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Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery

Paravertebral Block With Liposomal Bupivacaine and Epidural Block With Plane Bupivacaine for Postoperative Analgesia in Esophageal Surgery: A Randomized, Non-inferiority Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06704698
Enrollment
132
Registered
2024-11-26
Start date
2024-12-03
Completion date
2025-12-30
Last updated
2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cold, Dizziness, Itching, Pain Syndrome, Satisfaction, Patient, Sweet Syndrome, Vomiting

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.

Interventions

DRUGLiposomal bupivacaine

Thoracic paravertebral block with liposomal bupivacaine.

DRUGBupivacaine Hydrochloride

Epidural block with plane bupivacaine.

Sponsors

Zhejiang Cancer Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Overall Benefit of Analgesic Score (OBAS)3 days after surgery.Record pain, dizziness,vomiting, itching, sweating, feeling cold, and analgesic satisfaction in the first 72 hours. The higher scores mean a worse outcome.

Secondary

MeasureTime frameDescription
Area under the curve of mean artery pressure (MAP < 65 mmHg)From start of anesthesia to the end of surgery, an average of 5 hours.Measure the area under the curve of mean artery pressure.
Visual Analog Scale (VAS)3 days after surgery.Record Visual Analog Scale scores after surgery, the scale of scores is from 0 to 10 and higher scores mean a worse outcome.
Total opioid consumption3 days after surgery.Record total opioid consumption after surgery.
In-hospital stayFrom the end of surgery to discharge of hospital. An average of 10 days.Record in-hospital stay after surgery.

Other

MeasureTime frameDescription
Long time Visual Analog Scale (VAS) after surgery1 year.Record 3 months and 12 months Visual Analog Scale Scores after surgery, the scale of scores is from 0 to 10 and higher scores mean a worse outcome.

Countries

China

Contacts

Primary ContactJiangling Wang, M.D
wangjl@zjcc.org.cn+8615168373331

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026