Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologist physical status I-III;
Scheduled elective thoracoscopic esophagectomy(three-incision approach);
Approved participation before study.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Liposomal bupivacaine
DrugThoracic paravertebral block with liposomal bupivacaine.
Bupivacaine Hydrochloride
DrugEpidural block with plane bupivacaine.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Thoracic paravertebral blockExperimental treatment 1 intervention
Group B: Epidural blockOther 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
3 days after surgery.Secondary outcomes
1
Area under the curve of mean artery pressure (MAP < 65 mmHg)
Measure the area under the curve of mean artery pressure.
Time frame
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.
Time frame
3 days after surgery.3
Total opioid consumption
Record total opioid consumption after surgery.
Time frame
3 days after surgery.4
In-hospital stay
Record in-hospital stay after surgery.
Time frame
From the end of surgery to discharge of hospital. An average of 10 days.Other outcomes
1
Long time Visual Analog Scale (VAS) after surgery
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.
Time frame
1 year.Sponsors and contacts
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Source ClinicalTrials.gov