- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06768385
Comparison of Two Regional Blocks For Pain Treatment After Laparoscopic Cholecystectomy
Comparison of The Efficacy of TAP and TAPA (Thoracoabdominal Nerve Blockage With Perichondrial Approach) Blocks For Pain Treatment After Laparoscopic Cholecystectomy
Study Overview
Status
Conditions
Detailed Description
Laparoscopic cholecystectomy (LC) is one of the most frequently performed surgical operations and the postoperative hospital stay is short (1). Although there is less postoperative pain in laparoscopic surgeries than in open surgeries, severe pain is a common complaint, especially in the first 24 hours. Therefore, various modalities have been tried to reduce postoperative pain (2).
In recent years, the effectiveness of ultrasound-guided interfascial plane blocks has come to the fore in the field of regional anaesthesia and pain management. There has always been a search for a regional anaesthesia method that provides effective analgesia of the anterolateral part of the upper abdomen. In addition to anterolateral blocks, such as pectoralis nerve block (PECS) and serratus intercostal plane block (SIBP), other posterior blocks like quadratus lumborum blocks and erector spinus plane blocks have been used for this purpose. TAP block is the application of local anaesthetic agents into the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen. This procedure, in which the anterior branches of the 7th-12th thoracic intercostal and first lumbar (L1) nerves are blocked, is frequently used to provide pain control after operations involving the abdominal and inguinal regions (3,4).
Recently introduced thoracoabdominal nerve blockage with perichondrial approach (TAPA) has been reported to provide sensory blockade between midaxillary line and midabdominal/sternum in dermatomes between T5-T12 (5,6). In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium. In this way the anterior and lateral cutaneous branches of the intercostal nerves are blocked. In light of this information, our hypothesis is that the analgesic effect will be greater in TAPA block since the lateral branches of the intercostal nerves are also affected.
The aim of our study is to compare the postoperative analgesic efficacies of TAP and TAPA blocks to be applied to patients undergoing laparoscopic cholecystectomy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Asia
-
Istanbul, Asia, Turkey, 34668
- SBU Sultan Abdulhamid Han
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Patients classified as I-II-III by the American Society of Anesthesiologists (ASA) and aged between 20 and 70 years were included in the study
Exclusion Criteria:Patients were excluded if they were younger than 20 years, older than 70 years, had ASA physical status classification IV, were pregnant or had a body mass index (BMI) ≥ 35 kg m-2, had a skin infection at the needle puncture site, had a history of previous abdominal surgery or trauma, were known to be allergic to any of the study drugs, had used any analgesic within 24 hours before surgery, had a history of chronic opioid use, alcohol or drug use, were receiving antithrombotic therapy, and had abnormal coagulation parameters.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group T
After general anesthesia induction, TAP block was applied to Group T. TAP block is the application of local anaesthetic agents to the neurofascial space between the internal oblique and transversus abdominis muscle layers located in the anterolateral region of the abdomen.
|
: It was performed under USG guidance using 30 ml of 0.25% bupivacaine with an 80 mm insulated peripheral block needle.
Local anaesthetic was applied between the upper fascia of the transversus abdominus muscle and the fascia of the internal oblique muscle at the midpoint of the distance between the costal margin and the iliac crest in the midaxillary line under USG imaging guidance.
|
|
Active Comparator: group P
TAPA block was applied to Group P. In TAPA block, local anesthesia is applied to two points, the upper part of the chondrium and the lower part of the chondrium.
|
Under USG guidance, 20 ml of 0.25% bupivacaine was administered between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue at the level of the 9th and 10th ribs (arcus costarum) in the midclavicular line with an 80 mm insulated peripheral block needle.
Then, 10 ml of 0.25% bupivacaine was injected into the upper fascia of the costochondral tissue and the lower fascia of the external oblique muscle.
The block was performed by following the needle path in the ultrasound image.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative analgesic efficacy
Time Frame: At the postoperative 2nd, 6th, 12th and 24th hours, the patient's request and administrations from the patient-controlled analgesia (PCA) device, total tramadol dose and the first additional analgesic drug if needed, and application times were recorded.
|
NRS (Numerical Rating Scale) was used for pain monitoring.
Patients were informed about the NRS assessment for pain.
It was stated that a score of 0 meant no pain and a score of 10 meant the worst pain imaginable.
After the first assessment hour when NRS >4 was noted in patients, IV analgesia treatment was started (dexketoprofen 50 mg IV as additional analgesic).
If NRS <4 and the patient did not request analgesic, the drug dose was skipped.
|
At the postoperative 2nd, 6th, 12th and 24th hours, the patient's request and administrations from the patient-controlled analgesia (PCA) device, total tramadol dose and the first additional analgesic drug if needed, and application times were recorded.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
presence of nausea-vomiting
Time Frame: the postoperative 2nd, 6th, 12th and 24th hours
|
presence of nausea-vomiting recorded at the postoperative 2nd, 6th, 12th and 24th hours
|
the postoperative 2nd, 6th, 12th and 24th hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dilek M Yamac, Sultan Abdülhamid Han education and research hospital
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
- SBU-ANESTHESİA-DMY-02
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
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.
Clinical Trials on Pain, Postoperative
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Transversus abdominis plane (TAP) block
-
Samsun UniversityCompletedCaesarean Section | Acute Pain ManagementTurkey
-
Ankara Ataturk Sanatorium Training and Research...RecruitingPostoperative Pain | Erector Spinae Plane Block | Abdominoplasty | Transversus Abdominis Plane (TAP) BlockTurkey
-
Nordsjaellands HospitalCompletedPostoperative PainDenmark
-
Helwan UniversityCompletedTransversus Abdominis Plane Block | Herniorrhaphy | Spinal AnaesthesiaEgypt
-
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...Maltepe UniversityCompletedPostoperative Pain ManagementTurkey (Türkiye)
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedPostoperative Complications | Postoperative Pain | Analgesia | Regional Anesthesia MorbidityTurkey
-
Northwestern UniversityCompletedPain | SurgeryUnited States
-
Sanliurfa Education and Research HospitalNot yet recruitingSleeve Gastrectomy | External Oblique Intercostal Plane Block | Subcostal Transverse Abdominis Plane BlockTurkey (Türkiye)
-
Mackay Memorial HospitalRecruitingLaparoscopy | Anesthesia and Analgesia | Autonomic Nervous System | Nerve Block | EEGTaiwan
-
Ain Shams UniversityCompletedMobility | Transversus Abdominis Plane Block | Wearable Device | Anterior Iliac Grafting | Regional Block TechniqueEgypt