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Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks in Hip Fracture Surgery

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
control
LSP
CP
Ultrasound
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fractures focused on measuring circum-psoas blocks, lumbar plexus block, sacral plexus block, hip fracture surgery

Eligibility Criteria

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

Inclusion Criteria: Patient acceptance. BMI ≤ 30 kg/m2 ASA I-III. First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture. Patient with planned hip fracture surgery within 24-72 hours under general anesthesia. Exclusion Criteria: Multiple trauma, multiple fractures, or pathological fractures Prosthetic fracture or usage of bone-cement fixation in the surgery. Scheduled for bilateral hip fracture surgery. Pre-existing neurological deficit in the lower extremity Contraindication for peripheral nerve block (infection at the site of needle insertion, coagulopathy, allergy to local anesthetics used) History of chronic pain and taking analgesics History of cognitive dysfunction or mental illness

Sites / Locations

  • Shereen E Abd EllatifRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

control group

LSP group (lumbar and sacral plexus block)

CP group (circum-psoas block)

Arm Description

patients will be operated on under general anesthesia

patients will receive ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of 0.25% of bupivacaine.

patients will receive ultrasound-guided circum-psoas blocks with 40 ml of 0.25% of bupivacaine.

Outcomes

Primary Outcome Measures

Assess change of Visual analogue scale (VAS)
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain

Secondary Outcome Measures

Assess sensory block levels
by using alteration of pinprick sensation compared to the contralateral side on the dermatomes supplied by blocked nerves
Total dose of rescue analgesia
once the VAS score will be ≥ 3, rescue analgesia in the form of 1 μg/kg fentanyl will be given and the total dose consumed will be recorded

Full Information

First Posted
December 13, 2022
Last Updated
October 6, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05660603
Brief Title
Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks in Hip Fracture Surgery
Official Title
Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks for Sensory Level and Postoperative Analgesia Obtained in Hip Fracture Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig 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
Hip fracture (HF) is one of the major worldwide problems that constitute a significant mortality rate, ranging from 14- 36% in the first year after injury, and is associated with profound temporary and sometimes permanent impairment of independence and quality of life in the geriatric population. Surgical treatment is considered the best option for patients with hip fractures,s especially in the elderly, however, it is associated with moderate to severe postoperative pain. Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS). • Numerous regional anesthetic techniques have been used to provide analgesia following hip fracture surgery, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, and sacral plexus block, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for hip fracture surgery. To our knowledge, there is no study done to compare circum-psoas block versus the combined lumbar and sacral plexus blocks as pre-emptive analgesia in patients undergoing hip fracture surgery under general anesthesia.
Detailed Description
The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. Both the lumbar (L1-L4) and sacral (L4-S4) plexuses innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1. Hip fracture is a major worldwide public health problem in elderly patients aged 65 years and over with an incidence of more than 1.6 million worldwide each year. Furthermore, the total number is expected to exceed 6 million by 2050. Generally, early surgical repair within 48-72 hours after admission is recommended according to the treatment guideline, however, elderly patients with hip fractures commonly have several comorbidities, which make these patients more liable to a high risk of morbidity and mortality after surgery. Pain, both before and during the first 24 hours of surgery is usually reported as severe by most patients therefore, one of the keys to a patient's recovery following hip fracture surgery, is effective postoperative pain management. Recently, the concept of pain relief with multimodal analgesia and regional anesthesia plays a vital role in postoperative analgesia minimizing opioid consumption and reducing the time to early mobilization. The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. The lumbar (L1-L4) and sacral (L4-S4) plexuses both innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1. Hip fracture is a major worldwide public health problem in elderly patients aged 65 years and over with an incidence of more than 1.6 million worldwide each year. Furthermore, the total number is expected to exceed 6 million by 2050. Generally, early surgical repair within 48-72 hours after admission is recommended according to the treatment guideline, however, elderly patients with hip fractures commonly have several comorbidities, which make these patients more liable to a high risk of morbidity and mortality after surgery. Pain, both before and during the first 24 hours of surgery is usually reported as severe by most patients therefore, one of the keys to a patient's recovery following hip fracture surgery, is effective postoperative pain management. Recently, the concept of pain relief with multimodal analgesia and regional anesthesia plays a vital role in postoperative analgesia minimizing opioid consumption and reducing the time to early mobilization. Several regional anesthetic techniques have been recommended, including intrathecal morphine, patient-controlled epidural analgesia, and various peripheral nerve blocks techniques; however, to obtain complete sensory loss for hip fracture surgery, it's required to block the branches of both lumbar and sacral plexuses, although there remains no single technique that reliably acquires this. Moreover, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for hip fracture surgery. The ultrasound-guided lumbar plexus block results in the blockade of the FN, LFCN, and obturator nerve while the sacral plexus block results in the blockade of the sciatic nerve, superior and inferior gluteal nerves, posterior cutaneous nerve of the thigh, and the inferior hypogastric plexus. Thus, the combination of lumbar plexus and sacral plexus blocks results in complete analgesia of the ipsilateral lower limb in the perioperative period. Circum-psoas blocks is a new sonar-guided fascial block technique proposed by Huili et al., where the two main branches of the lumbar plexus (FN and LFCN) can be blocked by local anesthetic (LA) injection posterior to transversalis fascia (TF) and around the anterolateral edge of psoas muscle (PM) just cranial to iliac crest. Furthermore, cranial spread along TF may lead to a lower thoracic paravertebral block through the medial arcuate ligament. On the other hand, the obturator nerve and lumbosacral trunk could be blocked if the LA is injected at the level of L5/S1 into the retro-psoas space and around the posterior edge of PM. Our study will be designed to evaluate and compare the impact of combined lumbar and sacral plexus blocks and circum-psoas blocks for sensory level and achievement of postoperative analgesia for patients undergoing hip fracture surgery under general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
circum-psoas blocks, lumbar plexus block, sacral plexus block, hip fracture surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be divided randomly by a computer-generated randomization table into three groups : Group C :(Control group) patients will receive standard general anesthesia. Group LSP: patients will receive standard general anesthesia followed by combined lumbar and sacral plexus blocks with 40 ml of bupivacaine 0.25%. Group CP: patients will receive standard general anesthesia followed by circum-psoas block with 40 ml of bupivacaine 0.25%.
Masking
ParticipantOutcomes Assessor
Masking Description
double-blinded(participants and outcome assessors)
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
patients will be operated on under general anesthesia
Arm Title
LSP group (lumbar and sacral plexus block)
Arm Type
Active Comparator
Arm Description
patients will receive ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of 0.25% of bupivacaine.
Arm Title
CP group (circum-psoas block)
Arm Type
Active Comparator
Arm Description
patients will receive ultrasound-guided circum-psoas blocks with 40 ml of 0.25% of bupivacaine.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
patients will receive standard general anesthesia
Intervention Type
Procedure
Intervention Name(s)
LSP
Intervention Description
patients will receive standard general anesthesia followed by ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of bupivacaine 0.25%.
Intervention Type
Procedure
Intervention Name(s)
CP
Intervention Description
patients will receive standard general anesthesia followed by ultrasound-guided circum-psoas blocks with 40 ml of bupivacaine 0.25%.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
ultrasound
Primary Outcome Measure Information:
Title
Assess change of Visual analogue scale (VAS)
Description
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain
Time Frame
at 30 minutes, 2 hours, 4, 6,12, 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Assess sensory block levels
Description
by using alteration of pinprick sensation compared to the contralateral side on the dermatomes supplied by blocked nerves
Time Frame
at 2 hours postoperatively
Title
Total dose of rescue analgesia
Description
once the VAS score will be ≥ 3, rescue analgesia in the form of 1 μg/kg fentanyl will be given and the total dose consumed will be recorded
Time Frame
in the first 24 hour postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient acceptance. BMI ≤ 30 kg/m2 ASA I-III. First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture. Patient with planned hip fracture surgery within 24-72 hours under general anesthesia. Exclusion Criteria: Multiple trauma, multiple fractures, or pathological fractures Prosthetic fracture or usage of bone-cement fixation in the surgery. Scheduled for bilateral hip fracture surgery. Pre-existing neurological deficit in the lower extremity Contraindication for peripheral nerve block (infection at the site of needle insertion, coagulopathy, allergy to local anesthetics used) History of chronic pain and taking analgesics History of cognitive dysfunction or mental illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen E Abd Ellatif, MD
Phone
01007948840
Ext
002
Email
shosh.again@gmail.com
Facility Information:
Facility Name
Shereen E Abd Ellatif
City
Zagazig
State/Province
Alsharqia
ZIP/Postal Code
4115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen E Abd Ellatif, MD
Phone
01007948840
Ext
002
Email
shosh.again@gmail.com
First Name & Middle Initial & Last Name & Degree
Shereen E Abd Ellatif, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
planned after the completion of the study and publication
IPD Sharing Time Frame
planned after the completion of the study and publication
IPD Sharing Access Criteria
contact with principal investigator
Citations:
PubMed Identifier
16299013
Citation
Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.
Results Reference
background
PubMed Identifier
24974961
Citation
Bendtsen TF, Pedersen EM, Haroutounian S, Soballe K, Moriggl B, Nikolajsen L, Hasselstrom JB, Fisker AK, Strid JM, Iversen B, Borglum J. The suprasacral parallel shift vs lumbar plexus blockade with ultrasound guidance in healthy volunteers--a randomised controlled trial. Anaesthesia. 2014 Nov;69(11):1227-40. doi: 10.1111/anae.12753. Epub 2014 Jun 28.
Results Reference
background
PubMed Identifier
28611906
Citation
Petchara S, Paphon S, Vanlapa A, Boontikar P, Disya K. Combined Lumbar-Sacral Plexus Block in High Surgical Risk Geriatric Patients undergoing Early Hip Fracture Surgery. Malays Orthop J. 2015 Nov;9(3):28-34. doi: 10.5704/MOJ.1511.004.
Results Reference
background
PubMed Identifier
35378731
Citation
Li H, Shi R, Shao P, Wang Y. Evaluation of Sensory Loss Obtained by Circum-Psoas Blocks in Patients Undergoing Total Hip Replacement: A Descriptive Pilot Study. J Pain Res. 2022 Mar 29;15:827-835. doi: 10.2147/JPR.S354829. eCollection 2022.
Results Reference
background

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Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks in Hip Fracture Surgery

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