NCT07047469

Brief Summary

This study aims to compare between the two methods (midline and paramedian approach of spinal anesthesia guided by ultrasound) by the number of needle passes required to successful dural puncture.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 24, 2025

Last Update Submit

June 24, 2025

Conditions

Anesthesia; Functional

Outcome Measures

Primary Outcomes (1)

  • The severity of back pain in patients that will receive spinal anesthesia by median versus paramedian approach

    pain measurement by numerical rating scale (NRS)

    24 hours, 72 hours, and 1 week after spinal anesthesia.

Study Arms (2)

Group (1): spinal anesthesia with median approach

ACTIVE COMPARATOR

patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques

Procedure: Group (1): spinal anesthesia with median approach

Group (2): spinal anesthesia with paramedian approach

ACTIVE COMPARATOR

patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques

Procedure: Group (2): spinal anesthesia with paramedian approach

Interventions

Group (1): spinal anesthesia with median approachPROCEDURE

patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques

Group (1): spinal anesthesia with median approach
Group (2): spinal anesthesia with paramedian approachPROCEDURE

patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques

Group (2): spinal anesthesia with paramedian approach

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will perform orthopedic surgery
  • Physical state I or II according to ASA classification
  • Age between (18 - 50 )
  • Body mass index less than 30

You may not qualify if:

  • Patient refusal .
  • Local infection at the puncture site .
  • Allergy to any of the drugs to be administrated .
  • Old age patients
  • Obese patients
  • Previous spinal surgery .
  • Spinal stenosis .
  • Multiple sclerosis .
  • Coagulopathy.
  • Hypovolemia .
  • Systemic infection .
  • Aortic stenosis .
  • Spina bifida and back deformity .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Zeng W, Shi Y, Zheng Q, Du S. Ultrasound-assisted modified paramedian technique for spinal anesthesia in elderly. BMC Anesthesiol. 2022 Jul 30;22(1):242. doi: 10.1186/s12871-022-01751-0.

    PMID: 35907825BACKGROUND

  • Singh B, Sohal AS, Singh I, Goyal S, Kaur P, Attri JP. Incidence of Postspinal Headache and Low Backache Following the Median and Paramedian Approaches in Spinal Anesthesia. Anesth Essays Res. 2018 Jan-Mar;12(1):186-189. doi: 10.4103/aer.AER_139_17.

    PMID: 29628579BACKGROUND

  • Wilson JM, Farley KX, Erens GA, Guild GN 3rd. General vs Spinal Anesthesia for Revision Total Knee Arthroplasty: Do Complication Rates Differ? J Arthroplasty. 2019 Jul;34(7):1417-1422. doi: 10.1016/j.arth.2019.03.048. Epub 2019 Mar 28.

    PMID: 31005435BACKGROUND

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Central Study Contacts

Areej M Abd Elkader, Resident

CONTACT

01288811379Mareej22@yahoo.com

Ahmed E Abd Elrahman, Professor

CONTACT

01118011611

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
Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start

June 13, 2025

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

July 2, 2025

Record last verified: 2025-06

Locations

EG(1)