Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001305415
Ethics application status
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Approved
Date submitted
Help: Date submitted
20/06/2025
Date registered
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24/11/2025
Date last updated
Help: Date last updated
24/11/2025
Date data sharing statement initially provided
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24/11/2025
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Comparison of the effects of two differents blocks on postoperative analgesia in laparoscopic cholecystectomy
Scientific title
Comparison of the effects of modified thoracoabdominal nerve block through perichondrial approach and erector spinae plane block on postoperative analgesia in laparoscopic cholecystectomy
Additional trial identifiers [1] 314197 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Anaesthesiology 337070 0
Condition category
Condition code
Anaesthesiology 333508 333508 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Modified thoracoabdominal nerves block through perichondrial approach:
Modified thoracoabdominal nerves block through perichondrial approach (m-tapa) is a type of block used for postoperative analgesia in various abdominal surgeries, reported to provide abdominal analgesia by blocking both the anterior and lateral cutaneous branches of the thoracabdominal nerves by applying local anesthesia to the underside of the costochondral chondrium at the 9th and 10th costal levels.
Before surgery began, after ensuring appropriate sterilization, a linear ultrasonography (USG) probe was aseptically inserted into the costochondral angle at the level of the 9th and 10th ribs in the sagittal plane. The transverse abdominis muscle, internal oblique muscle, and external oblique muscle were visualized. The probe was then angled deeply to visualize the underside of the chondrium. Using the in-plane technique, an 80 mm 22-gauge peripheral blocking needle (Stimuplex®, B Braun, Melsungen, Germany) was guided caudally to the cephalad plane, advancing the needle tip to the underside of the chondrium. After confirming the absence of vascular access by aspiration, an M-TAPA block was performed by injecting 20 ml of 0.25% bupivacaine (Buvasin vial, Vem, Istanbul, Türkiye).
All M-tapas were performed by an anesthesiologist who has been working for at least 5 years.
Anesthesia was maintained with 50% O2 + 50% air with 6% desflurane (Suprane®, Baxter, USA), fentanyl, and rocuronium titration. Any complications related to the block were recorded during intraoperative follow-up. At the end of surgery, patients were antagonized with 2 mg/kg sugammadex (Bridion®, Sanofi, Tekirdag, Turkey) after the inhaled agent was removed and the muscle relaxant effect was antagonized. After extubation, they were taken to the postoperative recovery room. Arrival time to the recovery room was considered 0. The first VAS assessment of patients who underwent M-TAPA was performed here.Any side effects or complications such as hypotension, vascular puncture, paresthesia, and local anesthetic toxicity that developed during block application were documented. Patients who met the recovery criteria were followed up in the general surgery clinic. Demographic data obtained from postoperative recovery room and ward follow-ups of all patients, postoperative rest and dynamic VAS scores at 0, 2, 4, 6, 8, 12, and 24 hours, and patient satisfaction at 24 hours were reviewed and recorded. The time of first analgesic use at 24 hours postoperatively was recorded on the case report form.
Intervention code [1] 330799 0
Treatment: Other
Description of the comparator or control
The erector spinae plane block (ESPB) was first described in 2016 by Forero et al. to treat thoracic neuropathic pain. It is performed by applying local anesthesia to the interfascial space between the transverse process of the vertebra and the erector spinae muscles. Local anesthesia administered to this area spreads to multiple paravertebral spaces. By blocking the dorsal and ventral rami, it blocks somatic and visceral pain.Patients were seated in a sitting position with their heads slightly flexed. The most prominent C7 spinous process in the cervical region was identified by palpation. The injection point was marked 2.5-3 cm right-lateral to the T8 spinous process. 1 ml of 2% lidocaine was infiltrated into the subcutaneous tissue at the needle entry site. After appropriate sterilization conditions were achieved, a linear ultrasound probe was placed in the marked area in a longitudinal plane using aseptic technique to identify the consecutive transverse processes and the erector spinae muscle. Using the in-plane technique, an 80 mm 22-gauge peripheral block needle (Stimuplex®, B Braun, Melsungen, Germany) was guided cephalad to caudal, advancing the needle tip between the deep fascia of the erector spinae muscle group and the vertebral transverse process. After confirming the absence of vascular interference by aspiration, 1 ml of physiological saline was administered, and the needle location was confirmed by simultaneously monitoring the distribution with hydrodissection via USG, and ESP block was applied by injecting 20 ml of 0.25% bupivacaine (BuVASin vial, Vem, Istanbul, Türkiye).
All ESPBs were performed by an anesthesiologist who has been working for at least 5 years. The approximate time taken to perform the ESP block is 10 min and performed 10 minutes before commencing surgery. The suitability of the block was evaluated with the loss of cold sensation up and down two levels in the mid-clavicular line.
Any side effects or complications such as hypotension, vascular puncture, paresthesia, and local anesthetic toxicity that developed during block application were documented. Patients who met the recovery criteria were followed up in the general surgery clinic. Demographic data obtained from postoperative recovery room and ward follow-ups of all patients, postoperative rest and dynamic VAS scores at 0, 2, 4, 6, 8, 12, and 24 hours, and patient satisfaction at 24 hours were reviewed and recorded. The time of first analgesic use at 24 hours postoperatively was recorded on the case report form.
Control group
Active

