NCT05218746

Brief Summary

The aim of this study is to compare serratus anterior plane block and erector spinae plane block for postoperative analgesia after VATS as measured by the duration till 1st requirement of analgesia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

January 31, 2022

Last Update Submit

February 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • the duration till 1st requirement of analgesia

    The time from the end of the operation till Visual analogue score more than 3

    postoperative first day

Secondary Outcomes (1)

  • Analgesic consumption

    postoperative first day

Study Arms (2)

Serratus anterior block

EXPERIMENTAL

Regional analgesic block of anterolateral chest wall

Procedure: Serratus anterior plane block

Erector spinae block

EXPERIMENTAL

Regional analgesic block for the whole chest wall

Procedure: Erector spinae block

Interventions

High-frequency linear transducer will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, Then, using ultrasound guidance, the needle will be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib . one millileter normal saline will be injected to confirm placement and to hydro-dissect the fascial layers and open the potential space.

Serratus anterior block

A high-frequency linear ultrasound probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes is identified, spinal needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle.

Erector spinae block

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with American Society of Anesthesiologists (ASA) physical status 1-3 --
  • scheduled for VATS .

You may not qualify if:

  • ≤20 or ≥80 years old.
  • Refusing to participate in the study .
  • History of allergy to the medications used in the study.
  • Contraindication to regional anesthesia (including coagulopathy and local infection).
  • Severe hepatic impairement (serum protein \< 3g/dl and serum bilirubin \> 3mg/dl) .
  • Renal dysfunction (as determined by creatinine levels greater than 2mg/dl or predicted creatinine clearance (CLcr)\<50ml/min).
  • Psychiatric disorder.
  • Pregnancy.
  • Body mass index (BMI) ≥40 or ≤18 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

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

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 1, 2022

Study Start

February 1, 2022

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share