Clinical trial NCT05930405: Effect of the PIEB Versus CEI on the Quality of Postoperative Recovery in Patients Undergoing VATS Lobectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video-assisted Thoracic Surgery
Keywords: Programmed intermittent epidural bolus
Continuous epidural infusion
QoR-15
Epidural anesthesia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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) \&gt; 3
6. Patients taking sedative hypnosis, anti-anxiety, and antidepressant drugs for a long time before surgery

Primary outcomes:
measure: QoR15 score at 24 hours after surgery
timeFrame: Day 1 after surgery
Secondary outcomes:
measure: QoR15 score rating at 24, 48 and 72 hours after surgery
timeFrame: 3 days after surgery
measure: QoR15 score at 48 and 72 hours after surgery
timeFrame: second and third days after surgery
measure: NRS scores at rest or during coughing at 24, 48 and 72 hours after surgery
timeFrame: 3 days after surgery
measure: Number of nighttime PCEA at 24, 48 and 72 hours after surgery
timeFrame: 3 days after surgery
measure: Total number of PCEAs at 24, 48 and 72 hours after surgery
timeFrame: 3 days after surgery
measure: Rescue analgesic drug rates after 24, 48 and 72 hours after surgery
timeFrame: 3 days after surgery
measure: Adverse event( PONV, pruritus, hypotension ) rates at 24, 48 and 72 hours after surgery
timeFrame: 3 days after surgery
measure: Local anaesthetic and opioid consumption
timeFrame: 3 days after surgery
measure: Patient satisfaction
timeFrame: 1 week after surgery
measure: Length of hospital stay
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Renchun Lai
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Renchun Lai, MD
role: PRINCIPAL_INVESTIGATOR
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