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Trial registered on ANZCTR


Registration number
ACTRN12622000831785
Ethics application status
Approved
Date submitted
21/04/2022
Date registered
14/06/2022
Date last updated
14/06/2022
Date data sharing statement initially provided
14/06/2022
Date results provided
14/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of postoperative pain after laparoscopic cholecystectomy
Scientific title
Comparison of ultrasound guided thoracic paravertebral block and erector spinae plane block for postoperative analgesia after laparoscopic cholecystectomy
Secondary ID [1] 306185 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic Cholecystectomy Operations 324888 0
Postoperative pain 324889 0
Condition category
Condition code
Anaesthesiology 322326 322326 0 0
Pain management
Surgery 323530 323530 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thoracic Paravertebral Block: Thoracic paravertebral block is the technique of injecting local anesthetic along side the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramen. This produces unilateral, segmental, somatic, and sympathetic nerve blockade, which is effective for anesthesia and in treating acute and chronic pain of unilateral origin from the chest and abdomen. (https://www.nysora.com/regional-anesthesia-for-specific-surgical-procedures/abdomen/thoracic-lumbar-paravertebral-block/) After the most prominent C7, processus spinosum in the cervical region was determined by palpation with the patients in a sitting position with their head slightly tilted forward, the relevant area was cleaned, we marked caudally one by one under US guidance. And 2,5-3 cm lateral of the T8 spinous process was marked as the injection point. At the needle insertion site, 2 mL of 2% lidocaine was infiltrated into the subcutaneous tissue.
After placing the linear US probe on the marked area for paravertebral block application in the longitudinal plane, consecutive transverse processes and the pleura, superior costotransverse ligament, and paravertebral area were determined. With the in-plane technique, an 80 mm 22 gauge peripheral block needle was directed caudally to the cephalad, and the needle tip was advanced into the thoracic paravertebral area until the superior costotransverse ligament was passed. After confirming there was no vascular interference with aspiration, 2-3 mL of 0,9% saline was administered and ventral movement of the parietal pleura was observed to confirm the needle location, and TPVB was administered by injecting 20 mL of 0.25% bupivacaine .
All TPVBs were performed by an anesthesiologist who has been working for at least 5 years.
The approximate time taken to perform the thoracic paravertebral 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.
Intervention code [1] 322590 0
Prevention
Intervention code [2] 322591 0
Treatment: Other
Comparator / control treatment
Erector Spinae Plane Block: Erector spinae plane block (ESPB) is an interfascial plane block first described in 2016 by Forero et al as an effective treatment method for the treatment of thoracic neuropathic pain. And this block uses for postoperative pain management after laparoscopic surgery. Trapezius, rhomboid, and erector spina muscles and consecutive transverse processes were determined with a linear US probe placed in the longitudinal plane to the area marked. With the in-plane technique, an 80 mm 22 gauge peripheral block needle was directed caudally to the cephalad, and we advanced the needle tip between the anterior fascia of the erector spina muscle group and the vertebral transverse process. After confirming that there was no vascular intervention by aspiration, 2-3 mL of 0.9% saline was administered and simultaneous monitoring of hydro dissection and distribution confirmed the needle location via US, ESPB was administered by injecting 20 mL of 0.25% bupivacaine.
All ESPBs were performed by an anesthesiologist who has been working for at least 5 years. The approximate time taken to perform the thoracic paravertebral 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.
Control group
Active

Outcomes
Primary outcome [1] 330094 0
The primary outcome measure of the study was to assess total analgesic drug consumption at the end of the 24 hours assessed using patient medical records.
Timepoint [1] 330094 0
at the postoperative 24th hour
Secondary outcome [1] 404858 0
The secondary outcome measure was to assess postoperative pain intensity using the VAS.
Timepoint [1] 404858 0
at the postoperative 24th hour
Secondary outcome [2] 409431 0
Postoperative complications assessed using patient medical records
Timepoint [2] 409431 0
at the postoperative 24th hour
Secondary outcome [3] 409432 0
block application time assessed using patient medical records
Timepoint [3] 409432 0
at the postoperative 24th hour
Secondary outcome [4] 409969 0
time of first additional analgesic requirement assessed using patient medical records
Timepoint [4] 409969 0
at the postoperative 24th hour