Outcomes
Primary outcome [1] 341885 0
Visual pain scale (VAS) was used to assess the pain intensity of the patients.
Timepoint [1] 341885 0
Baseline postoperative 24 hr.Measurements were made at postoperative 0. and 2., 4., 8., 12., 24., hours.
Secondary outcome [1] 450278 0
First analgesic consumption time
Timepoint [1] 450278 0
postoperative 24th hour.
Secondary outcome [2] 454567 0
The length of hospital stay was obtained from medical records.
Timepoint [2] 454567 0
postoperatave discharge point
Secondary outcome [3] 454568 0
Patient Satisfaction from analgesic theraphy
Timepoint [3] 454568 0
postoperative 24th hour

Eligibility
Key inclusion criteria
The patients aged between 18 and 70, classified as American Society of Anesthesiologists (ASA) I-III, who were scheduled for elective cholecystectomy.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Patients outside the age range of 18-70, those with ASA scores above III, local or systemic infections,mental or psiychiatric disorders serious arrhythmias, and cardiac, hepatic, or renal failure were excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the allocation schedule owner located in the administration center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be evaluated using IBM SPSS Statistics version 22. Normality of variables will be determined using the histogram or Kolmogorov-Smirnov or Shapiro-Wilk test.
The Student's t-test will be used to compare continuous variables when the normality assumption is met, and the Mann-Whitney U test will be used when the normality assumption is not met. The Pearson chi-square test will be used to compare categorical variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/12/2022
Date of last participant enrolment
Anticipated
Actual
1/05/2023
Date of last data collection
Anticipated
Actual
2/05/2023
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 27129 0
Turkey
State/province [1] 27129 0
Afyonkarahisar/TURKIYE

Funding & Sponsors
Funding source category [1] 319556 0
Self funded/Unfunded
Name [1] 319556 0
Country [1] 319556 0
Primary sponsor type
University
Name
Afyonkarahisar Health Science University
Address
Country
Turkey
Secondary sponsor category [1] 322431 0
None
Name [1] 322431 0
Address [1] 322431 0
Country [1] 322431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317320 0
Afyonkarahisar Health Sciences University Ethics Committee
Ethics committee address [1] 317320 0
Ethics committee country [1] 317320 0
Turkey
Date submitted for ethics approval [1] 317320 0
08/12/2022
Approval date [1] 317320 0
12/12/2022
Ethics approval number [1] 317320 0
Desicion date:2012/12, number:585

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140690 0
Dr ozge ozturk dinc
Address 140690 0
university of afyonkarahisar health science hospital, block B,dortyol st.03200 afyon/turkey
Country 140690 0
Turkey
Phone 140690 0
+90 5535243617
Fax 140690 0
Email 140690 0
[email protected]
Contact person for public queries
Name 140691 0
ozge ozturk dinc
Address 140691 0
university of afyonkarahisar health science hospital, block B,dortyol st.03200 afyon/turkey
Country 140691 0
Turkey
Phone 140691 0
+90 5535243617
Fax 140691 0
Email 140691 0
[email protected]
Contact person for scientific queries
Name 140692 0
ozge ozturk dinc
Address 140692 0
university of afyonkarahisar health science hospital, block B,dortyol st.03200 afyon/turkey
Country 140692 0
Turkey
Phone 140692 0
+90 5535243617
Fax 140692 0
Email 140692 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.