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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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.
- Conditions
- Video-assisted Thoracic Surgery
- 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 group | Role | What they receive |
|---|---|---|
| programmed intermittent epidural bolus group | Experimental | 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. Receives: Procedure: programmed intermittent epidural bolus |
| continuous epidural infusion group | Active comparator | 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. Receives: Procedure: continuous epidural infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR15 score at 24 hours after surgery
QoR15 score at 24 hours after surgery
Measured: Day 1 after surgery
Secondary outcomes (10)
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
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
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
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
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
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
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
Local anaesthetic and opioid consumption
Local anaesthetic and opioid consumption
Measured: 3 days after surgery
Patient satisfaction
Patient satisfaction score is from 0 to 100 points. The higher scores, the more satisfaction.
Measured: 1 week after surgery
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.
- First posted5 Jul 2023
- Study start20 Oct 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Video-assisted Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RenChun Lai, Sun Yat-sen University
- Investigators
- Renchun Lai, MD, Principal investigator, Sun Yat-Sen University Cancer Center
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 27160473Bertolaccini 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 36672359Rauma 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 31202692Ng 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 17251209Yegin 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 12965314Amr 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 20103303Bishop 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 31903338Ueda 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 15983464George 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 23223119Hussain 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 32703549Wydall 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 36720838Capogna 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 21788309Leone 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 26431778Hogan 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 11915061Cole 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05930405
- Acronym / sponsor ID
- 2023-FXY-062
- Conditions
- Video-assisted Thoracic Surgery
- Keywords
- Programmed intermittent epidural bolus, Continuous epidural infusion, QoR-15, Epidural anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| programmed intermittent epidural bolus group | Experimental | Procedure: programmed intermittent epidural bolusAll 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. |
| continuous epidural infusion group | Active comparator | Procedure: continuous epidural infusionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| programmed intermittent epidural bolusAlso: PIEBBolus a certain amount of liquid at fixed intervals according to a predetermined procedure | Procedure or surgery | programmed intermittent epidural bolus group |
| continuous epidural infusionAlso: CEIcontinuous epidural infusion | Procedure or surgery | continuous epidural infusion group |
Primary outcome
QoR15 score at 24 hours after surgery
Time frame: Day 1 after surgery
QoR15 score at 24 hours after surgery
10 secondary outcomes
QoR15 score rating at 24, 48 and 72 hours after surgery
Time frame: 3 days after surgery
QoR15 score at 48 and 72 hours after surgery
Time frame: 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
Number of nighttime PCEA 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
Time frame: 3 days after surgery
Rescue analgesic drug rates after 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
Time frame: 3 days after surgery
Local anaesthetic and opioid consumption
Time frame: 3 days after surgery
Patient satisfaction
Time frame: 1 week after surgery
Length of hospital stay
Time frame: 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Results publication: PubMed 27160473Bendixen 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.
- Results publication: PubMed 36672359Bertolaccini 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.
- Results publication: PubMed 31202692Rauma 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.
- Results publication: PubMed 17251209Ng 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.
- Results publication: PubMed 12965314Yegin 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.
- Results publication: PubMed 20103303Amr 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.
- Results publication: PubMed 31903338Bishop 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.
- Results publication: PubMed 15983464Ueda 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.
- Results publication: PubMed 23223119George 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.
- Results publication: PubMed 32703549Hussain 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.
- Results publication: PubMed 36720838Wydall 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.
- Results publication: PubMed 21788309Capogna 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.
- Individual participant dataSharing planned: No
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Postoperative Pain, Thoracic Surgery
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Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Active, not recruitingObservational study
Anesthesia Management, Inflammatory Response and Recovery After Non-intubated VATS Pericardial Window
Pericardial Effusion, Inflammatory Response After Surgery
Recruiting
Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery
Postoperative Pain, Thoracic Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renchun Lai, MD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.