NCT06684548

Brief Summary

Spinal anesthesia is a straightforward and reliable technique frequently employed in lower body surgeries, achieving adequate surgical conditions through the injection of a small amount of local anesthetic (LA) into the intrathecal space . One advantage of spinal anesthesia over general anesthesia is reduced exposure to potentially depressant drugs . However, inadequate spinal spread can result in pain and discomfort for patients and complicate surgical procedures . Consequently, anesthesiologists encounter the challenge of attaining the proper spread of spinal anesthesia for subumbilical herniorrhaphy due to individual anthropometric variations . Approximately 25 factors have been identified that affect the spread of spinal anesthesia in the subarachnoid space for a given dose of LA . Variables that are both practically obtainable and predictive of spinal anesthesia spread can aid anesthesiologists in anticipating the extent of the block. Among the most studied factors are patient characteristics, injection techniques, patient posture, and the baricity of the LA . Research has examined various patient variables affecting spinal anesthesia spread, including age , weight , height , gender, patient position, BMI , vertebral column length (VCL), and abdominal circumference . Body morphometrics such as the hip-shoulder width ratio (HSWR) have garnered attention for their potential impact on the distribution of anesthetic agents within the intrathecal space . Despite the well-established influence of factors like age, weight, and spinal anatomy, the specific role of HSWR in the outcomes of intrathecal anesthesia remains underexplored this study aim to To evaluate the effect of hip/shoulder-width ratio (HSWR) on sensory blockade level after intrathecal anesthesia for adult patients undergoing subumblical herniorraphy

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Dec 2025

Status
not yet 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 Progress40%
Dec 2025Jan 2027

First Submitted

Initial submission to the registry

November 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 9, 2024

Last Update Submit

November 9, 2024

Conditions

Keywords

hip/shoulder-width ratiosub umblical herniorrhaphy

Outcome Measures

Primary Outcomes (1)

  • the sensory blockade level in patients undergoing intrathecal anesthesia for subumbilical herniorrhaphy.

    baseline

Interventions

the effect of hip/shoulder-width ratio on sensory blockade level in patients undergoing intrathecal anesthesia for subumbilical herniorrhaphy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients subjected to subumblical herniorraphy

You may qualify if:

  • Age 20 - 50 years old
  • Both sexes
  • Patients who are in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)
  • Elective subumblical herniorraphy under intrathecal anesthesia

You may not qualify if:

  • Patient refusal
  • Patients have a contraindication for regional anesthesia, e.g. coagulopathy.
  • Failed or unsatisfactory intrathecal block.
  • Patients have a central nervous system disease (mental retardation, non-cooperated speech disorder, or psychiatric disease).
  • Patients who are under 150 cm or over 185 cm in height, or BMI \>40.
  • Patients have experienced an operation lasting more than 2 h.
  • Patients with known hypersensitivity to amide local anesthetics.
  • Local injection site infection or spinal deformity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Ngaka TC, Coetzee JF, Dyer RA. The Influence of Body Mass Index on Sensorimotor Block and Vasopressor Requirement During Spinal Anesthesia for Elective Cesarean Delivery. Anesth Analg. 2016 Dec;123(6):1527-1534. doi: 10.1213/ANE.0000000000001568.

    PMID: 27870737BACKGROUND
  • Fu F, Xiao F, Chen W, Yang M, Zhou Y, Ngan Kee WD, Chen X. A randomised double-blind dose-response study of weight-adjusted infusions of norepinephrine for preventing hypotension during combined spinal-epidural anaesthesia for Caesarean delivery. Br J Anaesth. 2020 Mar;124(3):e108-e114. doi: 10.1016/j.bja.2019.12.019. Epub 2020 Jan 17.

    PMID: 31959386BACKGROUND
  • Chen M, Chen C, Ke Q. The effect of age on the median effective dose (ED50) of intrathecally administered plain bupivacaine for motor block. Anesth Analg. 2014 Apr;118(4):863-8. doi: 10.1213/ANE.0000000000000147.

    PMID: 24651241BACKGROUND
  • Zhou QH, Xiao WP, Shen YY. Abdominal girth, vertebral column length, and spread of spinal anesthesia in 30 minutes after plain bupivacaine 5 mg/mL. Anesth Analg. 2014 Jul;119(1):203-206. doi: 10.1213/ANE.0000000000000199.

    PMID: 24806139BACKGROUND
  • Adesope OA, Einhorn LM, Olufolabi AJ, Cooter M, Habib AS. The impact of gestational age and fetal weight on the risk of failure of spinal anesthesia for cesarean delivery. Int J Obstet Anesth. 2016 May;26:8-14. doi: 10.1016/j.ijoa.2016.01.007. Epub 2016 Feb 2.

    PMID: 27020240BACKGROUND
  • Agegnehu AF, Gebregzi AH, Endalew NS. Review of evidences for management of rapid sequence spinal anesthesia for category one cesarean section, in resource limiting setting. Int J Surg Open. 2020;26:101-105. doi: 10.1016/j.ijso.2020.08.013. Epub 2020 Sep 3.

    PMID: 34568612BACKGROUND
  • Shivashankar A, Rajappa GC, Sudarshan S, Madhu MM, Rao R. Evaluation of Effect of Hip/Shoulder-Width Ratio on the Sensory Level of Spinal Anesthesia - A Prospective Observational Study. Anesth Essays Res. 2022 Jan-Mar;16(1):80-83. doi: 10.4103/aer.aer_146_21. Epub 2022 Jun 27.

    PMID: 36249129BACKGROUND

Central Study Contacts

Amr Fouad, resident doctors

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctors at Anesthesia, Intensive Care and Pain Management

Study Record Dates

First Submitted

November 9, 2024

First Posted

November 12, 2024

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

November 12, 2024

Record last verified: 2024-11