UMIN-CTR Clinical Trial

Public title

Efficacy of anterior quadratus lumborum block and pain after total hip arthroplasty

Acronym

Efficacy of posterior quadratus lumborum block and pain

Scientific Title

Efficacy of posterior quadratus lumborum block and pain after total hip arthroplasty: a randomized controlled trial

Scientific Title:Acronym

Efficacy of posterior quadratus lumborum block and pain after total hip arthroplasty

Region

Japan

Condition

Hip osteoarthritis, Femoral head necrosis, Femoral neck fracture, Subcondilare insufficient fracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Previous study reported, nerve blocks, periarticular analgesic injection, and multimodal analgesia with multiple medication provided favorable postoperative analgesia treatment after total hip arthroplasty. We have used femoral nerve block (FNB), periarticular analgesic injection, intra vascular fentanyl, and Non-Steroidal Anti-Inflammatory Drugs for postoperative analgesia. These analgesic treatments are providing more efficacy as postoperative analgesia., However, there is occasionally still occurring severe postoperative pain, and nausea and vomiting is recognized by increasing fentanyl administration after surgery. In this present study, we will investigate the analgesic effect of the quadratus lumborum block (QLB) undergoing primary THA patients. The QLB may block not only the femoral nerve but also the obturator nerve and the lateral femoral cutaneous nerve, thus possibly providing more effective analgesia in THA than FNB. Recent studies suggested that The QLB groups for primary total hip arthroplasty is associated with decreased opioid requirements up to 48 hours against non QLB groups. However, to our knowledge, the efficacy of the QLB against FNB was not shown at present moment. If we could demonstrate the efficacy of postoperative analgesia of QLB can expect to construct as a novel perioperative analgesia. The purpose of this study is to compare analgesia and opioid consumption for patients undergoing primary total hip arthroplasty with preoperative QLB with patients who receive FNB.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Post operative opioid consumption with patient controlled analgesia for 24 hours.

Key secondary outcomes

Numeric Rating Scale (NRS)of pain intensity at rest and movement at postoperative days 1 and 2.
Total dose of fentanyl; the total dose of intraoperative opioid and dose of postoperative opioid during 24 h after surgery.
the manual muscle test (MMT) results for the quadriceps muscle during days 1 and 2 of postoperative rehabilitation.
perioperative complications related to surgical or anesthetic procedures .

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Institution is considered as a block.

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

The quadratus lumborum block

Interventions/Control_2

The femoral nerve block

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

the patients underwent total hip arthroplasty with modified hardinge approach

Key exclusion criteria

Exclusion criteria included patients with dementia or mental disorders, known drug allergy or tolerance to study drugs, renal insufficiency or abnormal liver enzymes, severe cardiovascular disease, severe diabetes, who have undergone bilateral simultaneous THA, and who have not passed more than 6 months from previous the other side THA.

Target sample size

80

Name of lead principal investigator

1st name	Yu
Middle name
Last name	Takeda

Organization

Nishinomiya Kaisei Hospital

Division name

Department of Ortopaedic surgery

Zip code

6620957

Address

4-1, Ohama-cho, Nishinomiya, Hyogo, Japan

TEL

+81-798-33-0601

Email

Takeda.yu.0127@gmail.com

Name of contact person

1st name	Yu
Middle name
Last name	Takeda

Organization

Nishinomiya Kaisei Hospital

Division name

Department of Ortopaedic surgery

Zip code

6620957

Address

4-1, Ohama-cho, Nishinomiya, Hyogo, Japan

TEL

+81-798-33-0601

Homepage URL

Email

Takeda.yu.0127@gmail.com

Institute

Nishinomiya Kaisei Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nishinomiya institutional review board

Address

4-1, Ohama-cho, Nishinomiya, Hyogo, Japan

Tel

+81-798-33-0601

Email

kunimi.yuuki@hmw.gr.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

08

Month

13

Day

URL releasing protocol

https://doi.org/10.1016/j.arth.2023.05.044

Publication of results

Published

URL related to results and publications

https://doi.org/10.1016/j.arth.2023.05.044

Number of participants that the trial has enrolled

120

Results

There were no significant differences between the 2 groups concerning morphine consumption within 24 hours after surgery (P = .72). The NRS score at rest and passive motion were similar at all-time points (P > .05). However, there was a statistically significant difference in pain reported during the active motion for the FNB group compared to the AQLB (P = .04). No significant differences were found between the 2 groups concerning muscle weakness incidence.

