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Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients

Primary Purpose

Spinal Anesthesia, Ultrasound Assistance, Obesity, Morbid

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Paramedian conventional palpation group
Ultrasound assistance paramedian spinal group
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Both sexes
  • Body mass index (BMI) ≥ 40 kg/m2
  • Patients undergoing elective surgeries

Exclusion Criteria:

  • Rejection of spinal anesthesia
  • History of spinal deformity or spinal surgery
  • Contraindications to spinal anesthesia (infection of the puncture site, coagulation dysfunction, allergy to local anesthesia, insufficient blood volume or abnormal spinal anatomy).

Sites / Locations

  • Kafr El-Sheikh University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Paramedian conventional palpation group

Ultrasound assistance paramedian spinal group

Arm Description

Patients in this group underwent conventional landmark guided paramedian spinal anesthetic. The spinal anesthesia will be administered based on conventional landmark-based paramedian approach.

This group will have their spinal anesthetic done based on Ultrasound assistance paramedian spinal.

Outcomes

Primary Outcome Measures

The rate of successful dural puncture on the first attempt
First-attempt success rate will be recorded

Secondary Outcome Measures

Total success rate of spinal anesthesia
Successful Dural Puncture Rates for Selected Number of Attempts and Passes in both intervention groups
Adverse reactions during puncture
Adverse reactions during puncture as incidence of nerve stimulation
Complications after anesthesia
Complications after anesthesia as incidence of low back pain
Patients' satisfaction after surgery
6- Degree of patient satisfaction will be assessed on a 3-point scale; (1= unsatisfied 2= neither satisfied nor unsatisfied 3= satisfied)

Full Information

First Posted
February 4, 2022
Last Updated
September 3, 2023
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT05240846
Brief Title
Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients
Official Title
Paramedian Approach for Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh 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
The aim of this study is to compare the paramedian approach for spinal anesthesia using ultrasound assistance (USAS) versus conventional palpation in morbidly obese patients undergoing elective surgeries.
Detailed Description
Performing spinal anesthesia using a conventional approach can be considerably challenging in obese patients. Multiple needle attempts may lead to a higher incidence of complications (e.g., postdural puncture headache, paresthesia, hematoma, and infection) and increase patient discomfort and dissatisfaction. Therefore, novel techniques are needed to improve the success rate of spinal anesthesia for such patients. There are two puncture approaches for spinal anesthesia: median approach puncture and paramedian approach puncture. Early studies have noted that the success rate of paramedian approach puncture was higher than that of median approach puncture and that it is associated with fewer complications and postoperative complications. A paramedian approach has been shown to improve the success rate of spinal anesthesia, especially in patients who are unable to sit up or those with a degenerative spine condition. The use of ultrasound has been suggested to increase the efficacy of spinal anesthesia. Recently, ultrasound has emerged as a way to facilitate lumbar neuraxial blocks, namely, the ultrasound assistance (USAS) technique. The ultrasound assistance technique is beneficial for lumbar neuraxial anesthesia, improving technique performance by providing reliable anatomical information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Anesthesia, Ultrasound Assistance, Obesity, Morbid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paramedian conventional palpation group
Arm Type
Experimental
Arm Description
Patients in this group underwent conventional landmark guided paramedian spinal anesthetic. The spinal anesthesia will be administered based on conventional landmark-based paramedian approach.
Arm Title
Ultrasound assistance paramedian spinal group
Arm Type
Experimental
Arm Description
This group will have their spinal anesthetic done based on Ultrasound assistance paramedian spinal.
Intervention Type
Procedure
Intervention Name(s)
Paramedian conventional palpation group
Intervention Description
Patients in this group underwent conventional landmark guided paramedian spinal anesthetic. The spinal anesthesia will be administered based on conventional landmark-based paramedian approach.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound assistance paramedian spinal group
Intervention Description
This group will have their spinal anesthetic done based on ultrasound assistance paramedian spinal. Spinal anesthesia with a paramedian approach was performed based on the optimum puncture point, suggested puncture angles, and puncture depth. The suggested puncture angles included the cephalad angle measured by the built-in angle program of the ultrasound and the medial angle measured by a 180° protractor (Deli). The puncture depth, the distance from the skin to the posterior complex, was measured utilizing the ultrasound clipper tool.
Primary Outcome Measure Information:
Title
The rate of successful dural puncture on the first attempt
Description
First-attempt success rate will be recorded
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Total success rate of spinal anesthesia
Description
Successful Dural Puncture Rates for Selected Number of Attempts and Passes in both intervention groups
Time Frame
Intraoperatively
Title
Adverse reactions during puncture
Description
Adverse reactions during puncture as incidence of nerve stimulation
Time Frame
Intraoperatively
Title
Complications after anesthesia
Description
Complications after anesthesia as incidence of low back pain
Time Frame
24 hours Postoperative
Title
Patients' satisfaction after surgery
Description
6- Degree of patient satisfaction will be assessed on a 3-point scale; (1= unsatisfied 2= neither satisfied nor unsatisfied 3= satisfied)
Time Frame
24 hours Postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Both sexes Body mass index (BMI) ≥ 40 kg/m2 Patients undergoing elective surgeries Exclusion Criteria: Rejection of spinal anesthesia History of spinal deformity or spinal surgery Contraindications to spinal anesthesia (infection of the puncture site, coagulation dysfunction, allergy to local anesthesia, insufficient blood volume or abnormal spinal anatomy).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Algyar, MD
Phone
0111645345
Ext
+2
Email
mohammad.algaiar@med.kfs.edu.eg
Facility Information:
Facility Name
Kafr El-Sheikh University Hospitals
City
Kafr Ash Shaykh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Algyar, MSc.
Email
mohammad.algaiar@med.kfs.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This study will be available upon a reasonable request from the corresponding author
IPD Sharing Time Frame
One year after the end of the study

Learn more about this trial

Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients

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