Effect of Continue RISS Block in Thoracotomy

NCT ID: NCT04443556

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-02-15

Brief Summary

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Thoracotomy is one of the most painful surgery. Acute postoperative pain increases postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic pain syndrome. This study aimed to assess the efficacy of continuous rhomboid intercostal and subserratus plane (RISS) block by inserting a catheter under direct vision for controlling acute thoracotomy pain.

Detailed Description

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Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue RISS block. First catheter tip will be place towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be place in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours.

Conditions

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Postoperative Pain Thoracotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group Rhomboid Intercostal and Subserratus Plane Block

Standart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue the RISS block. First catheter tip will be placed towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be placed in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours. Also an IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.

IV PCA

Intervention Type OTHER

An IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.

Control Group

Standart postoperative analgesia

Group Type OTHER

IV PCA

Intervention Type OTHER

An IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.

Interventions

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Tramadol

Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue the RISS block. First catheter tip will be placed towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be placed in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours. Also an IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.

Intervention Type DRUG

IV PCA

An IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.

Intervention Type OTHER

Other Intervention Names

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Local anesthetic

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age undergoing elective thoracic surgery
* American Society of Anesthesiologists (ASA) physical status I-III grade

Exclusion Criteria

* Patient refusal
* History of psychiatric and cognitive disorders.
* Patients allergic to the drugs used in the study
* Emergent surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Betul Kozanhan

Ass.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Konya Education and Training Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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RISS THORACOTOMY

Identifier Type: -

Identifier Source: org_study_id

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