Clinical trial NCT04962152: Naldebain and Video-assisted Thoracoscopic Surgery
Official title: To Explore the Effects of Naldebain Combined With Thoracic Paravertebral Block in Video-assisted Thoracoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Analgesia
Nausea and Vomiting, Postoperative
Itching
Injection Site Reaction
Satisfaction, Patient
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the postoperative analgesic effect of combined use of Naldebain® and thoracic paravertebral block in thoracoscopic surgery

Detailed description: Video-assisted thoracoscopic surgery (VATS) can be associated with stronger postoperative pain than is commonly believed. Pain control after thoracic surgery is important because increased acute pain has been shown to increase the incidence of chronic pain, and untreated pain may lead to increased morbidity. It is generally accepted to introduce multimodal analgesic strategies based on regional blockade, opioids and non-steroidal anti-inflammatory drugs.

Paravertebral block (PVB) involves the injection of local anesthetic into a wedge-shaped space lateral to the spinal nerves as they emerge from intervertebral foramina. It produces ipsilateral somatosensory and sympathetic nerve blockade effective for anesthesia as well as for management of pain of unilateral origin from the chest and abdomen. So far, thoracic paravertebral block (TPVB) is the most common technique used for patients undergoing VATS. TPVB may be useful after VATS because a single injection of local anesthesia may provide effective analgesia for the intense short-duration pain that patients experience.

Nalbuphine sebacate (Naldebain®) is a long-acting prodrug of nalbuphine developed for meeting the unmet medical need of long-acting analgesics. It is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. The currently proposed clinical use of nalbuphine sebacate is a single dose of Naldebain® administered intramuscularly approximately 24 h prior to the planned surgery for pain relief.

The purpose of this study is to determine the safety and efficacy of TPVB combined with a single dose of intramuscular Naldebain® administered preoperatively to patients scheduled to undergo VATS.

Eligibility criteria: Inclusion Criteria:

* 1) Subject's age: 20\~65 years old
* 2) American Society of Anesthesiologists (ASA) Physical Status classification: I\~III
* 3) Patients who need postoperative pain relief due to thoracoscopic surgery

Exclusion Criteria:

* 1. The patient suffers from a communication disorder
* 2. The patient has coagulopathy
* 3. Sick with obvious heart, lung, liver or kidney disease
* 4. The patient's body mass index is less than 18.5 or greater than 35
* 5. Pregnant patients
* 6. Patients who took opioids for more than three weeks before surgery
* 7. Patients with contraindications to local anesthesia
* 8. Patients with a history of chronic pain
* 9. Patients with a history of drug allergy to Naldebain

Primary outcomes:
measure: postoperative analgesic effect
timeFrame: During the first one hour in the recovery room, the pain intensity was evaluated every 15 minutes.
measure: postoperative analgesic effect
timeFrame: the pain intensity was evaluated at 3 hours after surgery.
measure: postoperative analgesic effect
timeFrame: the pain intensity was evaluated at 6 hours after surgery.
measure: postoperative analgesic effect
timeFrame: the pain intensity was evaluated at 12 hours after surgery.
measure: postoperative analgesic effect
timeFrame: the pain intensity was evaluated at 24 hours after surgery.
measure: postoperative analgesic effect
timeFrame: the pain intensity was evaluated at 36 hours after surgery.
measure: postoperative analgesic effect
timeFrame: the pain intensity was evaluated at 48 hours after surgery.
measure: postoperative analgesic effect
timeFrame: the pain intensity was evaluated at 72 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Department of Anesthesiology, Kaohsiung Medical University Hospital
Study officials:
affiliation: Department of anesthesiology, Kaohsiung Medical University Hospital
name: Hung-Te Hsu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: