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

December 23, 2019 updated by: Ceyda Ozhan Caparlar, Diskapi Teaching and Research Hospital
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Altındag
      • Ankara, Altındag, Turkey, 06100
        • University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional sitting position

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.

Patients in groups will be positioned according to the study groups for performing combined spinal epidural anesthesia.
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.
Experimental: Harmstring stretch position

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.

Patients in groups will be positioned according to the study groups for performing combined spinal epidural anesthesia.
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.
Experimental: Squatting position

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.

Patients in groups will be positioned according to the study groups for performing combined spinal epidural anesthesia.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of identifying of epidural and subarachnoidal space
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of epidural needle-bone contact
Time Frame: 3 months
The number of epidural needle-bone contact for each positions
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ceyda Ö caparlar, Dıskapı TRH
  • Study Chair: mehmet Ozhan, private cankaya hospital, Ankara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

August 20, 2019

Study Completion (Actual)

December 23, 2019

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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