Thoracic Paravertebral Block for Postoperative Pain Management After VATS

NCT06689358 | Completed

• 1 other identifier: 22 KHCC 158
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS).

Conditions

Pain, Postoperative

Keywords

Opioids, Pain Management,; Thoracic Paravertebral Block. VATS; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Opioid requirement in the PACU

  Opioid requirement in the PACU, recorded as "yes" or "no."

  Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)

Secondary Outcomes (1)

• Pain intensity measured by Numeric Rating Scale -NRS

  Pain intensity measured using the Numeric Rating Scale (NRS) at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)

Study Arms (2)

General anesthesia with TPVB

EXPERIMENTAL

0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space

Drug: 0.4 ml/kg of 0.5% bupivacaine

General anesthesia alone (control group).

NO INTERVENTION

General anesthesia SOC alone

Interventions

0.4 ml/kg of 0.5% bupivacaine DRUG

0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space

General anesthesia with TPVB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients scheduled for elective VATS, ASA physical status II-III, BMI 19-40.

You may not qualify if:

• Patient refusal, coagulation disorders, contraindications to TPVB, chronic analgesic use, mental illness

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, 11941, Jordan

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ahed Al-Edwan, MD

  KHCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: General anesthesia with TPVB; Type: Experimental Intervention: 0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space. Arm 2: General anesthesia alone (control group). Type: No intervention (control) Intervention: No intervention

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 14, 2024
• Study Start: November 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)