A Trial Comparing Quadratus Lumborum Block (QLB) and Paravertebral Block (PVTB) for Postoperative Analgesia in Hepatectomy

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Postoperative Analgesia; Quadratus Lumborum Block; Hepatectomy; Thoracic Paravertebral Block

Treatments: Other: Thoracic Paravertebral Block; Other: Patient-controlled intravenous analgesia; Other: Quadratus Lumborum Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03540537

NFEC-2017-190

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 6 patient groups

PCA for Open Hepatectomy

Other group

Description:

Patient-controlled intravenous analgesia in Open hepatectomy (PCA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing)

Treatment:

Other: Patient-controlled intravenous analgesia

QLB for Open Hepatectomy

Experimental group

Description:

Bilateral quadratus lumborum block with 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)

Treatment:

Other: Patient-controlled intravenous analgesia

Other: Quadratus Lumborum Block

TPVB for Open hepatectomy

Experimental group

Description:

T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)

Treatment:

Other: Patient-controlled intravenous analgesia

Other: Thoracic Paravertebral Block

PCA for Laparoscopic Hepatectomy

Other group

Description:

Patient-controlled intravenous analgesia in Laparoscopic hepatectomy (same as PCA for Open hepatectomy Arm)

Treatment:

Other: Patient-controlled intravenous analgesia

QLB for Laparoscopic Hepatectomy

Experimental group

Description:

Bilateral quadratus lumborum block 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)

Treatment:

Other: Patient-controlled intravenous analgesia

Other: Quadratus Lumborum Block

TPVB for Laparoscopic Hepatectomy

Experimental group

Description:

T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)

Treatment:

Other: Patient-controlled intravenous analgesia

Other: Thoracic Paravertebral Block