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

Postoperative Analgesia Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Quadratus Lumborum Block and Paravertebral Block for Postoperative Analgesia in Laparoscopic Hepatectomy and Open Hepatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540537
• Other study ID #: NFEC-2017-190
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Junyun Fan, Bachelor
• Phone: 0086-15920091179
• Email: 381774142[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

Other:
• Patient-controlled intravenous analgesia
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
• Quadratus Lumborum Block
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.
• Thoracic Paravertebral Block
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.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Total opioids consumption	The total amount of opioids consumed during perioperative period	From admitting in operation room to 48 hours after hepatectomy
Secondary	Opioids consumption during hepatectomy Intraoperative opioids consumption	Total doses of opioids consumed during the surgical procedure intraoperatively	At the end of surgical procedure
Secondary	Opioids consumption after hepatectomy	Opioids consumption after hepatectomy which are administrated by Patient-controlled intravenous analgesia(PCIA) and by physician's order	Up to 48 postoperative hrs
Secondary	First request of analgesia	Time to first request of rescue analgesic drug	Up to 48 postoperative hrs
Secondary	Nausea	Incidence of postoperative nausea	Up to 48 postoperative hrs
Secondary	Vomiting	Incidence of postoperative vomiting	Up to 48 postoperative hrs
Secondary	Respiratory depression	Incidence of postoperative respiratory depression	Up to 48 postoperative hrs
Secondary	Pruritus	Incidence of postoperative pruritus	Up to 48 postoperative hrs
Secondary	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.	Up to 48 postoperative hrs
Secondary	Time to first off-bed activity	Postoperative activity	Up to discharge from hospital
Secondary	Lower extremity muscle strength	The muscle strength is divided into 6 levels.To observe the flexion of quadriceps.	Up to 48 postoperative hrs