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Morphine Consumption in Thoracotomy

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

PVB

ESPB

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Postoperative pain, Thoracotomy, Paravertebral block, Erector spina plane block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA I-III patients undergo elective thoracotomy surgeries.

Exclusion Criteria:

Obesity (BMI > 35 kg/m2)
Infection of the skin at the site of the needle puncture area
Patients with known allergies to any of the study drugs
Coagulopathy

Sites / Locations

Kocaeli Unversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PVB Group

ESPB group

Arm Description

Paravertebral block administered group

Erector spinae plane block administered group

Outcomes

Primary Outcome Measures

Morphine consumption

Morphine consumption (mg) of patients with patient controlled analgesia device

NRS score

Numerating rating scale of the patients (between 0 and 10, 0 represents no pain and 10 represents the worst pain ever possible.

Secondary Outcome Measures

Full Information

NCT ID

NCT04999319

First Posted

August 5, 2021

Last Updated

January 25, 2022

Sponsor

Kirsehir Ahi Evran University

1. Study Identification

Unique Protocol Identification Number

NCT04999319

Brief Title

Morphine Consumption in Thoracotomy

Official Title

Comparison of Morphine Consumption at Postoperative 24th Hour in Thoracotomy: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

January 5, 2022 (Actual)

Study Completion Date

January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are associated with high levels of pain. With the use of ultrasound, many regional anesthesia techniques were described to provide effective postoperative analgesia. The aim of this study was to compare the postoperative effect of paravertebral block (PVB) and erector spinal plane block (ESPB) in thoracotomies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Postoperative pain, Thoracotomy, Paravertebral block, Erector spina plane block

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PVB Group

Arm Type

Active Comparator

Arm Description

Paravertebral block administered group

Arm Title

ESPB group

Arm Type

Active Comparator

Arm Description

Erector spinae plane block administered group

Intervention Type

Procedure

Intervention Name(s)

PVB

Intervention Description

Paravertebral block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.

Intervention Type

Procedure

Intervention Name(s)

ESPB

Intervention Description

Erector spinae plane block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.

Primary Outcome Measure Information:

Title

Morphine consumption

Description

Morphine consumption (mg) of patients with patient controlled analgesia device

Time Frame

Postoperative 24th hour

Title

NRS score

Description

Numerating rating scale of the patients (between 0 and 10, 0 represents no pain and 10 represents the worst pain ever possible.

Time Frame

Postoperative 24th hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I-III patients undergo elective thoracotomy surgeries. Exclusion Criteria: Obesity (BMI > 35 kg/m2) Infection of the skin at the site of the needle puncture area Patients with known allergies to any of the study drugs Coagulopathy

Facility Information:

Facility Name

Kocaeli Unversity

City

Kocaeli

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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Morphine Consumption in Thoracotomy

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