---
title: Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
nct_id: NCT02204878
overall_status: UNKNOWN
phase: PHASE4
sponsor: Peking Union Medical College Hospital
study_type: INTERVENTIONAL
primary_condition: Hepatic Hemangioma Located in the Right Liver
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02204878.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02204878"
ct_last_update_post_date: 2014-07-30
last_seen_at: "2026-05-12T07:33:55.484Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

**Official Title:** A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

**NCT ID:** [NCT02204878](https://clinicaltrials.gov/study/NCT02204878)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Peking Union Medical College Hospital
- **Conditions:** Hepatic Hemangioma Located in the Right Liver, Laparotomy Surgery
- **Start Date:** 2014-07
- **CT.gov Last Update:** 2014-07-30

## Brief Summary

To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age between 20-70 years old;
* Hepatic hemangioma patients who will undergo laparotomy surgery: diameter of hepatic hemangioma between 5-15cm, located in the right liver;
* Child score 5-6;
* BMI: 19-25;
* ASA: Ⅰ \~ Ⅱ grade;
* No comorbidities such as diabetes, hypertension, cardio renal or respiratory dysfunction, mental illness;
* No known allergies;
* No participation in other clinical trials within 2 months;
* Have been informed consent.
* Surgery-related: right subcostal incision, surgical time\< 4 hours, hepatic pedicle occlusion time\< 20 minutes, bleeding\< 1000ml, no blood transfusions.

Exclusion Criteria:

* History of chronic pain，long-term use of analgesic drugs or alcohol abuse;
* Allergic to NSAIDs, opioids or sulfa drugs;
* Coagulopathy or other hematological disorder；
* Active peptic ulcer, gastrointestinal bleeding, inflammatory bowel disease;
* Pregnant or lactating;
* Mentally unstable to use PCA;
* Preoperative pain caused by other disease;
* Analgesic drugs or NSAIDs intake one week before surgery;
* Preoperative systemic inflammatory response syndrome;
* Preoperative chemotherapy or radiotherapy;
* Preoperative or postoperative use of steroids;
* Operative time\> 4 hours, hepatic pedicle occlusion time\> 20 minutes, blood loss\> 1000ml, or intraoperative blood transfusion;
* TBil\> 34 umol/L、PT prolongation\> 3S、ALB\< 30 g/L、or Child score\> 7 within 42 hours after surgery；
* Bleeding、biliary fistula, intra-abdominal infections or other postoperative complications.
```

## Arms

- **A** (PLACEBO_COMPARATOR) — 1ml of saline was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. 1ml saline Q12h will be given within 72 hours after surgery
- **AT** (EXPERIMENTAL) — Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery

## Interventions

- **Parecoxib Sodium** (DRUG) — Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery

## Primary Outcomes

- **VAS scores change** _(time frame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery)_

## Secondary Outcomes

- **liver function change** _(time frame: befor and 42hrs and 66hrs after surgery)_
- **kidney function change** _(time frame: befor and 42hrs and 66hrs after surgery)_
- **blood ammonia level change** _(time frame: before and 42hrs, 66hrs after surgery)_

## Locations (1)

- Peking union medical college hospital, Beijing, Beijing Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — 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)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.peking union medical college hospital|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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