NCT05506761

Brief Summary

The aim of this study is to assess the quality of analgesic efficacy and improvement of pulmonary function in patients with fracture ribs receiving either continuous rhomboid intercostal block combined with sub-serratus block or continuous erector spinae plane block by comparing and evaluating the differences between the two techniques.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 17, 2022

Last Update Submit

August 17, 2022

Conditions

Rib Fractures

Keywords

Rib FracturesIntercostal nerve block

Outcome Measures

Primary Outcomes (1)

  • Total opioid analgesic consumption per day

    4 days

Secondary Outcomes (7)

  • change in pain scores by Numerical rating score (NRS) after the procedure

    4 days

  • Time to First rescue analgesic request.

    4 days

  • Patient satisfaction.

    4 days

  • Changes in heart rate.

    4 days

  • Changes in mean arterial blood pressure.

    4 days

  • +2 more secondary outcomes

Study Arms (3)

Group I

NO INTERVENTION

This group includes patients with rib fractures receiving patient-controlled analgesia.

Group II

EXPERIMENTAL

This group includes patients with rib fractures receiving continuous ultrasound-guided erector spinae plane block.

Procedure: ultrasound-guided erector spinae plane block

Group III

EXPERIMENTAL

This group includes patients with rib fractures receiving continuous ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block.

Procedure: ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block

Interventions

ultrasound-guided erector spinae plane blockPROCEDURE

Patients will receive 20 ml plain bupivacaine 0.25 % bolus, then 10 ml per hour plain bupivacaine 0.125 % continuous infusion via ultrasound-guided erector spinae plane block

Group II
ultrasound-guided rhomboid intercostal block combined with sub-serratus plane blockPROCEDURE

Patients will receive 20 ml plain bupivacaine 0.25 % bolus, then 10 ml per hour plain bupivacaine 0.125 % continuous infusion via ultrasound-guided rhomboid intercostal block combined with sub-serratus plane block

Group III

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients between 21 - 60 years.
  • Patients with blunt chest trauma.
  • Multiple fracture ribs (at least 3 ribs).
  • Patients with acute trauma less than 48 hours.

You may not qualify if:

  • Patients with major trauma outside the chest wall e.g., severe traumatic brain injury or major abdominal visceral injuries.
  • Patients with bilateral rib fractures.
  • Patients that are intubated and mechanically ventilated.
  • Pregnant Individuals.
  • Patients with local deformity or infection at the site of injection.
  • Sensitivity to local anesthetic drugs.
  • Patients with flail chest.
  • Patients with Suspected or diagnosed coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, Egypt

RECRUITING

Related Publications (8)

  • Peek J, Beks RB, Hietbrink F, Heng M, De Jong MB, Beeres FJP, Leenen LPH, Groenwold RHH, Houwert RM. Complications and outcome after rib fracture fixation: A systematic review. J Trauma Acute Care Surg. 2020 Aug;89(2):411-418. doi: 10.1097/TA.0000000000002716.

    PMID: 32282759BACKGROUND

  • Bachoumas K, Levrat A, Le Thuaut A, Rouleau S, Groyer S, Dupont H, Rooze P, Eisenmann N, Trampont T, Bohe J, Rieu B, Chakarian JC, Godard A, Frederici L, Gelinotte S, Joret A, Roques P, Painvin B, Leroy C, Benedit M, Dopeux L, Soum E, Botoc V, Fartoukh M, Hausermann MH, Kamel T, Morin J, De Varax R, Plantefeve G, Herbland A, Jabaudon M, Duburcq T, Simon C, Chabanne R, Schneider F, Ganster F, Bruel C, Laggoune AS, Bregeaud D, Souweine B, Reignier J, Lascarrou JB. Epidural analgesia in ICU chest trauma patients with fractured ribs: retrospective study of pain control and intubation requirements. Ann Intensive Care. 2020 Aug 27;10(1):116. doi: 10.1186/s13613-020-00733-0.

    PMID: 32852675BACKGROUND

  • Ostermann RC, Joestl J, Lang N, Tiefenboeck TM, Ohnesorg S, Platzer P, Hofbauer M. Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome. Injury. 2021 Jun;52(6):1316-1320. doi: 10.1016/j.injury.2021.02.033. Epub 2021 Feb 17.

    PMID: 33663803BACKGROUND

  • Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: An overview. Chin J Traumatol. 2020 Jun;23(3):125-138. doi: 10.1016/j.cjtee.2020.04.003. Epub 2020 Apr 20.

    PMID: 32417043BACKGROUND

  • Warfield DJ Jr, Barre S, Adhikary SD. Current understanding of the fascial plane blocks for analgesia of the chest wall: techniques and indications update for 2020. Curr Opin Anaesthesiol. 2020 Oct;33(5):692-697. doi: 10.1097/ACO.0000000000000909.

    PMID: 32826623BACKGROUND

  • O'Connell KM, Patel KV, Powelson E, Robinson BRH, Boyle K, Peschman J, Blocher-Smith EC, Jacobson L, Leavitt J, McCrum ML, Ballou J, Brasel KJ, Judge J, Greenberg S, Mukherjee K, Qiu Q, Vavilala MS, Rivara F, Arbabi S. Use of regional analgesia and risk of delirium in older adults with multiple rib fractures: An Eastern Association for the Surgery of Trauma multicenter study. J Trauma Acute Care Surg. 2021 Aug 1;91(2):265-271. doi: 10.1097/TA.0000000000003258.

    PMID: 33938510BACKGROUND

  • Jiang CW, Liu F, Zhou Q, Deng W. Comparison of rhomboid intercostal nerve block, erector spinae plane block and serratus plane block on analgesia for modified radical mastectomy: A prospective randomised controlled trial. Int J Clin Pract. 2021 Oct;75(10):e14539. doi: 10.1111/ijcp.14539. Epub 2021 Jul 2.

    PMID: 34133831BACKGROUND

  • Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.

    PMID: 33403545BACKGROUND

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Central Study Contacts

Ahmed G. ElNawagy

CONTACT

01158170077ahmed.nawagy@med.tanta.edu.eg

Study Design

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

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 18, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)