Morphine Consumption in Thoracotomy

Sponsor

Kocaeli University (Other)

Overall Status

Completed

CT.gov ID

NCT04999319

Collaborator

(none)

Enrollment

Location

Arms

15.3

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: PVB Procedure: ESPB	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 15, 2020

Actual Primary Completion Date :

Jan 5, 2022

Actual Study Completion Date :

Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PVB Group Paravertebral block administered group	Procedure: PVB Paravertebral block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.
Active Comparator: ESPB group Erector spinae plane block administered group	Procedure: ESPB Erector spinae plane block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.

Arm

Intervention/Treatment

Active Comparator: PVB Group

Paravertebral block administered group

Procedure: PVB

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

Active Comparator: ESPB group

Erector spinae plane block administered group

Procedure: ESPB

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

Outcome Measures

Primary Outcome Measures

Morphine consumption [Postoperative 24th hour]
Morphine consumption (mg) of patients with patient controlled analgesia device
NRS score [Postoperative 24th hour]
Numerating rating scale of the patients (between 0 and 10, 0 represents no pain and 10 represents the worst pain ever possible.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli Unversity	Kocaeli		Turkey

Sponsors and Collaborators

Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mustafa Duran, MD, Principal investigator., Kocaeli University

ClinicalTrials.gov Identifier:

NCT04999319

Other Study ID Numbers:

GOKAEK-2020/18.09

First Posted:

Aug 10, 2021

Last Update Posted:

Jan 26, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mustafa Duran, MD, Principal investigator., Kocaeli University

Postoperative pain

Thoracotomy

Paravertebral block

Erector spina plane block

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jan 26, 2022