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Video-assisted Thoracic SurgeryNCT05930405

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

A study testing programmed intermittent epidural bolus and continuous epidural infusion in people with Video-assisted Thoracic Surgery, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Video-assisted Thoracic Surgery
What is being tested?
programmed intermittent epidural bolus and continuous epidural infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteChina
Study dates
20 Oct 2023to 30 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Renchun Lai

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
programmed intermittent epidural bolus, continuous epidural infusion
Keywords
Programmed intermittent epidural bolus, Continuous epidural infusion, QoR-15, Epidural anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • programmed intermittent epidural bolusProcedure or surgery

    Also called PIEB

    Bolus a certain amount of liquid at fixed intervals according to a predetermined procedure

  • continuous epidural infusionProcedure or surgery

    Also called CEI

    continuous epidural infusion

Study groups in NCT05930405
Study groupRoleWhat they receive
programmed intermittent epidural bolus groupExperimentalAll 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.
Receives: Procedure: programmed intermittent epidural bolus
continuous epidural infusion groupActive comparatorAll 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.
Receives: Procedure: continuous epidural infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QoR15 score at 24 hours after surgery

    QoR15 score at 24 hours after surgery

    Measured: Day 1 after surgery

Secondary outcomes (10)
  1. QoR15 score rating at 24, 48 and 72 hours after surgery

    QoR15 score rating at 24, 48 and 72 hours after surgery

    Measured: 3 days after surgery

  2. QoR15 score at 48 and 72 hours after surgery

    QoR15 score at 48 and 72 hours after surgery

    Measured: second and third days after surgery

  3. NRS scores at rest or during coughing at 24, 48 and 72 hours after surgery

    NRS scores at rest or during coughing at 24, 48 and 72 hours after surgery

    Measured: 3 days after surgery

  4. Number of nighttime PCEA at 24, 48 and 72 hours after surgery

    Number of nighttime PCEA at 24, 48 and 72 hours after surgery

    Measured: 3 days after surgery

  5. Total number of PCEAs at 24, 48 and 72 hours after surgery

    Total number of PCEAs at 24, 48 and 72 hours after surgery

    Measured: 3 days after surgery

  6. Rescue analgesic drug rates after 24, 48 and 72 hours after surgery

    Rescue analgesic drug rates after 24, 48 and 72 hours after surgery

    Measured: 3 days after surgery

  7. Adverse event( PONV, pruritus, hypotension ) rates at 24, 48 and 72 hours after surgery

    Adverse event( PONV, pruritus, hypotension ) rates at 24, 48 and 72 hours after surgery

    Measured: 3 days after surgery

  8. Local anaesthetic and opioid consumption

    Local anaesthetic and opioid consumption

    Measured: 3 days after surgery

  9. Patient satisfaction

    Patient satisfaction score is from 0 to 100 points. The higher scores, the more satisfaction.

    Measured: 1 week after surgery

  10. Length of hospital stay

    Length of hospital stay

    Measured: 1 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2023
  2. Study start20 Oct 2023
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05930405
Sponsor's protocol ID
2023-FXY-062
Status last verified
Dec 2025
First submitted
26 Jun 2023
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bendixen M, Jorgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.

    PubMed 27160473
  • Bertolaccini L, Fornaro G, Ciani O, Prisciandaro E, Crisci R, Tarricone R, Spaggiari L; VATS Group. The Impact of Surgical Experience in VATS Lobectomy on Conversion and Patient Quality of Life: Results from a Comprehensive National Video-Assisted Thoracic Surgical Database. Cancers (Basel). 2023 Jan 8;15(2):410. doi: 10.3390/cancers15020410.

    PubMed 36672359
  • Rauma V, Andersson S, Robinson EM, Rasanen JV, Sintonen H, Salo JA, Ilonen IK. Thoracotomy and VATS Surgery in Local Non-Small-Cell Lung Cancer: Differences in Long-Term Health-Related Quality Of Life. Clin Lung Cancer. 2019 Sep;20(5):378-383. doi: 10.1016/j.cllc.2019.05.010. Epub 2019 May 16.

