Effect of the PIEB Versus CEI on the Quality of Postoperative Recovery in Patients Undergoing VATS Lobectomy
NCT ID: NCT05930405
Last Updated: 2025-12-17
Study Results
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Basic Information
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COMPLETED
NA
252 participants
INTERVENTIONAL
2023-10-20
2024-10-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
programmed intermittent epidural bolus
Bolus a certain amount of liquid at fixed intervals according to a predetermined procedure
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.
continuous epidural infusion
continuous epidural infusion
Interventions
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programmed intermittent epidural bolus
Bolus a certain amount of liquid at fixed intervals according to a predetermined procedure
continuous epidural infusion
continuous epidural infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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RenChun Lai
Clinical Professor
Principal Investigators
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Renchun Lai, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Renchun Lai
Guangzhou, Guangdong, China
Countries
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References
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Other Identifiers
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2023-FXY-062
Identifier Type: -
Identifier Source: org_study_id