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

NCT05930405 | Completed

• 1 other identifier: 2023-FXY-062
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Video-assisted Thoracic Surgery

Keywords

Programmed intermittent epidural bolus; Continuous epidural infusion; QoR-15; Epidural anesthesia

Outcome Measures

Primary Outcomes (1)

• QoR15 score at 24 hours after surgery

  QoR15 score at 24 hours after surgery

  Day 1 after surgery

Secondary Outcomes (10)

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

  3 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

  3 days after surgery

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

  3 days after surgery

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

  3 days after surgery

Study Arms (2)

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.

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.

Procedure: continuous epidural infusion

Interventions

programmed intermittent epidural bolus PROCEDURE

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

Also known as: PIEB

programmed intermittent epidural bolus group

continuous epidural infusion PROCEDURE

continuous epidural infusion

Also known as: CEI

continuous epidural infusion group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Renchun Lai

Guangzhou, Guangdong, China

Location

Related Publications (21)

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  PMID: 31563882 RESULT

• Lee SS, Baek JH, Park SJ, Kim HJ, Kim HY, Byeon GJ. Comparison of programmed intermittent epidural bolus injection and continuous epidural injection in controlling nighttime pain and improving sleep quality after thoracotomy. Medicine (Baltimore). 2022 Nov 11;101(45):e31684. doi: 10.1097/MD.0000000000031684.

  PMID: 36397414 RESULT

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  PMID: 36109206 RESULT

Study Officials

• Renchun Lai, MD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: October 20, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)