours after the surgery
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Research and Education Hospital
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: serpil sehirlioglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziosmanpasa Research and Education Hospital
name: turan aydemir, MD
role: STUDY_DIRECTOR
affiliation: Gaziosmanpasa Research and Education Hospital
name: döndü moralar, MD
role: STUDY_DIRECTOR
References:
citation: Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
citation: Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.
citation: 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.