Liver Surgery
Conditions
Brief summary
This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery.
Interventions
PROCEDUREUltrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament
Bilateral single-injection 20 ml 0.56% ropivacaine. Intravenous analgesia was started postoperatively and consisted of 1ug/ml sufentanil，2 ml/h with a 5-minute lockout period, a limited 12 ml/h dose.
PROCEDUREThoracic epidural analgesia
A thoracic epidural at the level of T7-10. Epidural infusion was started postoperatively and consisted of sufentanil (0.6ug/mL) and ropivacaine（0.2%） at 3ml/h.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥18 years * ASA I-III * Open liver surgery
Exclusion criteria
* Contraindication to nerve block or epidural puncture * Chronic use of opioids or NSAIDs * Refused to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS (numeric rating scale) score for coughing pain | at 24 hours after surgery | Postoperative pain was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| consumption of opioid converted to IV morphine equivalents | during 24 hours after surgery | opioids given postoperatively converted to IV morphine equivalents |
| Numbers of additional analgesics | during 72 hours after surgery | Additional rescue analgesics were used when pain relief was inadequate (NRS \>3). The choice of rescue analgesic was oxydone 5-10mg. |
| The incidence of postoperative hypotension | during 72 hours after surgery | Adverse reactions related to analgesia |
| The incidence of nausea and vomiting | during 72 hours after surgery | Adverse reactions related to analgesia |
| The incidence of pruritus | during 72 hours after surgery | Adverse reactions related to analgesia |
| The incidence of respiratory depression | during 72 hours after surgery | Adverse reactions related to analgesia |
| NRS score for rest and coughing pain | at 1, 6, 24, 48, 72 hours after surgery | Postoperative pain at rest and during coughing was assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain) |
| Time to eat in days | through study completion, an average of 2-3 days | Time to start eating after surgery |
| Time to flatus in hours | through study completion, an average of 40-50 hours | Time to flatus after surgery |
| Time to defecation in hours | through study completion, an average of 60-70 hours | Time to defecation after surgery |
| Time to urethral catheter removal in hours | through study completion, an average of 60-70 hours | Time tourethral catheter removal after surgery |
| Postoperative hospital stay in days | through study completion, an average of 7-8 days | The time from operation to discharge |
| Clavien-Dindo classification (grade I, II, III, IV) for postoperative complication | One month after surgery | Postoperative Clavien-Dindo complication classification |
| Time to ambulation in days | through study completion, an average of 2-3 days | Postoperative ambulation time |
Countries
China
Outcome results
None listed