Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy
1 other identifier
interventional
100
1 country
1
Brief Summary
Main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Apr 2019
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJanuary 11, 2021
January 1, 2021
5 months
October 23, 2018
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Postoperative opioid consumption
Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours.
24 hours
Postoperative pain scores: NRS
Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.
24 hours
Secondary Outcomes (1)
postoperative nause and vomiting
24 hours
Study Arms (4)
Unilateral ESP Block
ACTIVE COMPARATORBefore general anaesthesia, Ultrasound guided unilateral ESP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
Unilateral OSTAP block
ACTIVE COMPARATORUnder general anaesthesia, Ultrasound guided unilateral OSTAP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
Injection of Local Anesthetic to Trocar Insertion
ACTIVE COMPARATORAfter the laparoscopic surgery was completed, the trocar incision sites were closed. Following the infiltration rules, local anesthetic (15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine) was applied to the trocar sites of skin, fascia, muscle, and preperitoneal area by the surgical team after the operation. A total of 20 mL of local anesthetic was used, with 6 mL for trocar sites of 10 mm, and 4 mL for trocar sites of 5 mm .Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
multimodal analgesia
SHAM COMPARATORPerioperative and postoperative routine analgesic protocol will be performed with no additional regional anesthesia method.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.
Interventions
USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture
USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture
Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.
All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.
Eligibility Criteria
You may not qualify if:
- Patients with a body mass index (BMI) of \>40kg/m2
- ASA score of \>III
- Previous abdominal surgery
- Pregnant or breastfeeding patients
- Patients with coagulopathy
- Known local anesthetic allergy
- infection at the injection site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi education and research hospital
Ankara, 06010, Turkey (Türkiye)
Related Publications (1)
Nalbant B, Donmez A, Altinsoy S, Kavak Akelma F. Efficacy of OSTAP, ESP block, trocar site local anesthetic injection in elective laparoscopic cholecystectomy: A randomized controlled trial. Medicine (Baltimore). 2025 Aug 1;104(31):e43607. doi: 10.1097/MD.0000000000043607.
PMID: 40760576DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Doctor
Study Record Dates
First Submitted
October 23, 2018
First Posted
October 25, 2018
Study Start
April 1, 2019
Primary Completion
September 1, 2019
Study Completion
October 1, 2019
Last Updated
January 11, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share