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

Not Applicable

• Conditions: Hepatectomy; Postoperative Analgesia; Thoracic Paravertebral Block; Quadratus Lumborum Block
• Interventions: Other: Patient-controlled intravenous analgesia; Other: Thoracic Paravertebral Block; Other: Quadratus Lumborum Block

• Registration Number: NCT03540537
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-04-18
• Study Start: 2018-05-09
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-30
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-23
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPVB for Laparoscopic Hepatectomy	Patient-controlled intravenous analgesia	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)
QLB for Open Hepatectomy	Patient-controlled intravenous analgesia	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)
TPVB for Open hepatectomy	Thoracic Paravertebral Block	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)
TPVB for Open hepatectomy	Patient-controlled intravenous analgesia	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)
QLB for Open Hepatectomy	Quadratus Lumborum Block	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)
QLB for Laparoscopic Hepatectomy	Patient-controlled intravenous analgesia	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)
PCA for Open Hepatectomy	Patient-controlled intravenous analgesia	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)
PCA for Laparoscopic Hepatectomy	Patient-controlled intravenous analgesia	Patient-controlled intravenous analgesia in Laparoscopic hepatectomy (same as PCA for Open hepatectomy Arm)
QLB for Laparoscopic Hepatectomy	Quadratus Lumborum Block	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)
TPVB for Laparoscopic Hepatectomy	Thoracic Paravertebral Block	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)

Primary Outcome Measures

Name	Time	Method
QoR-15/Quality of Recovery Scale 15(QoR-15)	From 1 day before the surgery to the 2 days after surgery	The Quality of Recovery-15 scale (QoR-15) is an easy-to-use score for assessing the quality of post-operative recovery. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (n = 2), physical comfort (n = 5), physical independence (n = 2), psychological support (n = 2), and emotional state (n = 4) . Each item is scored from 0 to 10, and the possible total score ranges from 0 to 150. A higher total score means better patient QoR.
VAS	From 1 day before the surgery to the 2 days after surgery	The visual analogue scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In current study visual analogue scale is be adopt to assess pain of patients. The VAS ranges from 0-10,0 represents no pain and 10 represents the worst pain.

Secondary Outcome Measures

Name	Time	Method
Opioids consumption after hepatectomy	Up to 48 postoperative hrs	Opioids consumption after hepatectomy which are administrated by Patient-controlled intravenous analgesia(PCIA) and by physician's order
Nausea	Up to 48 postoperative hrs	Incidence of postoperative nausea
Time to first off-bed activity	Up to discharge from hospital	Postoperative activity
Opioids consumption during hepatectomy Intraoperative opioids consumption	At the end of surgical procedure	Total doses of opioids consumed during the surgical procedure intraoperatively
First request of analgesia	Up to 48 postoperative hrs	Time to first request of rescue analgesic drug
Lower extremity muscle strength	Up to 48 postoperative hrs	The muscle strength is divided into 6 levels.To observe the flexion of quadriceps.
Total opioids consumption	From admitting in operation room to 48 hours after hepatectomy	The total amount of opioids consumed during perioperative period
Vomiting	Up to 48 postoperative hrs	Incidence of postoperative vomiting
Sedation Score	Up to 48 postoperative hrs	A score to evaluate patients' sedation deepness Sedation score will be assessed with 'Modified Observer's assessment of alertness/sedation (OAA/S) score'. The OAA/S Scale is composed of the following categories: (1) responsiveness, (2) speech, (3) facial expression, and (4) eyes. The OAA/S Scale can be scored in two ways: the composite score, with a range of 1 (deep sleep) to 5 (alert), in any one of the four assessment categories and the sum of the four component scores, where responsiveness has possible scores of 1, 2, 3, 4 or 5, speech has scores of 2, 3, 4 or 5, and facial expression and eyes have scores of 3, 4 or 5.
Respiratory depression	Up to 48 postoperative hrs	Incidence of postoperative respiratory depression
Pruritus	Up to 48 postoperative hrs	Incidence of postoperative pruritus

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China