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Comparison of Three Different Sitting Positions for Performing Combined Spinal-Epidural Anesthesia

Primary Purpose

Anesthesia; Adverse Effect, Spinal and Epidural, Hip Arthropathy, Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
positions of patients for combined spinal-epidural anesthesia
Combined spinal epidural anesthesia
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anesthesia; Adverse Effect, Spinal and Epidural focused on measuring traditional sitting position, combine spinal-epidural anesthesia, orthopedic surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ASA I-II, 18-70 years, combine spinal-epidural anesthesia for elective orthopedic surgery

Exclusion Criteria: hypertension, thrombocytopenia, high intracranial pressure, Alzheimer Disease, local anesthetic allegic

Sites / Locations

  • University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Traditional sitting position

Harmstring stretch position

Squatting position

Arm Description

Patient is positioned with her knees flexed 90o, both feet hanging of the bed and propped up by a chair, both arms hugging a pillow, adducted pelvic, maximum pelvic flexion were done to create maximal sagittal lumbal flexion before spinal anesthesia begun. Intervention: A combined spinal epidural anesthesia (CSE) will be applied using a CSE Tuohy Needle (18 G) and 27 G Whitacre spinal needle via needle - through needle technique. The epidural space will be located with loss of resistance to saline. 3 ml hyperbaric bupivacaine 0.5% (15 mg) will be given for spinal anesthesia.

the patients sit up from supine position with the legs remaining on the operating table, knees are maximally extended. Intervention: A combined spinal epidural anesthesia (CSE) will be applied using a CSE Tuohy Needle (18 G) and 27 G Whitacre spinal needle via needle - through needle technique. The epidural space will be located with loss of resistance to saline. 3 ml hyperbaric bupivacaine 0.5% (15 mg) will be given for spinal anesthesia.

the patients sit up from supine position with the legs remaining on the operating table, hips and knees are maximally flexed . Intervention: A combined spinal epidural anesthesia (CSE) will be applied using a CSE Tuohy Needle (18 G) and 27 G Whitacre spinal needle via needle - through needle technique. The epidural space will be located with loss of resistance to saline. 3 ml hyperbaric bupivacaine 0.5% (15 mg) will be given for spinal anesthesia.

Outcomes

Primary Outcome Measures

Ease of identifying of epidural and subarachnoidal space
After positioning of patients for CSE according to groups, the block performer will palpate the iliac crest on both sides. The horizontal line between iliac crests will be used to define the level of the lumbar vertebrae. The lumbar spinous processes of L2, L3,L4, and L5 vertebra levels will be palpated and the palpability of the spinous processes will be graded by the performer to find - out best and the second best interspinous space between spinous processes as follows: easily palpable(score=2), hardly palpable (score=1) and impalpable (score=0). An interspinous space with two easy palpable spinous process will be defined as best interspinous space.An interspinous space with one easy palpable spinous process and a hardly palpable spinous processes will be defined as second best interspinous space. When all spinous processess are impalpable, the performer should choose an interspinous space to perform CSE.

Secondary Outcome Measures

The number of epidural needle-bone contact
The number of epidural needle-bone contact for each positions

Full Information

First Posted
May 17, 2018
Last Updated
December 23, 2019
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03541798
Brief Title
Comparison of Three Different Sitting Positions for Performing Combined Spinal-Epidural Anesthesia
Official Title
Comparison of Three Different Sitting Positions for Performing Combined Spinal-Epidural Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
In this prospective and randomized study, we aimed to compare the effect of of three sitting positions (the traditional sitting position (TSP), the harmstring stretch position (HSP), and the squatting position on the success rate of combined spinal epidural anesthesia in patients undergoing total knee arhtoplasty (TKA) or total hip arthroplasty (THA) surgery.
Detailed Description
Positioning of patients plays a major role to identify accurately epidural and/or spinal spaces for neuraxial blocks. Flexed back is considered mandatory to widen the inter spinous space in traditional lateral and sitting positions. In traditional sitting position (TSP), the patient is positioned in a sitting posture on the operating table. A stool is placed by the side of the operating table to support the legs. Both hips and knees are maximally flexed. In recent years, several studies suggested that the reduction of lumbar lordosis may increase the success rate of spinal or epidural block and reduce needle-bone contact. Different modified sitting positions were described for this aim: the harmstring stretch position (HSP), the squatting position (SP), and the crossed-leg position (CLP). In modified sitting positions, the patients sit up from supine position with the legs remaining on the operating table, either knees are maximally extended (the harmstring stretch position), or hips and knees are maximally flexed (the squatting position), or hips and knees are flexed with crossing the legs (the crossed leg position). All studies comparing modified sitting positions with TSP found that the success rate and number of needle bone contacts were similar except one study which reported a lower needle bone contact with squatting position. Other factors contributing the success of the neuraxial block were: anatomical landmarks (palpability of the spinous processes, identification of the midline), immobilization of the patient during the injection, and the provider's level of experience. The combined spinal - epidural (CSE) technique has been increasingly used for over thirty years which consist of intentional injection of a local anesthetic into the subarachnoidal space and the placement of a catheter into epidural space to prolong or modify the block. Although CSE technique combines the best features of spinal and epidural blockade, it is a more complicated to perform. Studies comparing CSE with epidural and/or spinal technique reported similar failure rates but most of them did not focuse on the effect of patient's positioning. In this prospective and randomized study, we aimed to compare the effect of of three sitting positions (the traditional sitting position (TSP), the harmstring stretch position (HSP), and the squatting position (SP) on the success rate of CSE anesthesia in patients undergoing total knee arhtoplasty (TKA) or total hip arthroplasty (THA) surgery. The CLSP was not included in the study design because the crossing the legs during the procedure seemed to be painful and difficult in patients with degenerated knee joints. Our primary endpoint was the number of needle bone contact and the secondary endpoint was ease of needle insertion/space identification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Adverse Effect, Spinal and Epidural, Hip Arthropathy, Knee Arthropathy
Keywords
traditional sitting position, combine spinal-epidural anesthesia, orthopedic surgery

