NCT06838039

Brief Summary

Title: Assessing the Impact of Additional Serratus Anterior Block on Postoperative Pain After Rhomboid Intercostal Block in VATS Patients Purpose: This randomized controlled trial aims to evaluate whether the addition of a Serratus Anterior Plane Block (SAPB) to the standard Rhomboid Intercostal Block (RIB) improves postoperative pain management in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS). Study Design:

  • Type: Randomized Controlled Trial (RCT)
  • Participants: 50 patients aged 18 -70 requiring VATS, randomized into two groups: one receiving RIB alone, and the other receiving RIB + SAPB.
  • Duration: Pain and opioid consumption will be measured within 48 hours post-surgery.
  • Outcome Measures: Pain levels using the Visual Analog Scale (VAS), opioid usage, and patient satisfaction. Significance: The study addresses the gap in research regarding the combined use of SAPB and RIB in pain control for VATS. It hypothesizes that the combination will lead to better pain relief and reduced opioid dependence compared to RIB alone.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress66%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

January 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

January 20, 2025

Last Update Submit

August 22, 2025

Conditions

Keywords

Postoperative Pain ManagementVideo-Assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

    Postoperative pain will be assessed using the Visual Analog Scale for pain which higher score mean more pain at various time intervals (e.g., 1,12, 24, 36 and 48 hours post-surgery).

    48 hours post-surgery.

Secondary Outcomes (1)

  • Opioid Consumption

    48 hours post-surgery.

Study Arms (2)

Arm 1 (RIB Only)

EXPERIMENTAL

Participants receive a Rhomboid Intercostal Block (RIB) as the sole regional anesthesia technique for postoperative pain management after VATS

Procedure: Rhomboid Intercostal Block (RIB)

Arm 2 (RIB + SAPB)

EXPERIMENTAL

Participants receive both RIB and SAPB within 24 hours postoperatively

Procedure: Rhomboid Intercostal Block (RIB) + Serratus Anterior Plane Block (SAPB)

Interventions

A combination of two regional anesthesia techniques, Rhomboid Intercostal Block (RIB) and Serratus Anterior Plane Block (SAPB),(THE SAPB will received within 24 hours after RIB) administered under ultrasound guidance. SAPB targets the lateral cutaneous branches of the thoracic nerves, complementing the pain relief provided by RIB. This combination is used in Arm 2 to enhance postoperative analgesia.

Arm 2 (RIB + SAPB)

Rhomboid Intercostal Block (RIB) A regional anesthesia technique administered under ultrasound guidance for postoperative pain relief. This will be used as the sole intervention in Arm 1.

Arm 1 (RIB Only)

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18-70 years.
  • Patients undergoing Video-Assisted Thoracoscopic Surgery (VATS).
  • Classified as ASA physical status I-III (low to moderate surgical risk).
  • Ability to provide informed consent and follow study protocols.

You may not qualify if:

  • Known allergy or hypersensitivity to local anesthetics.
  • Presence of bleeding disorders or anticoagulant use.
  • History of chronic opioid use or opioid dependence.
  • Anatomical abnormalities or conditions preventing the application of regional anesthesia (e.g., chest wall deformities).
  • Presence of neurological disorders affecting pain perception.
  • Cognitive impairments, language barriers, or inability to communicate effectively.
  • Pregnancy or breastfeeding.
  • Refusal or inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Ahli hospital

Hebron, Palestinian Territories

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Mohammed Adel Adwan, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

February 20, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations