search
Back to results

Lumbar Erector Spinae Plane Block and Quadratus Lumborum Block in Hip and Proximal Femur Surgeries

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lumbar ESP block
QLB bLock
Standard Pain Followup and Monitorization
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Hip joint and proxiaml femur surgery, ASA 1-2-3

Exclusion Criteria:

  • Patient refusal
  • Contraindications to regional anesthesia
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Inability to operate PCA system
  • Patient with psychiatric disorders

Sites / Locations

  • Maltepe University faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Lumbar ESP block

QLB Block

Control

Arm Description

Ultrasound-guided lumbar Erector spinae plane (ESP) block performed at the begining of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed

Ultrasound-guided transmuscular quadratus lumborum block (QLB) performed at the begining of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed

Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.

Outcomes

Primary Outcome Measures

Pain
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Secondary Outcome Measures

analgesic consumption
Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using

Full Information

First Posted
April 16, 2018
Last Updated
June 6, 2018
Sponsor
Maltepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT03508544
Brief Title
Lumbar Erector Spinae Plane Block and Quadratus Lumborum Block in Hip and Proximal Femur Surgeries
Official Title
Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block in Hip and Proximal Femur Surgery, Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
May 21, 2018 (Actual)
Study Completion Date
June 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multimodal analgesia is used to control postoperative pain in hip surgery. Quadratus lumborum block is an effective regional anesthesia technique for hip and proximal femur surgery. The erector spinae plane block applied to the lumbar region was also reported to provide effective analgesia in these surgeons. In this study, we aimed to determine and compare the effects of quadratus lumborum block and lumbar erector spinae plane block on postoperative pain in hip and proximal femur surgeons.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar ESP block
Arm Type
Active Comparator
Arm Description
Ultrasound-guided lumbar Erector spinae plane (ESP) block performed at the begining of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed
Arm Title
QLB Block
Arm Type
Active Comparator
Arm Description
Ultrasound-guided transmuscular quadratus lumborum block (QLB) performed at the begining of the surgery with 40 ml of a bupivacaine/lidocaine mixture. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
Intervention Type
Procedure
Intervention Name(s)
Lumbar ESP block
Intervention Description
Lumbar ESP block will be performed at the begining of surgery under ganeral anesthesia. A convex ultrasound transducer will be placed in a longitudinal parasagittal orientation 4-6 cm lateral to L4 spinous process. The erector spinae muscles will be identified superficial to the tip of L4 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 40 mL of bupivacaine/lidocaine mixture will be injected.
Intervention Type
Procedure
Intervention Name(s)
QLB bLock
Intervention Description
QLB block will be performed at the begining of surgery under ganeral anesthesia. The convex transducer will be placed in the transverse plane on the flank of the patient cranial to the iliac crest.The 4th lumbar vertebral transverse process, erector spinae muscles, psoas muscles, transverse abdominis muscles, internal and external oblique muscles and the quadratus lumborum muscles will be identified. A 15cm 22G insulated needle will be inserted on the posterior corner of the convex probe. 40 ml of local anesthetic mixture(bupivacaine and lidocaine ) will be administered between the quadratus lumborum and psoas muscles into the fascial plane. We observed the local anesthetic pressing down on the psoas muscle in the ultrasound image.
Intervention Type
Other
Intervention Name(s)
Standard Pain Followup and Monitorization
Intervention Description
Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
Primary Outcome Measure Information:
Title
Pain
Description
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
analgesic consumption
Description
Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Hip joint and proxiaml femur surgery, ASA 1-2-3 Exclusion Criteria: Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system Patient with psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serkan Tulgar, Ass Prof
Organizational Affiliation
Maltepe University Faculity of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maltepe University faculty of medicine
City
Istanbul
ZIP/Postal Code
34090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29522966
Citation
Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
Results Reference
background
PubMed Identifier
29534382
Citation
He J, Zheng XQ, Luo CH, Huang ZX, He WY, Wang HB, Yang CX. [Effects and safety of quadratus lumborum block in analgesia after hip arthroplasty]. Zhonghua Yi Xue Za Zhi. 2018 Feb 27;98(8):565-569. doi: 10.3760/cma.j.issn.0376-2491.2018.08.002. Chinese.
Results Reference
background
PubMed Identifier
27185672
Citation
Ueshima H, Yoshiyama S, Otake H. RETRACTED: The ultrasound-guided continuous transmuscular quadratus lumborum block is an effective analgesia for total hip arthroplasty. J Clin Anesth. 2016 Jun;31:35. doi: 10.1016/j.jclinane.2015.12.033. Epub 2016 Mar 22. No abstract available.
Results Reference
background

Learn more about this trial

Lumbar Erector Spinae Plane Block and Quadratus Lumborum Block in Hip and Proximal Femur Surgeries

We'll reach out to this number within 24 hrs