Results date posted

2024

Year

08

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Patients recruited for the study were randomly assigned to 2 treatment groups: the FNB group and the AQLB group. All patients were consulted about the study protocol and gave informed consent. All patients were assigned to either the FNB or AQLB group based on a random number generated at the time of enrollment, which was generated by a computer software program (Excel for Mac 2022; Microsoft Redmond, Washington), ranging from 1 to 120. A number from a simple, random number generator was assigned to each patient who enrolled, and then each number was randomly assigned to a group. Participants were not informed of which group they were assigned. Although 120 patients were recruited for the current study, 10 patients were excluded due to their refusal to enroll in this study within 6 months of the contralateral surgery and a loss of data. Thus, 110 patients were included in this study and randomly allocated to the FNB group (n = 56) or AQLB group (n = 54). Only 1 identical patient was included. There were no significant differences between groups regarding average body mass index, age, length of surgery, blood loss, preoperative opioid use, history of depression, or allergies. A statistically significant difference between AQLB and FNB by gender; however, other baseline demographic data showed no significant differences between the 2 groups (P = .006).

Participant flow

In both groups, all patients received general anesthesia. The general anesthetic regime was as follows: anesthetic induction involved the administration of propofol, remifentanil, and a muscle relaxant to facilitate intubation. Propofol, remifentanil, sevoflurane, fentanyl citrate, and muscle relaxants were given for the maintenance of anesthesia. The AQLB was performed in the lateral position, and FNB was performed in the supine position. All procedures were performed with real-time ultrasonographic guidance following induction of general anesthesia by experienced anesthesiologists who are the first and second coauthors of this paper. In AQLB with a transverse approach, after the quadratus lumborum was visualized on sonography, 30 mL of local anesthetic (20 cc of 0.5 levobupivacaine 10 cc of saline) was infiltrated into the tissue plane between the quadratus lumborum and psoas muscles. In FNB, 15 mL of the local anesthetic (10 cc of 0.5 levobupivacaine 5 cc of saline) was infiltrated around the femoral nerve after visualizing the femoral nerve on sonography. For intraoperative pain control, the remifentanil infusion was adjusted within the range of 0.1 to 0.3 g/kg/min based on ideal body weight depending on surgical invasiveness. The estimated effect site concentration of fentanyl citrate at the end of the operation was adjusted to a range of 0.8 to 1.2 ng/mL. Intravenous acetaminophen was administered at the end of the surgery.

Adverse events

None

Outcome measures

The primary outcome was total fentanyl consumption over the initial 24 hour postoperative period, with total PCA morphine consumption recorded. Secondary outcomes included the pain score evaluation while at rest and during active and passive motion over the 2 days following surgery, the presence of any side effects (nausea, vomiting), and the manual muscle testing (MMT) of the quadriceps femoris (QF) muscle. The numerical rating scale (NRS) score (0, no pain; 10, worst pain imaginable) was used for evaluating the postoperative pain score. The NRS score at rest and during passive and active motion was recorded immediately after the patient returned to their room after surgery and at the 2, 4, 24 and 48 hour mark after surgery. The NRS during passive motion was evaluated with the straight leg being raised by the observer, and the NRS during active motion was evaluated by the presence of pain during hip flexion in the supine position.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2021

Year

03

Month

01

Day

Date of IRB

2021

Year

01

Month

12

Day

Anticipated trial start date

2021

Year

03

Month

01

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

08

Month

12

Day

Last modified on

2024

Year

08

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051572