    PubMed 31202692
  • Ng A, Swanevelder J. Pain relief after thoracotomy: is epidural analgesia the optimal technique? Br J Anaesth. 2007 Feb;98(2):159-62. doi: 10.1093/bja/ael360. No abstract available.

    PubMed 17251209
  • Yegin A, Erdogan A, Kayacan N, Karsli B. Early postoperative pain management after thoracic surgery; pre- and postoperative versus postoperative epidural analgesia: a randomised study. Eur J Cardiothorac Surg. 2003 Sep;24(3):420-4. doi: 10.1016/s1010-7940(03)00345-2.

    PubMed 12965314
  • Amr YM, Yousef AA, Alzeftawy AE, Messbah WI, Saber AM. Effect of preincisional epidural fentanyl and bupivacaine on postthoracotomy pain and pulmonary function. Ann Thorac Surg. 2010 Feb;89(2):381-5. doi: 10.1016/j.athoracsur.2009.10.060.

    PubMed 20103303
  • Bishop B, Pearce B, Willshire L, Kilpin M, Howard W, Weinberg L, Tan C. High Frequency, Low Background Rate Extrapleural Programmed Intermittent Bolus Ropivacaine Provides Superior Analgesia Compared with Continuous Infusion for Acute Pain Management Following Thoracic Surgery: A Retrospective Cohort Study. Anesth Pain Med. 2019 Oct 9;9(5):e97052. doi: 10.5812/aapm.97052. eCollection 2019 Oct.

    PubMed 31903338
  • Ueda K, Ueda W, Manabe M. A comparative study of sequential epidural bolus technique and continuous epidural infusion. Anesthesiology. 2005 Jul;103(1):126-9. doi: 10.1097/00000542-200507000-00019.

    PubMed 15983464
  • George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.

    PubMed 23223119
  • Hussain N, Lagnese CM, Hayes B, Kumar N, Weaver TE, Essandoh MK, Reno J, Small RH, Abdallah FW. Comparative analgesic efficacy and safety of intermittent local anaesthetic epidural bolus for labour: a systematic review and meta-analysis. Br J Anaesth. 2020 Oct;125(4):560-579. doi: 10.1016/j.bja.2020.05.060. Epub 2020 Jul 21.

    PubMed 32703549
  • Wydall S, Zolger D, Owolabi A, Nzekwu B, Onwochei D, Desai N. Comparison of different delivery modalities of epidural analgesia and intravenous analgesia in labour: a systematic review and network meta-analysis. Can J Anaesth. 2023 Mar;70(3):406-442. doi: 10.1007/s12630-022-02389-9. Epub 2023 Jan 31.

    PubMed 36720838
  • Capogna G, Camorcia M, Stirparo S, Farcomeni A. Programmed intermittent epidural bolus versus continuous epidural infusion for labor analgesia: the effects on maternal motor function and labor outcome. A randomized double-blind study in nulliparous women. Anesth Analg. 2011 Oct;113(4):826-31. doi: 10.1213/ANE.0b013e31822827b8. Epub 2011 Jul 25.

    PubMed 21788309
  • Leone Roberti Maggiore U, Silanos R, Carlevaro S, Gratarola A, Venturini PL, Ferrero S, Pelosi P. Programmed intermittent epidural bolus versus continuous epidural infusion for pain relief during termination of pregnancy: a prospective, double-blind, randomized trial. Int J Obstet Anesth. 2016 Feb;25:37-44. doi: 10.1016/j.ijoa.2015.08.014. Epub 2015 Oct 1.

    PubMed 26431778
  • Hogan Q. Distribution of solution in the epidural space: examination by cryomicrotome section. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):150-6. doi: 10.1053/rapm.2002.29748.

    PubMed 11915061
  • Cole J, Hughey S. Bolus epidural infusion improves spread compared with continuous infusion in a cadaveric porcine spine model. Reg Anesth Pain Med. 2019 Sep 27:rapm-2019-100818. doi: 10.1136/rapm-2019-100818. Online ahead of print.

    PubMed 31563882

Questions about this trial

What is this clinical trial studying?

A study testing programmed intermittent epidural bolus and continuous epidural infusion in people with Video-assisted Thoracic Surgery, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QoR15 score at 24 hours after surgery (time frame: Day 1 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05930405, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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