Effect of the PIEB Versus CEI on the Quality of Postoperative Recovery in Patients Undergoing VATS Lobectomy

December 16, 2025 updated by: RenChun Lai, Sun Yat-sen University

Comparative Analysis of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Recovery Quality Following Video-Assisted Thoracoscopic Surgery: A Multicenter, Prospective, Double-Blind, Randomised Controlled Trial

In recent years, lobectomy under VATS(Video-assisted thoracic surgery,VATS) has gradually emerged, but there is still a proportion of patients with postoperative pain that affects their postoperative recovery. Epidural analgesia (EA) , the gold standard for postoperative analgesia in thoracic surgery, is currently administered in two ways: 1) continuous epidural infusion 2) programmed intermittent epidural bolus. The former is currently the commonly used method of anesthetic infusion, while the latter has been better studied in obstetrics and major abdominal surgery, but is still unclear in thoracic medicine. This paper aims to investigate the impact of both drug delivery methods on the quality of postoperative recovery in patients undergoing lobectomy by VATS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent years, video-assisted thoracic surgery (VATS) has largely matured and gained widespread acceptance. Patients undergoing VATS have been reported to have less postoperative pain and a better quality of life. VATS has fewer overall post-operative complications, shorter hospital stays and lower rates of blood transfusion than conventional open surgery. However, about 38% of patients who underwent VATS were still reported to have severe postoperative pain. The placement of a thoracic drain increases the level of post-operative pain, especially when the patient breathes deeply, moves around or coughs, making the patient afraid to cooperate with deep breathing or coughing after surgery, thus increasing the chance of post-operative atelectasis and lung infection.

Epidural analgesia (EA) is the 'gold standard' for postoperative analgesia in the thoracic surgery and is an important component of multimodal analgesia in thoracic surgery. Continuous epidural infusion (CEI) of local anesthetic combined with patient-controlled analgesia (PCA) is an effective method of post-operative analgesia in thoracic surgery. However, CEI has some disadvantages, such as increased consumption of local anesthetic and limited distribution area of anesthetic, which does not suppress pain during deep breathing or coughing in the postoperative period very well, resulting in poor appetite and reduced quality of recovery. Programmed intermittent epidural bolus (PIEB) is an epidural analgesia modality that has emerged in recent years and has been more comprehensively studied in the field of postoperative analgesia in obstetrics. PIEB mode has been shown to provide better analgesia and lower consumption of local anesthetic compared to the traditional CEI mode.

The current study of PIEB in thoracic surgery under VATS is still unclear and we wanted to investigate the effect of procedural intermittent epidural bolus (PIEB) versus continuous epidural infusion (CEI) on the quality of recovery in patients undergoing lobectomy by VATS. The trial was divided into two groups, with the control group (CEI group) using a continuous epidural infusion and the trial group (PIEB group) using a programmed intermittent epidural infusion. All subjects received a standardised epidural solution containing 0.2% ropivacaine and 0.4（male）/0.3（famale）μg/ml sufentanil. The CEI group was infused continuously at a rate of 0.05*kg ml/h, while the PIEB group was programmed for intermittent infusion with 0.1*kg pumped every two hours. The PCEA is 4ml in both groups. The lockout time for both groups was 60 min. The maximum infusion dosage of the both groups is 10ml/h. Heart rate, ECG, pulse oximetry, invasive blood pressure, and end-expiratory carbon dioxide partial pressure (ETCO2) are routinely monitored on admission. Prior to induction of anaesthesia, ultrasound-assisted epidural puncture placement in the mid-thoracic segment (T5/6 or T6/7 or T7/8) is performed and the success of placement is judged using the disappearance of resistance method. The epidural catheter was placed 5 cm cephalad and 3 mL of 1.5% lidocaine was injected epidurally as a test dose to rule out inadvertent vessel entry and dural breach. This was followed by an epidural push of 10-20 mL of 0.2% ropivacaine with a test plane in the T1-T10 range. General anesthesia was induced with intravenous dexmedetomidine (0.5 ug/kg), propofol (2 mg/kg), sufentanil (0.2 ug/kg) and cis-atracurium (0.15 mg/kg). Anesthesia is maintained with 4ug/ml propofol in TCI model, with additional cis-atracurium as required, followed by additional epidural 0.2 % ropivacaine at the discretion of the anesthetist and recorded as appropriate. Vasoactive drugs may be used as appropriate to maintain blood pressure fluctuations within ±20% of basal blood pressure. The QoR15 rating scale (Quality of Recovery-15, QoR15) is one of the main methods currently used to evaluate postoperative recovery and is a valid, reliable and responsive patient-centred prognostic indicator that is highly acceptable to both patients and clinicians. Therefore, we used the 24h postoperative QoR15 score as the primary outcome.

