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Trial record 3 of 271782 for:    ALL

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

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ClinicalTrials.gov Identifier: NCT03508544
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Asst. Prof. Serkan Tulgar, M.D., Maltepe University

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Lumbar ESP block Procedure: QLB bLock Other: Standard Pain Followup and Monitorization Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Active Comparator: Lumbar ESP block
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
Procedure: Lumbar ESP block
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.
Other: Standard Pain Followup and Monitorization
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.
Active Comparator: QLB Block
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
Procedure: QLB bLock
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.
Other: Standard Pain Followup and Monitorization
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.
Sham Comparator: Control
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.
Other: Standard Pain Followup and Monitorization
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 Measures :
  1. Pain [ Time Frame: 24 hours ]
    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 :
  1. analgesic consumption [ Time Frame: 24 hours ]
    Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508544


Contacts
Contact: Serkan Tulgar, ass prof +905055423985 serkan.tulgar@maltepe.edu.tr

Locations
Turkey
Maltepe University faculty of medicine Recruiting
Istanbul, Turkey, 34090
Contact: serkan tulgar, ass prof    +905055423985    serkantulgar.md@gmail.com   
Sponsors and Collaborators
Maltepe University
Investigators
Principal Investigator: Serkan Tulgar, Ass Prof Maltepe University Faculity of Medicine

Publications:
Responsible Party: Asst. Prof. Serkan Tulgar, M.D., Assistant Professor, Maltepe University
ClinicalTrials.gov Identifier: NCT03508544     History of Changes
Other Study ID Numbers: Lumbar ESP vs QLB
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Lidocaine
Analgesics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action