The efficacy of rhomboid intercostal block for pain management after video-assisted thoracoscopic surgery: a prospective, randomized-controlled trial.
Bahadir Ciftci, Selcuk Alver, Hande Güngör...
https://pubmed.ncbi.nlm.nih.gov/38668898Actively Recruiting
Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID07441902
Ultrasound-Guided Liposomal Bupivacaine Plus Bupivacaine Rhomboid Intercostal Block for Postoperative Pain Relief in Patients Undergoing Thoracoscopic Surgery: A Multi-Center Randomized Controlled Trial
Led by Beijing Tiantan Hospital · Updated on 2026-03-06
134
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of liposomal bupivacaine combined with conventional bupivacaine in a rhomboid intercostal block (RIB) to manage postoperative pain in patients undergoing video-assisted thoracoscopic surgery (VATS). VATS, a less invasive alternative to traditional thoracotomy, often leads to acute pain in over 80% of patients, which can cause complications and affect recovery. This study aims to evaluate and compare the effectiveness and safety of this novel anesthesia technique in a randomized controlled trial sponsored by Beijing Tiantan Hospital. Participants will receive either an ultrasound-guided rhomboid intercostal block with standard bupivacaine or a combination of liposomal bupivacaine plus bupivacaine before surgery. The block is performed via Doppler ultrasound with a 22-gauge needle at the T5-T6 level near the scapula, injecting 20 mL of the assigned anesthetic solution into the rhomboid-intercostal fascial plane. Postoperatively, all patients will have access to patient-controlled analgesia (PCA) with sufentanil and ondansetron, with additional oral oxycodone-acetaminophen or intravenous morphine if needed for pain relief. During the study, patients will be monitored for various outcomes including opioid use within 48 hours after surgery, pain scores at rest and during movement up to 3 months postoperatively, time to first analgesia request, sedation levels, recovery quality, length of hospital stay, and adverse events. Assessments occur frequently during the first 72 hours and at 1 week, 1 month, and 3 months after surgery. This comprehensive follow-up aims to measure both immediate and longer-term pain management and recovery, with study participation lasting up to three months post-surgery.
CONDITIONS
Brief Title
The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery
Who Can Participate
Age: 18Years - 64Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia
- Ages 18 to 64 years old
- American Society of Anesthesiologists (ASA) physical status of I-III
- Glasgow Coma Scale (GCS) score of 15
- Ability to understand the trial and provide informed consent
You will not qualify if you...
- History of chronic pain syndrome
- Heart conduction block (sinus or atrioventricular block)
- Unstable coronary artery disease
- Gastric ulcer or gastric bleeding
- Diabetes treated with insulin
- Coagulation dysfunction or use of oral anticoagulants not stopped before surgery
- Abnormal liver function (ALT/AST > 2x upper limit or bilirubin ≥ 1.5x upper limit)
- Renal impairment or dialysis within 28 days before surgery
- History of diagnosed mental illness or current psychotropic medication
- Excessive alcohol or drug abuse, chronic opioid use, or painkiller use within 24 hours before surgery
- Pregnancy or breastfeeding
- Extreme body mass index (BMI < 15 or > 35)
- Participation in another interventional trial affecting this study
- Allergy to local anesthetics or study drugs used in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Perioperative period including surgery and immediate postoperative care
Participants undergo video-assisted thoracoscopic surgery with an ultrasound-guided rhomboid intercostal nerve block using either liposomal bupivacaine plus bupivacaine or bupivacaine hydrochloride prior to surgical incision. Postoperative pain is managed with a patient-controlled analgesia pump and rescue medications as needed.
1 surgical visit and hospital stay for approximately 48 hours
Follow-up
Duration - Up to 3 months postoperatively
Participants are assessed for pain relief, analgesic use, and recovery at multiple time points up to 3 months after surgery.
Visits at 2 hours, 24 hours, 48 hours, 72 hours, 1 week, 1 month, and 3 months postoperatively
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
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Research Team
F
Fang Luo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Rhomboid intercostal block or thoracic paravertebral block for postoperative recovery quality after video-assisted thoracic surgery: A prospective, non-inferiority, randomised controlled trial.
Xuru Wang, Xiaoyu Jia, Zhenping Li...
https://pubmed.ncbi.nlm.nih.gov/37377368Efficacy and safety of rhomboid intercostal block for analgesia in breast surgery and thoracoscopic surgery: a meta-analysis.
Ruirong Chen, Sheng Su, Haihua Shu
https://pubmed.ncbi.nlm.nih.gov/35296252Comparison of Rhomboid Intercostal Block, Erector Spinae Plane Block, and Serratus Plane Block on Analgesia for Video-Assisted Thoracic Surgery: A Prospective, Randomized, Controlled Trial.
Jian-Guo Zhang, Chen-Wei Jiang, Wei Deng...
https://pubmed.ncbi.nlm.nih.gov/35832798