Thoracic Paravertebral Block for Postoperative Pain Management After VATS

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: 0.4 ml/kg of 0.5% bupivacaine

• Registration Number: NCT06689358
• Lead Sponsor: King Hussein Cancer Center

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).

Detailed Description

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). Adult patients scheduled for elective VATS who meet the eligibility criteria will be randomized to either Arm:

Arm 1: General anesthesia with TPVB;

Arm 2: General anesthesia alone (control group).

Primary Outcome: to assess Opioid requirement in the PACU

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia with TPVB	0.4 ml/kg of 0.5% bupivacaine	0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space

Primary Outcome Measures

Name	Time	Method
Opioid requirement in the PACU	Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)	Opioid requirement in the PACU, recorded as "yes" or "no."

Secondary Outcome Measures

Name	Time	Method
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)	Pain intensity measured by Numeric Rating Scale- NRS at several time points, Range: 0 (no pain) to 10 (worst imaginable pain), Interpretation: Higher scores indicate worse pain intensity

Trial Locations

Locations (1)

King Hussein Cancer Center; 🇯🇴 Amman, Jordan