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

Primary Purpose

Postoperative Pain, Regional Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Unilateral ESP Block
Unilateral OSTAP Block
Injection of Local Anesthetic to Trocar Insertion
intravenous patient controlled analgesia
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Diskapi education and research hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Unilateral ESP Block

Unilateral OSTAP block

Injection of Local Anesthetic to Trocar Insertion

multimodal analgesia

Arm Description

Before 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.

Under 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.

After 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.

Perioperative 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.

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
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
Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.

Secondary Outcome Measures

postoperative nause and vomiting
The patient with nausea and vomiting will be recorded.

Full Information

First Posted
October 23, 2018
Last Updated
January 7, 2021
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03719157
Brief Title
Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy
Official Title
Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Regional Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral ESP Block
Arm Type
Active Comparator
Arm Description
Before 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.
Arm Title
Unilateral OSTAP block
Arm Type
Active Comparator
Arm Description
Under 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.
Arm Title
Injection of Local Anesthetic to Trocar Insertion
Arm Type
Active Comparator
Arm Description
After 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.
Arm Title
multimodal analgesia
Arm Type
Sham Comparator
Arm Description
Perioperative 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.
Intervention Type
Procedure
Intervention Name(s)
Unilateral ESP Block
Intervention Description
USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture
Intervention Type
Procedure
Intervention Name(s)
Unilateral OSTAP Block
Intervention Description
USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture
Intervention Type
Procedure
Intervention Name(s)
Injection of Local Anesthetic to Trocar Insertion
Intervention Description
Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.
Intervention Type
Drug
Intervention Name(s)
intravenous patient controlled analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours.
Time Frame
24 hours
Title
Postoperative pain scores: NRS
Description
Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
postoperative nause and vomiting
Description
The patient with nausea and vomiting will be recorded.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Diskapi education and research hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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