---
title: Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery
nct_id: NCT04056676
overall_status: UNKNOWN
phase: NA
sponsor: Mahidol University
study_type: INTERVENTIONAL
primary_condition: Breast Cancer Female
countries: Thailand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04056676.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04056676"
ct_last_update_post_date: 2021-05-24
last_seen_at: "2026-05-12T06:01:42.607Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery

**Official Title:** Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study

**NCT ID:** [NCT04056676](https://clinicaltrials.gov/study/NCT04056676)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Mahidol University
- **Conditions:** Breast Cancer Female, Pain, Postoperative
- **Start Date:** 2019-08-01
- **Completion Date:** 2022-03-01
- **CT.gov Last Update:** 2021-05-24

## Brief Summary

To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.

## Detailed Description

Regional anesthesia has been used and studied extensively in breast surgery as an opioid-sparing strategy, with block of the intercostal supply by thoracic paravertebral block (TPVB) becoming a popular technique.

This prospective randomized controlled trial is aimed to study the proper regional nerve block technique to reach the postoperative opioid-free requirement modality for breast cancer surgery.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) grade I-III
* Aged ≥ 18-80 years old
* Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection

Exclusion Criteria:

* Patient refusal
* Language barrier or inability to communicate with the operating team
* Allergy to local anesthetic
* Bleeding disorder
* Previous breast surgery or thoracic radiation therapy
* BMI ≥ 30
* Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication
* Chronic pain patient
```

## Arms

- **Intraoperative modified PEC block only** (ACTIVE_COMPARATOR) — Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon
- **Adding preoperative thoracic paravertebral nerve block** (EXPERIMENTAL) — Preoperative thoracic paravertebral nerve block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug and intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon

## Interventions

- **Thoracic paravertebral block under ultrasound guidance** (PROCEDURE) — Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
- **Intraoperative modified PEC block** (PROCEDURE) — Pectoral nerve block by surgeon under direct vision after total mastectomy
- **GA with ETT** (PROCEDURE) — General anesthesia with endotracheal intubation

## Primary Outcomes

- **Postoperative fentanyl consumption** _(time frame: at postoperative 24 hours)_ — Cumulative fentanyl consumption within postoperative 24 hours
- **Postoperative fentanyl consumption** _(time frame: at postoperative 48 hours)_ — Cumulative fentanyl consumption within postoperative 24-48 hours

## Secondary Outcomes

- **Intraoperative fentanyl use** _(time frame: Intraoperation)_
- **Postoperative pain score at rest** _(time frame: at postoperative 0 hour (PACU arrival))_
- **Postoperative pain score at rest** _(time frame: at postoperative 30 min (in PACU))_
- **Postoperative pain score at rest** _(time frame: at postoperative 1 hour (in PACU))_
- **Postoperative pain score at rest** _(time frame: Postoperative 6 hour (at ward))_
- **Postoperative pain score at rest** _(time frame: Postoperative 12 hour (at ward))_
- **Postoperative pain score at rest** _(time frame: Postoperative 18 hour (at ward))_
- **Postoperative pain score at rest** _(time frame: Postoperative 24 hour (at ward))_
- **Postoperative pain score on shoulder movement** _(time frame: Postoperative 1 hour (at PACU))_
- **Postoperative pain score on shoulder movement** _(time frame: Postoperative first day (at ward))_
- **Postoperative pain score on shoulder movement** _(time frame: Postoperative second day (at ward))_
- **First time to fentanyl requirement by IV PCA** _(time frame: Within 24 hours)_
- **Percentage of patients presenting with opioid-related adverse effects** _(time frame: Within 48 hours)_
- **Percentage of patients presenting with nerve block complications** _(time frame: Within 48 hours)_
- **Length of hospital stay** _(time frame: From preoperative admission until hospital discharge)_
- **Patient's satisfaction scale score** _(time frame: At postoperative 48 hours)_
- **Cost effectiveness analysis** _(time frame: Within 48 hours)_

## Locations (1)

- Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok Noi, Bangkok, Thailand — _RECRUITING_

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `locations.faculty of medicine siriraj hospital, mahidol university|bangkok noi|bangkok|thailand` — added _(2026-05-12)_

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