NCT05094323

Brief Summary

Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 14, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 18, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

October 14, 2021

Last Update Submit

January 26, 2026

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Time to first analgesic requirement

    Assessed in minutes

    24 hours after surgery

Secondary Outcomes (1)

  • Postoperative pain intensity

    24 hours after surgery

Study Arms (3)

Group I

ACTIVE COMPARATOR

Patients will receive ultrasound-guided deep serratus anterior plane block.

Drug: Ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine

Group II

ACTIVE COMPARATOR

Patients will receive local wound infiltration (LWI).

Drug: Local wound infiltration with isobaric bupivacaine

Group III

PLACEBO COMPARATOR

Patients will receive ultrasound-guided thoracic paravertebral block.

Drug: Ultrasound-guided thoracic paravertebral block with isobaric bupivacaine

Interventions

Ultrasound-guided deep serratus anterior plane block with isobaric bupivacaineDRUG

Patients will receive ultrasound-guided deep serratus anterior plane block with isobaric bupivacaine.

Group I
Local wound infiltration with isobaric bupivacaineDRUG

Patients will receive local wound infiltration with isobaric bupivacaine.

Group II
Ultrasound-guided thoracic paravertebral block with isobaric bupivacaineDRUG

Patients will receive ultrasound-guided thoracic paravertebral block with isobaric bupivacaine.

Group III

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for uniportal VATS under general anesthesia, ASA status I-III, aged from 18 to 70 years old of both sex.

You may not qualify if:

  • Contraindications to regional block
  • Pregnancy
  • Body mass index (BMI) \> 30 Kg/m2
  • Psychiatric diseases
  • Severe renal, liver, or cardiac dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seham M. Moeen

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Seham M Moeen, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 26, 2021

Study Start

February 18, 2022

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

EG(1)