NCT06431880

Brief Summary

The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

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

May 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

May 16, 2024

Last Update Submit

August 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

    Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the numeric rating scale \< 4. numeric rating scale will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.

    24 hours postoperatively

Secondary Outcomes (6)

  • Intraoperative fentanyl consumption

    Intraoperative

  • Mean arterial pressure

    Till the end of surgery

  • Heart rate

    Till the end of surgery

  • Time to the 1st rescue analgesia

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • +1 more secondary outcomes

Study Arms (2)

External oblique intercostal plane block

EXPERIMENTAL

Patients will receive external oblique intercostal plane block.

Other: External oblique intercostal plane block

Thoracic paravertebral block

EXPERIMENTAL

Patients will receive thoracic paravertebral block.

Other: Thoracic paravertebral block

Interventions

Patients will receive external oblique intercostal plane block

External oblique intercostal plane block

Patients will receive thoracic paravertebral block

Thoracic paravertebral block

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-III.
  • Scheduled for open thoracotomy

You may not qualify if:

  • Patients with neurological or intellectual disability.
  • Infection at the injection site.
  • Opioid addiction.
  • Allergic reaction to local anesthetics.
  • Coagulation abnormalities.
  • Drug abuse.
  • Pregnancy.
  • Severe liver and/or renal failure.
  • Uncontrolled hypertension.
  • Severe cardiovascular problems.
  • Diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 29, 2024

Study Start

May 30, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations