Rhomboid Intercostal Block for Video Assisted Thoracic Surgery

Sponsor
Medipol University (Other)
Overall Status
Completed
CT.gov ID
NCT04428216
Collaborator
(none)
50
1
2
22.8
2.2

Study Details

Study Description

Brief Summary

Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.

Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.

Condition or Disease Intervention/Treatment Phase
  • Other: Group RIB
N/A

Detailed Description

Following Video Assisted Thoracic Surgery Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS prodecures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.

Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several surgeries like thoracotomy.

The aim of this study is to evaluate the efficacy US-guided Rhomboid intercostal block compared to no intervention control group for postoperative analgesia management after VATS. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to block (pneumothorax, hematoma etc).

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There are two models for this study. The first group is rhomboid intercostal block group. The second one is no intervention control groupThere are two models for this study. The first group is rhomboid intercostal block group. The second one is no intervention control group
Masking:
Single (Outcomes Assessor)
Masking Description:
The anesthesiologist who performs postoperative pain evaluation will not know the group.
Primary Purpose:
Treatment
Official Title:
The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block for Pain Management Following Video Assisted Thoracic Surgery
Actual Study Start Date :
Jul 7, 2020
Actual Primary Completion Date :
May 30, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group RIB = Rhomboid intercostal block group

In group RIB, RIB block will be performed with patients in the lateral decubitus position. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 20 ml 0,25% bupivacaine will be injected into the fascial plane.

Other: Group RIB
In group RIB, RIB block will be performed. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

No Intervention: Group C = Control group

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption [Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours]

    The primary aim is to compare perioperative and postoperative opioid consumption

Secondary Outcome Measures

  1. Pain scores (Visual analogue scores-VAS) [Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.]

    Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • American Society of Anesthesiologists (ASA) classification I-II

  • Scheduled for VATS under general anesthesia

Exclusion Criteria:
  • history of bleeding diathesis,

  • receiving anticoagulant treatment,

  • known local anesthetics and opioid allergy,

  • infection of the skin at the site of the needle puncture,

  • pregnancy or lactation,

  • patients who do not accept the procedure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Hospital Istanbul Bagcilar Turkey 34070

Sponsors and Collaborators

  • Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bahadir Ciftci, Primary researcher, Medipol University
ClinicalTrials.gov Identifier:
NCT04428216
Other Study ID Numbers:
  • Medipol Hospital 13
First Posted:
Jun 11, 2020
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bahadir Ciftci, Primary researcher, Medipol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022