- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06540586
Postoperative Analgesic Efficacy of Modified TAPA and QL Blocks in Laparoscopic Cholecystectomies
Evaluation of the Postoperative Analgesic Efficacy of Modified Thoracoabdominal Plane Block With Perichondral Approach and Quadratus Lumborum Block in Laparoscopic Cholecystectomies
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey, 34000
- Gaziosmanpasa Research and Education Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- Inclusion Criteria:
- scheduled for elective Laparoscopic chplecystectomy
- Patients aged ≥18 years
- American Society of Anesthesiologists physical status (ASA) Ⅰ-II
Exclusion Criteria:
ASA III-IV patient
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Quadratus lumborum block group
Patients are placed in the lateral decubitus position.
The area where the block will be applied is disinfected with povidine iodine.
A convex ultrasound probe is placed on the midaxillary line above the iliac crest.
By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected.
The same is done to the opposite side.
|
Patients are placed in the lateral decubitus position.
The area where the block will be applied is disinfected with povidine iodine.
A convex ultrasound probe is placed on the midaxillary line above the iliac crest.
By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected.
The same is done to the opposite side.
|
|
Active Comparator: m-tapa block
In the M-TAPA block group, with the patient in the supine position, a linear high-frequency linear ultrasound (USG) probe is angled to visualize the inferior surface of the costochondral junction at the level of the 10th costochondral cartilage.
Under sterile conditions, using the in-plane technique with a 22G 80 mm peripheral block needle, the needle is advanced posterior to the 10th costal cartilage by taking the lower edge of the cartilage in the sagittal plane as the midline.
After hydrodissection with 2-3 ml isotonic saline to confirm the site, 20 ml of 0.25% Bupivacaine is administered under USG guidance.
The same procedure is performed on the contralateral side as well.
|
In the M-TAPA block group, with the patient in the supine position, a linear high-frequency linear ultrasound (USG) probe is angled to visualize the inferior surface of the costochondral junction at the level of the 10th costochondral cartilage.
Under sterile conditions, using the in-plane technique with a 22G 80 mm peripheral block needle, the needle is advanced posterior to the 10th costal cartilage by taking the lower edge of the cartilage in the sagittal plane as the midline.
After hydrodissection with 2-3 ml isotonic saline to confirm the site, 20 ml of 0.25% Bupivacaine is administered under USG guidance.
The same procedure is performed on the contralateral side as well.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total amount of opioid requirements
Time Frame: within 24 hours after the surgery
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The total tramadol use of the patients in 24 hours will be recorded.
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within 24 hours after the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rescue analgesia
Time Frame: within 24 hours after the surgery
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The rescue analgesia requirement and time of the need of the rescue analgesia requirement
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within 24 hours after the surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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intraoperative remifentanil consumption
Time Frame: during operation procedure]
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The total remifentanil use to be used in the maintenance of 0.05-0.2
mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
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during operation procedure]
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Visual Analogue Scale values
Time Frame: at 1st, 4th,8th 12th and 24th hours after the surgery]
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Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
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at 1st, 4th,8th 12th and 24th hours after the surgery]
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side effects such as nausea, vomiting and shoulder pain
Time Frame: within 24 hours after the surgery
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The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.a
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within 24 hours after the surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Serpil Sehirlioglu, MD, Gaziosmanpasa Research and Education Hospital
- Study Director: turan aydemir, MD, Gaziosmanpasa Research and Education Hospital
- Study Director: döndü moralar, MD, Gaziosmanpasa Research and Education Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaTREHTA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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