Clinical trial NCT03540537: A Trial Comparing Quadratus Lumborum Block (QLB) and Paravertebral Block (PVTB) for Postoperative Analgesia in Hepatectomy
Official title: A Randomized Controlled Trial Comparing Quadratus Lumborum Block and Paravertebral Block for Postoperative Analgesia in Laparoscopic Hepatectomy and Open Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quadratus Lumborum Block
Thoracic Paravertebral Block
Postoperative Analgesia
Hepatectomy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pain after hepatectomy can interfere with the patients' recovery and may contribute to developing long term pain. Opioids, e.g. morphine, fentanyl, sufentanil, works well for postoperative analgesia, but have several side effects such as nausea, vomiting and itching which may be severe enough to affect patients' recovery. In some cases, opioids may cause constipation and urinary retention within the first 24 hours after surgery. Thus, several ultrasound-guided nerve block procedures have been applied to provide postoperative analgesia. Ultrasound-guided thoracic paravertebral block (TPVB) is one of the most used nerve block methods using for post-hepatectomy analgesia. However, in some cases, ultrasound-guided TPVB can cause pneumothorax, hemopneumothorax, and higher block level. The quadratus lumborum block (QLB) is a new developed nerve block which can provide a widespread analgesic effect from T7 to L1. Therefore, this study is to determine whether QLB or TPVB have a better pain control with fewer side effects and complications after laparoscopic and open hepatectomy. The adequate pain control will be assessed by their visual analogue score (VAS) and the postoperative quality of recovery scale (QoR-15, Chinese Version). Additionally, the side effect and complications profile of these two nerve block techniques will also be recorded and compared.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 65 years old for selective hepatectomy from nanfang Hospital, Southern Medical University
* American Society of Anesthesiologists (ASA) risk class I-III;
* Body Mass Index (BMI) is not lesser than 18 and not greater than 30;

Exclusion Criteria:

* Patients refuse to participate
* Allergy to the any agents used in current clinical trial;
* Dependence, tolerance or excessive sensitivity to the anesthetics and psychotropic drugs;
* Patients with nerve block contraindications (e.g. local infection of skin or soft tissue in injection site, serious bleeding tendency or hemorrhagic disease, anatomical aberration which make anesthesiologist cannot perform the ultrasound-guided nerve block, allergic history of local anesthetics, etc.);
* Previous abdominal surgery (except for diagnostic biopsy);
* New York Heart Association (NYHA) classification of cardiac function grade IV and/or Ejection Fraction (EF)≤55%;
* Child-Pugh grading
* Liver function of grade C (Child-Pugh grading)
* Glomerular filtration rate≤60ml/min/1.73m2;
* Obstructive sleep apnea syndrome;
* Chronic obstructive pulmonary disease, asthma, active tuberculosis;
* Cardiac rhythm disorders;
* Past or present history of nervous system diseases and mental disorders (such as epilepsy, Alzheimer's disease, Parkinsonism syndrome, depression,etc.);
* Autoimmune diseases (such as lupus erythematosus, rheumatoid arthritis,etc.)
* Malignant tumors of other systems;
* Other operations are required during the same period;

Primary outcomes:
measure: VAS
timeFrame: From 1 day before the surgery to the 2 days after surgery
measure: QoR-15/Quality of Recovery Scale 15(QoR-15)
timeFrame: From 1 day before the surgery to the 2 days after surgery
Secondary outcomes:
measure: Total opioids consumption
timeFrame: From admitting in operation room to 48 hours after hepatectomy
measure: Opioids consumption during hepatectomy Intraoperative opioids consumption
timeFrame: At the end of surgical procedure
measure: Opioids consumption after hepatectomy
timeFrame: Up to 48 postoperative hrs
measure: First request of analgesia
timeFrame: Up to 48 postoperative hrs
measure: Nausea
timeFrame: Up to 48 postoperative hrs
measure: Vomiting
timeFrame: Up to 48 postoperative hrs
measure: Respiratory depression
timeFrame: Up to 48 postoperative hrs
measure: Pruritus
timeFrame: Up to 48 postoperative hrs
measure: Sedation Score
timeFrame: Up to 48 postoperative hrs
measure: Time to first off-bed activity
timeFrame: Up to discharge from hospital
measure: Lower extremity muscle strength
timeFrame: Up to 48 postoperative hrs
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Tao Tao, MD
role: PRINCIPAL_INVESTIGATOR
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