Clinical trial NCT06704698: Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery
Official title: Paravertebral Block With Liposomal Bupivacaine and Epidural Block With Plane Bupivacaine for Postoperative Analgesia in Esophageal Surgery: A Randomized, Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Syndrome
Dizziness
Vomiting
Itching
Sweet Syndrome
Cold
Satisfaction, Patient
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prevention of postoperative pain is essential for the recovery of esophageal surgery. Epidural analgesia is a traditional and standard perioperative pain management for these patients. Beneficials of epidural analgesia have been widely established. However, there are still several potential disadvantages such as perioperative hypotension, failure of administration, rare but serious neurological complications. Ultrasound-guided regional nerve block has become a widely used technique due to its low degree of trauma and precise target of action. In combined with liposome bupivacaine (LB), a new long-acting local anesthetic, was proven to have a maximum duration of 72 hours, thus improving postoperative analgesia, reducing opioid consumption, and enhancing patient satisfaction. The aim of this study was to evaluate the efficacy of TPVB liposomal bupivacaine (LB) or plane bupivacaine (SB) for Overall Benefit of Analgesic Score (OBAS) after esophageal surgery.

Detailed description: After approved by the Ethics Committee of the Cancer Hospital of Zhejiang Province (Approval Number: IRB-2024-1037 (IIT)). This study was registered prior to patient admission. Written informed consent was obtained from all participants. The study is scheduled to run from November 25, 2024, to December 31, 2027. A total of 132 patients with ASA physical status I and III, undergoing thoracoscopic esophagectomy will be included. For patients in the liposomal bupivacaine group, in the left lateral decubitus position, a transversus paravertebral block (TPVB) is performed under ultrasound guidance at the right T4-T5, T7-T8, and bilateral T10-T11 paravertebral spaces, injecting 66.5mg (10 ml) liposomal bupivacaine into each space. Postoperative pain control involves patient-controlled intravenous analgesia (PCIA) with 250 μg sufentanil diluted to a total of 250 ml volume with saline. Background dose of 2-3 mL/h, PCA bolus of 2-4 mL depending on height and weight, lockout interval of 15 minutes, and a maximum dose of 10-15 mL.For the standard control group, a T6-T8 epidural block is administered, with 4-6 mL of 0.25% bupivacaine was applied depend on the height and weight. Postoperative analgesia is managed with patient-controlled epidural analgesia (PCEA), with 141 μg sufentanil and 300 mg bupivacaine hydrochloride diluted to 250 mL. Background dose of 3-6 mL/h, PCA bolus of 3-4 mL, lockout interval of 15 minutes, and a maximum dose of 20 mL.

When a participant's resting VAS score is ≥4 and they request additional pain relief, the first rescue analgesic is a single intravenous dose of acetaminophen or an NSAID (flurbiprofen axetil, 50 mg). For a second rescue, a single intravenous dose of 100 mg tramadol is administered. Additionally, the APS team adjusts the background and bolus doses based on pain relief assessments from the previous 24 hours.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist physical status I-III;
* Scheduled elective thoracoscopic esophagectomy(three-incision approach);
* Approved participation before study.

Exclusion Criteria:

* Patients with contraindications for local nerve block such as spinal anatomic structure abnormality or local infection of puncture area;
* Anergic to medications used in this study;
* Patient have chronic pain;
* Patient receiving anticoagulants, opioids or have a history of narcotic abuse or alcohol abuse;
* Inability to complete postoperative pain assessments or questionnaires due to communication barriers or mental disorders;

Primary outcomes:
measure: Overall Benefit of Analgesic Score (OBAS)
timeFrame: 3 days after surgery.
Secondary outcomes:
measure: Area under the curve of mean artery pressure (MAP < 65 mmHg)
timeFrame: From start of anesthesia to the end of surgery, an average of 5 hours.
measure: Visual Analog Scale (VAS)
timeFrame: 3 days after surgery.
measure: Total opioid consumption
timeFrame: 3 days after surgery.
measure: In-hospital stay
timeFrame: From the end of surgery to discharge of hospital. An average of 10 days.
Other outcomes:
measure: Long time Visual Analog Scale (VAS) after surgery
timeFrame: 1 year.
Locations:
city: Hangzhou
country: China
facility: Jiangling Wang
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Jiangling Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: