Efficacy of Liposomal Bupivacaine for Transversus Abdominis Plane Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTianjin First Central Hospital
About this trial
This is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Eligible participants will be randomly assigned to receive either liposomal bupivacaine or ropivacaine for TAP block during surgery. The primary outcome is the dynamic NRS pain score at 24 hours after surgery. Secondary outcomes include static and dynamic NRS pain scores at multiple time points, QoR-15 recovery quality, time to first rescue analgesia, analgesic consumption, gastrointestinal function recovery, length of hospital stay, and adverse events. Participants will be followed up to 3 months after surgery to evaluate the incidence of chronic post-surgical pain (CPSP). All participants will receive routine clinical care, and participation is voluntary.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years, either gender.
Patients scheduled for elective laparoscopic cholecystectomy.
ASA physical status I-III.
Able to provide written informed consent and complete the 3-month follow-up.
Disqualifiers
History of allergy to local anesthetics.
History of dementia, psychosis, or other central nervous system diseases.
History of chronic pain or long-term use of opioids or other analgesics.
Contraindications to nerve block: infection at puncture site, severe coagulopathy.
Trial design
Design model
Parallel
Treatments tested in this trial
Liposomal Bupivacaine TAP block
DrugLiposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.
Ropivacaine TAP blocks
DrugStandard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Liposomal Bupivacaine GroupExperimental treatment 1 intervention
Group B: Ropivacaine groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative dynamic NRS pain score at 24 hours
Postoperative pain intensity under dynamic conditions (e.g., coughing or deep breathing) will be assessed using the Numerical Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain).
Time frame
24 hours after surgerySecondary outcomes
1
Postoperative NRS pain scores at different time points
NRS scores at 24, 48, and 72 hours post-surgery while at rest; NRS scores at 48 and 72 hours while active
Time frame
24, 48, and 72 hours after surgery2
Postoperative recovery quality (QoR-15 scale)
Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery (QoR-15) scale at 24 hours after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality.
Time frame
24, 48, and 72 hours after surgery3
Time to first rescue analgesia
The time from the end of surgery to the first request for rescue analgesia (e.g., opioid or non-opioid analgesics) will be recorded（background pain is excluded）.
Time frame
Up to 72 hours after surgery4
Total postoperative analgesic consumption within 72 hours
Total amount of rescue analgesics (e.g., opioids, NSAIDs) used by each patient within 72 hours after surgery will be calculated and converted into equivalent doses.
Time frame
72 hours after surgeryOther outcomes
1
Incidence of chronic post-surgical pain (CPSP) at 3 months
The incidence of chronic post-surgical pain will be assessed via telephone follow-up.Incidence of chronic post-surgical pain (CPSP) , defined as persistent pain (NRS ≥ 1) at the surgical site lasting ≥ 3 months after laparoscopic cholecystectomy, excluding pain caused by other etiologies.
Time frame
3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov