NCT07572019

Brief Summary

The primary aim: is to compare the effect of US guided ESP block at two levels versus intracavitary blockade in medical thoracoscopy on total peri-procedural (intraoperative and post-operative 12 hours) nalbuphine consumption (mg) during medical thoracoscopy. Secondary aims: Time to first rescue analgesia, postoperative VAS, haemodynamics, recovery time (Aldert \> 9), and adverse events

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
2mo left

Started May 2026

Shorter than P25 for phase_2

Status
not yet 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

First Submitted

Initial submission to the registry

April 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary aim: is to compare the effect of US guided ESP block at two levels versus intracavitary blockade in medical thoracoscopy on total peri procedural nalbuphine (mg) consumption during medical thoracoscopy

    intraoperative and post-operative 12 hours

Study Arms (2)

50 patients will receive two levels of ultrasound-guided erector spinae plane block (ESPB) at T5 an

ACTIVE COMPARATOR
Procedure: ultrasound-guided erector spinae plane block in medical pleuroscopy

patients will receive intracavitary anaesthesia ICA with total volume 40 ml, 20 ml of 0.25% bu

ACTIVE COMPARATOR
Procedure: Intracavitary anaesthesia ICA

Interventions

On the lateral decubitus position, under full aseptic technique; a high frequency (5-13 MHz) linear probe (or curvilinear in obese patients) of ultrasound covered sterilely will be placed in a parasagittal longitudinal orientation approximately 3 cm lateral to the spinous process to identify the trapezius, rhomboid major (if present), erector spinae muscle and thehyperechoic transverse process with its acoustic shadow, with the target being the fascial plane deep to the erector spinae muscle and superficial to the transverse process; the needle will be inserted in-plane in a cranial-to-caudal direction under real-time ultrasound guidance until it contacts the transverse process, after which 1-3 ml of normal saline is injected to confirm correct plane by lifting the erector spinae muscle off the transverse process, then following negative aspiration 20 ml of 0.25% bupivacaine at each level (10 ml 0.5% bupivacaine + 10 ml normal saline ) will be injected incrementally

50 patients will receive two levels of ultrasound-guided erector spinae plane block (ESPB) at T5 an

After skin infiltration with lidocaine 2%, at the entry point of the trocar, small (2-4 cm) skin incision in the chest wall will be done, A trocar will be introduced into the pleural cavity. If necessary, air is introduced to allow the lung to collapse, creating space to view the pleural surface. The thoracoscope will be inserted to visualize the pleura. The interventional pulmonologist will receive the pre-prepared syringe from the block anaesthetist and will administer the solution intracavitarily via the thoracoscope working channel, without knowledge of its contents. In both groups, a total volume of 40 mL of solution is administered: 20 mL is sprayed over the costal, diaphragmatic, and mediastinal pleura via the thoracoscope working channel, and an additional 20 mL is injected through the chest tube inserted at the end of the procedure , 10-mL normal saline flush, and the chest tube is then clamped for 5 minutes

patients will receive intracavitary anaesthesia ICA with total volume 40 ml, 20 ml of 0.25% bu

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients belonging to American Society of Anesthesiologists (ASA) I-III scheduled for medical thoracoscopy under adequate sedation and analgesia.

You may not qualify if:

  • Patients will be excluded if; history of allergy or contraindication to any of the studied drugs, BMI more than 35 kg/m2, chronic opioid use or abuse, patients for whom ESPB block is contraindicated (patient refusal, coagulation disorder, skin infection at the injection site), history of post-thoracotomy, chest wall deformity, severe uncontrolled comorbidity, intubated patients, or if the interventional physician wants general anaesthesia from the start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Donia Hany Hany, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and surgical ICU

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 7, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share