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

Primary Purpose

Quadratus Lumborum Block, Thoracic Paravertebral Block, Postoperative Analgesia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Patient-controlled intravenous analgesia

Quadratus Lumborum Block

Thoracic Paravertebral Block

About this trial

This is an interventional other trial for Quadratus Lumborum Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Nanfang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Experimental

Other

Experimental

Arm Label

PCA for Open Hepatectomy

QLB for Open Hepatectomy

TPVB for Open hepatectomy

PCA for Laparoscopic Hepatectomy

QLB for Laparoscopic Hepatectomy

TPVB for Laparoscopic Hepatectomy

Arm 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)

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)

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)

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

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)

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)

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Total opioids consumption

The total amount of opioids consumed during perioperative period

Opioids consumption during hepatectomy Intraoperative opioids consumption

Total doses of opioids consumed during the surgical procedure intraoperatively

Opioids consumption after hepatectomy

Opioids consumption after hepatectomy which are administrated by Patient-controlled intravenous analgesia(PCIA) and by physician's order

First request of analgesia

Time to first request of rescue analgesic drug

Nausea

Incidence of postoperative nausea

Vomiting

Incidence of postoperative vomiting

Respiratory depression

Incidence of postoperative respiratory depression

Pruritus

Incidence of postoperative pruritus

Sedation Score

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.

Time to first off-bed activity

Postoperative activity

Lower extremity muscle strength

The muscle strength is divided into 6 levels.To observe the flexion of quadriceps.

Full Information

NCT ID

NCT03540537

First Posted

April 18, 2018

Last Updated

October 19, 2018

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03540537

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 9, 2018 (Actual)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PCA for Open Hepatectomy

Arm Type

Other

Arm Description

Arm Title

QLB for Open Hepatectomy

Arm Type

Experimental

Arm 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)

Arm Title

TPVB for Open hepatectomy

Arm Type

Experimental

Arm 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)

Arm Title

PCA for Laparoscopic Hepatectomy

Arm Type

Other

Arm Description

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

Arm Title

QLB for Laparoscopic Hepatectomy

Arm Type

Experimental

Arm 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)

Arm Title

TPVB for Laparoscopic Hepatectomy

Arm Type

Experimental

Arm 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)

Intervention Type

Other

Intervention Name(s)

Patient-controlled intravenous analgesia

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Quadratus Lumborum Block

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Thoracic Paravertebral Block

Intervention Description

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.

Primary Outcome Measure Information:

Title

VAS

Description

Time Frame

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

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Total opioids consumption

Description

The total amount of opioids consumed during perioperative period

Time Frame

From admitting in operation room to 48 hours after hepatectomy

Title

Opioids consumption during hepatectomy Intraoperative opioids consumption

Description

Total doses of opioids consumed during the surgical procedure intraoperatively

Time Frame

At the end of surgical procedure

Title

Opioids consumption after hepatectomy

Description

Opioids consumption after hepatectomy which are administrated by Patient-controlled intravenous analgesia(PCIA) and by physician's order

Time Frame

Up to 48 postoperative hrs

Title

First request of analgesia

Description

Time to first request of rescue analgesic drug

Time Frame

Up to 48 postoperative hrs

Title

Nausea

Description

Incidence of postoperative nausea

Time Frame

Up to 48 postoperative hrs

Title

Vomiting

Description

Incidence of postoperative vomiting

Time Frame

Up to 48 postoperative hrs

Title

Respiratory depression

Description

Incidence of postoperative respiratory depression

Time Frame

Up to 48 postoperative hrs

Title

Pruritus

Description

Incidence of postoperative pruritus

Time Frame

Up to 48 postoperative hrs

Title

Sedation Score

Description

Time Frame

Up to 48 postoperative hrs

Title

Time to first off-bed activity

Description

Postoperative activity

Time Frame

Up to discharge from hospital

Title

Lower extremity muscle strength

Description

The muscle strength is divided into 6 levels.To observe the flexion of quadriceps.

Time Frame

Up to 48 postoperative hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junyun Fan, Bachelor

Phone

0086-15920091179

Ext

86-020-627864

381774142@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bingsha Chen, Bachelor

Phone

0086-15802031635

1550688601@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tao Tao, MD

Organizational Affiliation

Nanfang Hospital, Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanfang Hospital of Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Tao, MD

Phone

0086-18617391219

taotaomzk@smu.edu.cn

First Name & Middle Initial & Last Name & Degree

Bingsha Chen, Bachelor

Phone

0086-15802031635

1550688601@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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