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional sitting position
Arm Type
Active Comparator
Arm Description
Patient is positioned with her knees flexed 90o, both feet hanging of the bed and propped up by a chair, both arms hugging a pillow, adducted pelvic, maximum pelvic flexion were done to create maximal sagittal lumbal flexion before spinal anesthesia begun. Intervention: A combined spinal epidural anesthesia (CSE) will be applied using a CSE Tuohy Needle (18 G) and 27 G Whitacre spinal needle via needle - through needle technique. The epidural space will be located with loss of resistance to saline. 3 ml hyperbaric bupivacaine 0.5% (15 mg) will be given for spinal anesthesia.
Arm Title
Harmstring stretch position
Arm Type
Experimental
Arm Description
the patients sit up from supine position with the legs remaining on the operating table, knees are maximally extended. Intervention: A combined spinal epidural anesthesia (CSE) will be applied using a CSE Tuohy Needle (18 G) and 27 G Whitacre spinal needle via needle - through needle technique. The epidural space will be located with loss of resistance to saline. 3 ml hyperbaric bupivacaine 0.5% (15 mg) will be given for spinal anesthesia.
Arm Title
Squatting position
Arm Type
Experimental
Arm Description
the patients sit up from supine position with the legs remaining on the operating table, hips and knees are maximally flexed . Intervention: A combined spinal epidural anesthesia (CSE) will be applied using a CSE Tuohy Needle (18 G) and 27 G Whitacre spinal needle via needle - through needle technique. The epidural space will be located with loss of resistance to saline. 3 ml hyperbaric bupivacaine 0.5% (15 mg) will be given for spinal anesthesia.
Intervention Type
Procedure
Intervention Name(s)
positions of patients for combined spinal-epidural anesthesia
Intervention Description
Patients in groups will be positioned according to the study groups for performing combined spinal epidural anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Combined spinal epidural anesthesia
Intervention Description
After positioning, a combined spinal epidural anesthesia (CSE) will be applied using a CSE Tuohy Needle (18 G) and 27 G Whitacre spinal needle via needle - through needle technique. The epidural space will be located with loss of resistance to saline. 3 ml hyperbaric bupivacaine 0.5% (15 mg) will be given for spinal anesthesia after identification of subarachnoidal space.
Primary Outcome Measure Information:
Title
Ease of identifying of epidural and subarachnoidal space
Description
After positioning of patients for CSE according to groups, the block performer will palpate the iliac crest on both sides. The horizontal line between iliac crests will be used to define the level of the lumbar vertebrae. The lumbar spinous processes of L2, L3,L4, and L5 vertebra levels will be palpated and the palpability of the spinous processes will be graded by the performer to find - out best and the second best interspinous space between spinous processes as follows: easily palpable(score=2), hardly palpable (score=1) and impalpable (score=0). An interspinous space with two easy palpable spinous process will be defined as best interspinous space.An interspinous space with one easy palpable spinous process and a hardly palpable spinous processes will be defined as second best interspinous space. When all spinous processess are impalpable, the performer should choose an interspinous space to perform CSE.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The number of epidural needle-bone contact
Description
The number of epidural needle-bone contact for each positions
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I-II, 18-70 years, combine spinal-epidural anesthesia for elective orthopedic surgery Exclusion Criteria: hypertension, thrombocytopenia, high intracranial pressure, Alzheimer Disease, local anesthetic allegic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ceyda Ö caparlar
Organizational Affiliation
Dıskapı TRH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mehmet Ozhan
Organizational Affiliation
private cankaya hospital, Ankara
Official's Role
Study Chair
Facility Information:
Facility Name
University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
City
Ankara
State/Province
Altındag
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24790901
Citation
Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.
Results Reference
result
PubMed Identifier
29696117
Citation
Soltani Mohammadi S, Piri M, Khajehnasiri A. Comparing Three Different Modified Sitting Positions for Ease of Spinal Needle Insertion in Patients Undergoing Spinal Anesthesia. Anesth Pain Med. 2017 Oct 23;7(5):e55932. doi: 10.5812/aapm.55932. eCollection 2017 Oct.
Results Reference
result
PubMed Identifier
19608828
Citation
Fisher KS, Arnholt AT, Douglas ME, Vandiver SL, Nguyen DH. A randomized trial of the traditional sitting position versus the hamstring stretch position for labor epidural needle placement. Anesth Analg. 2009 Aug;109(2):532-4. doi: 10.1213/ane.0b013e3181ac6c79. Erratum In: Anesth Analg. 2009 Oct;109(4):1208.
Results Reference
result
PubMed Identifier
33894856
Citation
Ozhan MO, Caparlar CO, Suzer MA, Eskin MB, Atik B. Comparison of three sitting positions for combined spinal - epidural anesthesia: a multicenter randomized controlled trial. Braz J Anesthesiol. 2021 Mar-Apr;71(2):129-136. doi: 10.1016/j.bjane.2020.12.012. Epub 2020 Dec 28.
Results Reference
derived

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Comparison of Three Different Sitting Positions for Performing Combined Spinal-Epidural Anesthesia

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