NCT07613697

Brief Summary

Previous studies found that paravertebral and thoracic epidural continuous infusions of opioid-free local anaesthetic were found to be comparable, but paravertebral analgesia (PVA) was associated with less respiratory complications and hypotension. The newly emerging Serratus posterior superior intercostal plane block (SPSIPB) provided excellent analgesia in most studies that have focused on video-assissted thoracoscopic surgery (VATS) and breast surgery. The aim of this clinical trial is to achieve better high quality pain control with less opioid consumption either by Serratus Posterior Superior Intercostal Plane Block (SPSIPB) or Thoracic Paravertebral Block after Open thoracotomy. This study will assess and compare the analgesic efficacy of both blocks to reduce opioid consumption, the efficacy of both blocks on postoperative respiratory functions after open thoracotomy. The main question it aims to answer is: Is there a difference between Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Thoracic Paravertebral block following open thoracotomy as regard postoperative opioid consumption, postoperative pain score, and postoperative respiratory functions? All patients will take a single dose of local anesthesia either through serratus posterior superior intercostal plane block (SPSIPB) or thoracic paravertebral block and the end of open thoracotomy then total opiod consumption willbe recorded after 24 hours postoperatively.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress15%
May 2026Dec 2026

Study Start

First participant enrolled

May 15, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 22, 2026

Last Update Submit

May 28, 2026

Conditions

Keywords

Open ThoracotomySerratus Posterior Superior Intercostal Plane BlockThoracic Paravertebral Block

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

    Total first 24 hours opioid consumption

    up to 24 hours postoperative

Secondary Outcomes (5)

  • Time of the block performance

    perioperative

  • 1st time for rescue analgesia

    perioperative

  • Postoperative pain score

    2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours postoperative

  • Forced expiratory volume in 1 second (FEV1)

    baseline, 2 hours, 4 hours, 6 hours, 12, hours, 18 hours, 24 hours postoperative

  • Patient satisfaction

    24 hours postoperative

Study Arms (2)

Group S (Serratus Posterior Superior Intercostal Plane Block group)

ACTIVE COMPARATOR

patients will receive ultrasound-guided serratus posterior superior intercostal plane block

Procedure: Serratus Posterior Superior Intercostal Plane Block (single injection)

Group P (Paravertebral Block group)

ACTIVE COMPARATOR

patients will receive ultrasound guided thoracic paravertebral nerve block

Procedure: Thoracic Paravertebral block (single injection)

Interventions

As described by Tulger et al., the block will be performed by a high-frequency (7-12 MHz) linear ultrasound probe. After slight scapular lateral displacement, the probe will be placed transversely at the level of the scapular spine. The upper border of the scapula, trapezius muscle, serratus posterior superior muscle (SPSM), and 2nd and 3rd ribs will be visualized. Using in-plane technique, the 80 mm block needle will be introduced from the level of the 3rd rib in the caudocranial direction through the medial scapular border passes through the skin and subcutaneous tissue to target the 3rd rib. After negative aspiration, the needle tip will be placed between the 3rd rib and the SPSM, hydro-dissection using 1-2 ml saline to ensure the correct needle placement then 30 ml of 0.25% bupivacaine will be injected between the SPSM and the 3rd rib.

Group S (Serratus Posterior Superior Intercostal Plane Block group)

A high-frequency (7-12 MHz) linear ultrasound probe will be placed 2-3cm lateral to the upper edge of the spinous process of the 5th thoracic vertebrae body which identified by counting down from the seventh cervical vertebrae. After visualizing the transverse process, the underlying muscles, the paravertebral space, the internal intercostal membrane, and the pleura, 80 mm block needle will be inroduced by the in-plane technique till the paravertebral space over the superior border of the transverse process. After identification of the paravertebral space using a loss of resistance technique, 30 ml of 0.25% bupivacaine will be injected.

Group P (Paravertebral Block group)

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI (25-35kg/m²).
  • Physical status: ASA I-II - III.
  • Patients undergoing posterolateral thoracotomy for lung resection.

You may not qualify if:

  • Emergency surgeries.
  • Uncooperative patient.
  • History of allergy to study drugs.
  • Patients with coagulation disorders, advanced hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders (e.g. Alzheimer, Dementia, Delirium, mental retardation and cognitive dysfunction).
  • Infection at the site of block .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig university hospitals

Zagazig, Sharqia Province, Egypt

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

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 GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations