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

NCT05240846 | Unknown

• 1 other identifier: MKSU 48-1-31
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Ultrasound Assistance; Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• The rate of successful dural puncture on the first attempt

  First-attempt success rate will be recorded

  Intraoperatively

Secondary Outcomes (4)

• Total success rate of spinal anesthesia

  Intraoperatively

• Adverse reactions during puncture

  Intraoperatively

• Complications after anesthesia

  24 hours Postoperative

• Patients' satisfaction after surgery

  24 hours Postoperative

Study Arms (2)

Paramedian conventional palpation group

EXPERIMENTAL

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

Procedure: Paramedian conventional palpation group

Ultrasound assistance paramedian spinal group

EXPERIMENTAL

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

Procedure: Ultrasound assistance paramedian spinal group

Interventions

Paramedian conventional palpation group PROCEDURE

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

Paramedian conventional palpation group

Ultrasound assistance paramedian spinal group PROCEDURE

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.

Ultrasound assistance paramedian spinal group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr El-Sheikh University Hospitals

Kafr ash Shaykh, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohammad Algyar, MD

CONTACT

0111645345; mohammad.algaiar@med.kfs.edu.eg

Study Design

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

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: February 23, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)