Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03719157

Enrollment

100

Registered

2018-10-25

Start date

2019-04-01

Completion date

2019-10-01

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Regional Anesthesia

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.

Interventions

PROCEDUREUnilateral ESP Block

USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture

PROCEDUREUnilateral OSTAP Block

USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture

PROCEDUREInjection of Local Anesthetic to Trocar Insertion

Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.

DRUGintravenous patient controlled analgesia

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* ASA Status 1-2 patients

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative opioid consumption	24 hours	Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours.
Postoperative pain scores: NRS	24 hours	Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.

Secondary

Measure	Time frame	Description
postoperative nause and vomiting	24 hours	The patient with nausea and vomiting will be recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026