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

NCT03541798 | Completed DMC

• 1 other identifier: 49/08
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

traditional sitting position; combine spinal-epidural anesthesia; orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• The number of epidural needle-bone contact

  3 months

Study Arms (3)

Traditional sitting position

ACTIVE COMPARATOR

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.

Procedure: positions of patients for combined spinal-epidural anesthesia; Procedure: Combined spinal epidural anesthesia

Harmstring stretch position

EXPERIMENTAL

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.

Procedure: positions of patients for combined spinal-epidural anesthesia; Procedure: Combined spinal epidural anesthesia

Squatting position

EXPERIMENTAL

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.

Procedure: positions of patients for combined spinal-epidural anesthesia; Procedure: Combined spinal epidural anesthesia

Interventions

positions of patients for combined spinal-epidural anesthesia PROCEDURE

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

Harmstring stretch position; Squatting position; Traditional sitting position

Combined spinal epidural anesthesia PROCEDURE

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.

Harmstring stretch position; Squatting position; Traditional sitting position

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Ankara, Altındag, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 24790901 RESULT

• 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.

  PMID: 29696117 RESULT

• 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.

  PMID: 19608828 RESULT

• 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.

  PMID: 33894856 DERIVED

Study Officials

• Ceyda Ö caparlar

  Dıskapı TRH

  STUDY DIRECTOR

• mehmet Ozhan

  private cankaya hospital, Ankara

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: randomized controlled study

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 31, 2018
• Study Start: May 1, 2019
• Primary Completion: August 20, 2019
• Study Completion: December 23, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)