Comparison of Incidence of Back Pain

Sponsor

Keimyung University Dongsan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05082220

Collaborator

(none)

Enrollment

Location

Arms

5.6

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Paramedian and midline approach are two methods for the epidural entry. After the procedure of epidural injection. there are patients complaing dull nature back pain. This study was designed to comapre the incidence of back pain after performance of thoracic epidural catheterization with paramedian and midline approach.

Condition or Disease	Intervention/Treatment	Phase
Back Pain	Procedure: epidural catheterization	N/A

Detailed Description

In previous studies, occurrence of back apin after epdiural or spinal anesthesia has been reported to have similar incidences with back pain after general anesthesia. The characteristics of this back pain is mild, localized in back pain without radiation, and improved within a few days. The risk factor for this back pain is lithotomy position, multiple attempt for regional block, operation more than 2.5 hour, BMI >32 and previous history of back pain. The proposed mechanism for this back pain is rupture of ligament or tendon during advance of needle, local hemorraghe due to friction with a bone, immobility of spine, relaxation of paraspinal muscle, and streching or straining of joint capsule.

Paramedian and midline approach are two methods for the epidural entry. When the midline approach is performed, the needle is inserted at the corresponding level of spinous process lower edge. The needle penetrates supraspinous ligaments, interspinous ligaments and ligamentum flavum sequentially. During paramedian approach, the needle is inserted 1cm below and 1 cm lateral to the spinous process. In constrast to midline approach, this method does not penetrate supraspinous and interspinous ligaments.

There is no study showing the differences of incidenece of back pain with midline or paramedian approach.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Incidence of Postoperative Back Pain Between Different Thoracic Epidural Approach Method

Actual Study Start Date :

May 12, 2021

Anticipated Primary Completion Date :

Oct 25, 2021

Anticipated Study Completion Date :

Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: midline group epidural catheterization with midline appraoch	Procedure: epidural catheterization epidural catheterization using midline or paramedian approach
Active Comparator: paramedian group epidural catheterization with paramedian approach	Procedure: epidural catheterization epidural catheterization using midline or paramedian approach

Arm

Intervention/Treatment

Placebo Comparator: midline group

epidural catheterization with midline appraoch

Procedure: epidural catheterization

epidural catheterization using midline or paramedian approach

Active Comparator: paramedian group

epidural catheterization with paramedian approach

Procedure: epidural catheterization

epidural catheterization using midline or paramedian approach

Outcome Measures

Primary Outcome Measures

Change from baseline back pain numeric rating scale at 1 month [Baseline, 1 month after operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

liver lobectomy
gastrectomy
lung lobectomy
esophagectomy

Exclusion Criteria:

allergy to local anesthetics or contrast medium
pregnancy
infection
spine deformity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hong ji HEE	Daegu		Korea, Republic of	42601

Sponsors and Collaborators

Keimyung University Dongsan Medical Center

Investigators

Principal Investigator: Ji H Hong, Keimyung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center

ClinicalTrials.gov Identifier:

NCT05082220

Other Study ID Numbers:

2021-03-061

First Posted:

Oct 18, 2021

Last Update Posted:

Oct 18, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Study Results

No Results Posted as of Oct 18, 2021