Impact of Epidural Anesthesia on Low Back Function

NCT04759963 | Completed

• 1 other identifier: South Valley University
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

Back pain is a common complication after the use of epidural anesthesia in obstetric and non-obstetric surgeries and occurs in 30-45% of cases (Brown, 2005). Certain psychological problems such as depression or unhappiness due to loss of employment may prolong the episode of low back pain (Miller, 2012). According to Egyptian Institution of Health Metrics and Evaluation (IHME), Low Back Pain is the first cause of disability in Egypt from 2007 to 2017. So, this study will investigate if midline approach of obstetric epidural anaesthesia will be a relative risk for subacute low back mechanical functions as a new way to examine if this type of anaesthesia is involved in the presence of subacute negative effects on the mechanical function of low back or not (to resolve the controversy).

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (1)

• Subacute Low Back Pain intensity

  Subacute Low Back Pain intensity is assessed by Visual Analogue scale: Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain."

  assessment will be done at 6 weeks after the use of anaesthesia during Cesarean section

Other Outcomes (1)

• Low Back functional ability

  assessment will be done at 6 weeks after the use of anaesthesia during Cesarean section

Study Arms (4)

Group A

follow up for 6 women who gave birth through a cesarean delivery with Midline approach epidural anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI).

Group B

follow up for 13 women who gave birth through a cesarean delivery with Midline approach spinal anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI).

Group C

follow up for 7 women who gave birth through a cesarean delivery with general anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI).

Group D

follow up for 12 women who are the control group (who did not experience any pregnancy or anesthesia. They will perform all assessment procedures: Visual analog scale (VAS) and Oswestry Disability Index (ODI).

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Primiparous women or Multiparous who did not receive anaesthesia for at least one year prior to the last delivery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

45 women were enrolled in this study with a 20% rate loss of follow-up (i.e. we need at least 38 participants to complete the study). They were selected from the SVU Teaching Hospitals. The Participants were classified into 4 groups: - Group (A): This group included 6 women. They gave birth through a cesarean delivery using Midline approach epidural anesthesia, Group (B): This group included 13 women. They gave birth through a cesarean delivery using Midline approach spinal anesthesia Group (C): This group included 7 women. They gave birth through a cesarean delivery using general anesthesia. Group (D): This group included 12 women. who are the control group,

You may qualify if:

• All women gave birth through a cesarean delivery.
• Their ages will range from 18 to 35 years.
• All participants will have body mass index (BMI) not more than 30.
• All participants will be assessed after 6weeks postnatal.
• All participants will be able to continue all assessment procedures.

You may not qualify if:

• Women who delivered through vaginal delivery.
• Women who delivered through cesarean delivery but the used anesthetic technique was the paramedian approach of epidural anesthesia.
• Women who have any non-myofascial low back dysfunctions.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (2)

Faculty of Physical Therapy - SVU

Cairo, 11672, Egypt

Location

Faculty of physical therapy, South Valley University

Cairo, 11672, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed GA Ali, Msc

  South Valley University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: February 18, 2021
• Study Start: May 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: September 26, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

EG (2)