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Pain SyndromeNCT06704698

Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery

A study testing Liposomal bupivacaine and Bupivacaine Hydrochloride in people with Pain Syndrome and Dizziness, run by Zhejiang Cancer Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pain Syndrome, Dizziness, Vomiting
What is being tested?
Liposomal bupivacaine and Bupivacaine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteChina
Study dates
3 Dec 2024to 13 Mar 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologist physical status I-III;
  • Scheduled for elective minimally invasive esophagectomy
  • Approved participation before study.

Who cannot join

  • 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 disorders, chronic opioid use, or a history of anesthetic drug of alcohol abuse;
  • hepatic impairement (Child-Pugh class B and higher) or renal impairement (serum creatinine > 133mg/L);
  • Inability to complete postoperative pain assessments or questionnaires due to communication barriers or mental disorders;
  • participation in another clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Jiangling Wang

    Hangzhou, Zhejiang, 310022

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Liposomal bupivacaine, Bupivacaine Hydrochloride
Medical subject headings
Somatoform Disorders, Dizziness, Vomiting, Pruritus, Sweet Syndrome, Common Cold, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal bupivacaineDrug

    Also called LB

    Thoracic paravertebral block with liposomal bupivacaine.

  • Bupivacaine HydrochlorideDrug

    Also called PB (Plane Bupivacaine)

    Epidural block with plane bupivacaine.

Study groups in NCT06704698
Study groupRoleWhat they receive
Thoracic paravertebral blockExperimentalUltrasound guided paravertebral block (TPVB) with liposomal bupivacaine is performed in this group. 40ml of liposomal bupivacaine and saline mixture was injected to the right T4-T5, T7-T8, and bilateral T10-T11 paravertebral spaces, with 10 ml for each space. Patient-controlled intravenous analgesia (PCIA) is used for postoperative pain management.
Receives: Drug: Liposomal bupivacaine
Epidural blockOtherFor the standard control group, a T6-T8 epidural block is administered. Postoperative analgesia is managed with patient-controlled epidural analgesia (PCEA).
Receives: Drug: Bupivacaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Benefit of Analgesic Score (OBAS)

    Record pain, dizziness,vomiting, itching, sweating, feeling cold, and analgesic satisfaction in the first 72 hours. The higher scores mean a worse outcome.

    Measured: 3 days after surgery.

Secondary outcomes (4)
  1. Area under the curve of mean artery pressure (MAP < 65 mmHg)

    Measure the area under the curve of mean artery pressure.

    Measured: From start of anesthesia to the end of surgery, an average of 5 hours.

  2. Visual Analog Scale (VAS)

    Record Visual Analog Scale scores after surgery, the scale of scores is from 0 to 10 and higher scores mean a worse outcome.

    Measured: 3 days after surgery.

  3. Total opioid consumption

    Record total opioid consumption after surgery.

    Measured: 3 days after surgery.

  4. In-hospital stay

    Record in-hospital stay after surgery.

    Measured: From the end of surgery to discharge of hospital. An average of 10 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start3 Dec 2024
  3. Primary completion13 Mar 2025
  4. Study completion13 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06704698
Sponsor's protocol ID
IRB-2024-1037(IIT)
Status last verified
Oct 2026
First submitted
18 Nov 2024
Last updated
15 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study plan is available when required to the principal investigator.

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