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Renchun Lai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Proposed lobectomy under VATS under general anesthesia with tracheal intubation
  2. Agree to use epidural analgesia after surgery
  3. ASA Ⅰ- Ⅲ grade
  4. BMI 18.5-30 kg/m2
  5. Age 18-65 years old

Exclusion Criteria:

  1. Preoperative refusal of surgery due to accident or subjective
  2. Neurological dysfunction
  3. contraindications to intralesional anesthesia
  4. history of preoperative opioid use
  5. Patients with abnormal preoperative pain and pain score (NRS) > 3
  6. Patients taking sedative hypnosis, anti-anxiety, and antidepressant drugs for a long time before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: programmed intermittent epidural bolus group
All subjects received a standardised epidural solution containing 0.2% ropivacaine and 0.4（male）/0.3（famale）μg/ml sufentanil with or without PCEA (4 mL). The PIEB group is programmed for intermittent infusion with （0.1*kg）ml pumped every two hours. The lockout time for both groups is 60 min.
Procedure: programmed intermittent epidural bolus
Bolus a certain amount of liquid at fixed intervals according to a predetermined procedure
Other Names:
  • PIEB
Active Comparator: continuous epidural infusion group
All subjects received a standardised epidural solution containing 0.2% ropivacaine and 0.4（male）/0.3（famale）μg/ml sufentanil with or without PCEA (4 mL). The CEI group was infused continuously at a rate of （0.05*kg）ml/h. The lockout time for both groups was 60 min.
Procedure: continuous epidural infusion
continuous epidural infusion
Other Names:
  • CEI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoR15 score at 24 hours after surgery
Time Frame: Day 1 after surgery
QoR15 score at 24 hours after surgery
Day 1 after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of PCEAs at 24, 48 and 72 hours after surgery
Time Frame: 3 days after surgery
Total number of PCEAs at 24, 48 and 72 hours after surgery
3 days after surgery
Length of hospital stay
Time Frame: 1 month after surgery
Length of hospital stay
1 month after surgery
QoR15 score rating at 24, 48 and 72 hours after surgery
Time Frame: 3 days after surgery
QoR15 score rating at 24, 48 and 72 hours after surgery
3 days after surgery
QoR15 score at 48 and 72 hours after surgery
Time Frame: second and third days after surgery
QoR15 score at 48 and 72 hours after surgery
second and third days after surgery
NRS scores at rest or during coughing at 24, 48 and 72 hours after surgery
Time Frame: 3 days after surgery
NRS scores at rest or during coughing at 24, 48 and 72 hours after surgery
3 days after surgery
Number of nighttime PCEA at 24, 48 and 72 hours after surgery
Time Frame: 3 days after surgery
Number of nighttime PCEA at 24, 48 and 72 hours after surgery
3 days after surgery
Rescue analgesic drug rates after 24, 48 and 72 hours after surgery
Time Frame: 3 days after surgery
Rescue analgesic drug rates after 24, 48 and 72 hours after surgery
3 days after surgery
Adverse event( PONV, pruritus, hypotension ) rates at 24, 48 and 72 hours after surgery
Time Frame: 3 days after surgery
Adverse event( PONV, pruritus, hypotension ) rates at 24, 48 and 72 hours after surgery
3 days after surgery
Local anaesthetic and opioid consumption
Time Frame: 3 days after surgery
Local anaesthetic and opioid consumption
3 days after surgery
Patient satisfaction
Time Frame: 1 week after surgery
Patient satisfaction score is from 0 to 100 points. The higher scores, the more satisfaction.
1 week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Renchun Lai, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-FXY-062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Video-assisted Thoracic Surgery

Clinical Trials on programmed intermittent epidural bolus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe