Effect of Continue RISS Block in Thoracotomy

NCT04443556 | Completed

• 1 other identifier: RISS THORACOTOMY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).

  postoperative 48 hour

Secondary Outcomes (1)

• Analgesic consumption

  Postoperative 48 hour

Study Arms (2)

Group Rhomboid Intercostal and Subserratus Plane Block

ACTIVE COMPARATOR

Standart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block

Drug: Tramadol; Other: IV PCA

Control Group

OTHER

Standart postoperative analgesia

Other: IV PCA

Interventions

Tramadol 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.

Also known as: Local anesthetic

Group Rhomboid Intercostal and Subserratus Plane Block

IV PCA 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; Group Rhomboid Intercostal and Subserratus Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient refusal
• History of psychiatric and cognitive disorders.
• Patients allergic to the drugs used in the study
• Emergent surgery

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Education and Training Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Anesthetics, Local; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: August 31, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 15, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

TU (1)