Eligibility
Key inclusion criteria
Patients aged between 18 and 70 years, with the American Society of Anesthesiologists' physical status classification score (ASA) I-II, without mental or psychiatric defect, who were scheduled for elective cholecystectomy between March 2021 and July 2021 are included in the study.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients outside the age range of 18-70 years, with ASA score above II, patients with local/systemic infection, severe arrhythmia, cardiac, hepatic and renal failure are not included in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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
Before the data collection phase, the required sample size for the research was determined using the G*Power 3.1 (Faul, Erdfelder, Lang and Buchner, 2007) program.
Under one tails conditions, when the effect size was 0.5, the alpha level was 0.05, and the power was 80%, the sample size was 51 for each group, a total of 102.
We examined normality assumptions of continuous variables with skewness and kurtosis (Skewness and Kurtosis) coefficients, Kolmogorov-Smirnov test, and Histogram. Mean and standard deviation (Mean±SD.), median (minimum-maximum) values in the descriptive statistics of continuous variables; in the definition of categorical variables, frequency (n) and percentage (%) values are given. The Mann–Whitney U test was used to compare the non-normally distributed continuous variables with the two-level variables, and the relationships between the categorical variables were analyzed using Pearson’s Chi-square Test and Fisher’s exact analysis. IBM SPSS.23 program was used in all analyzes and the p<0.05 value was accepted as the level of significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
31/05/2021
Date of last data collection
Anticipated
Actual
1/06/2021
Sample size
Target
110
Accrual to date
Final
102
Recruitment outside Australia
Country [1] 24731 0
Turkey
State/province [1] 24731 0
AFYONKARAHISAR

Funding & Sponsors
Funding source category [1] 310320 0
Self funded/Unfunded
Name [1] 310320 0
Dr. Bilal Atilla Bezen
Country [1] 310320 0
Turkey
Primary sponsor type
University
Name
Afyonkarahisar Health Sciences University
Address
Afyonkarahisar Health Sciences University, Faculty of Medicine
Zafer Saglik Külliyesi
Dörtyol Mah. 2078 Sok. No:3

AFYONKARAHISAR/TURKEY
Country
Turkey
Secondary sponsor category [1] 312625 0
None
Name [1] 312625 0
Address [1] 312625 0
Country [1] 312625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309982 0
Afyonkarahisar Health Sciences University Ethics Committee
Ethics committee address [1] 309982 0
Ethics committee country [1] 309982 0
Turkey
Date submitted for ethics approval [1] 309982 0
19/02/2021
Approval date [1] 309982 0
26/02/2021
Ethics approval number [1] 309982 0
170

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

Contacts
Principal investigator
Name 116070 0
Dr Bilal Atilla BEZEN
Address 116070 0
Afyonkarahisar Saglik Bilimleri Üniversitesi Hastanesi
Ali Çetinkaya Kampusü
Dörtyol mah. 2078 sok. No. 3/4 AFYONKARAHISAR
Country 116070 0
Turkey
Phone 116070 0
+905419671370
Fax 116070 0
Email 116070 0
drbilalatilla@gmail.com
Contact person for public queries
Name 116071 0
Bilal Atilla BEZEN
Address 116071 0
Afyonkarahisar Saglik Bilimleri Üniversitesi Hastanesi
Ali Çetinkaya Kampusü
Dörtyol mah. 2078 sok. No. 3/4 AFYONKARAHISAR
Country 116071 0
Turkey
Phone 116071 0
+905419671370
Fax 116071 0
Email 116071 0
drbilalatilla@gmail.com
Contact person for scientific queries
Name 116072 0
Bilal Atilla BEZEN
Address 116072 0
Afyonkarahisar Saglik Bilimleri Üniversitesi Hastanesi
Ali Çetinkaya Kampusü
Dörtyol mah. 2078 sok. No. 3/4 AFYONKARAHISAR
Country 116072 0
Turkey
Phone 116072 0
+905419671370
Fax 116072 0
Email 116072 0
drbilalatilla@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No consent was obtained for the sharing of individual participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15806Study protocol  drbilalatilla@gmail.com
15809Ethical approval  klinikarastirmalar@afsu.edu.tr



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.