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

NCT03540537 | Unknown DMC

• 1 other identifier: NFEC-2017-190
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• VAS

  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.

  From 1 day before the surgery to the 2 days after surgery

• QoR-15/Quality of Recovery Scale 15(QoR-15)

  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.

  From 1 day before the surgery to the 2 days after surgery

Secondary Outcomes (11)

• Total opioids consumption

  From admitting in operation room to 48 hours after hepatectomy

• Opioids consumption during hepatectomy Intraoperative opioids consumption

  At the end of surgical procedure

• Opioids consumption after hepatectomy

  Up to 48 postoperative hrs

• First request of analgesia

  Up to 48 postoperative hrs

• Nausea

  Up to 48 postoperative hrs

Study Arms (6)

PCA for Open Hepatectomy

OTHER

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)

Other: Patient-controlled intravenous analgesia

QLB for Open Hepatectomy

EXPERIMENTAL

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)

Other: Patient-controlled intravenous analgesia; Other: Quadratus Lumborum Block

TPVB for Open hepatectomy

EXPERIMENTAL

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)

Other: Patient-controlled intravenous analgesia; Other: Thoracic Paravertebral Block

PCA for Laparoscopic Hepatectomy

OTHER

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

Other: Patient-controlled intravenous analgesia

QLB for Laparoscopic Hepatectomy

EXPERIMENTAL

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)

Other: Patient-controlled intravenous analgesia; Other: Quadratus Lumborum Block

TPVB for Laparoscopic Hepatectomy

EXPERIMENTAL

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)

Other: Patient-controlled intravenous analgesia; Other: Thoracic Paravertebral Block

Interventions

Patient-controlled intravenous analgesia OTHER

PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA 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; PCA for Open Hepatectomy; QLB for Laparoscopic Hepatectomy; QLB for Open Hepatectomy; TPVB for Laparoscopic Hepatectomy; TPVB for Open hepatectomy

Quadratus Lumborum Block OTHER

Ultrasound-guided Quadratus lumborum block: A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 20 ml of 0.375 % ropivacaine will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.

QLB for Laparoscopic Hepatectomy; QLB for Open Hepatectomy

Thoracic Paravertebral Block OTHER

Ultrasound-guided Thoracic paravertebral block: The patient is placed in the lateral position, the spinous processes of T6 and T8 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. Then 15 ml 0.375% ropivacaine is injected into the paravertebral space of T6 and T8.

TPVB for Laparoscopic Hepatectomy; TPVB for Open hepatectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

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Study Officials

• Tao Tao, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junyun Fan, Bachelor

CONTACT

0086-15920091179; 381774142@qq.com

Bingsha Chen, Bachelor

CONTACT

0086-15802031635; 1550688601@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 30, 2018
• Study Start: May 9, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 23, 2018

Record last verified: 2018-02

Locations

CN (1)