Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain
Comparison Between Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain Following Laparotomy
1 other identifier
interventional
120
1 country
2
Brief Summary
One hundred and twenty patients at age range from 18 to 60 undergoing laparotomy was enrolled in this study. Patients were randomly assigned to two groups 60 in epidural group and the other 60 patients in rectus catheter group. epidural catheter inserted pre induction but rectus sheath catheter inserted by the surgeon at the end of surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Jan 2022
Typical duration for not_applicable postoperative-pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedStudy Start
First participant enrolled
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedDecember 19, 2023
December 1, 2023
1.7 years
February 3, 2021
December 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative pain relief
Measured by Visual Analogue Scale (VAS) pain measurement scale divided from 0 to 10 where 0 is no pain and10 worst pain can be imagined
36hours
Secondary Outcomes (2)
Side effects
36hours
Total of analgesic consumption
36 hours
Study Arms (2)
Epidural Group
ACTIVE COMPARATORepidural catheter inserted pre induction
Rectus sheath catheter Group
ACTIVE COMPARATORrectus sheath catheter inserted by the surgeon at the end of surgery
Interventions
The surgeon will place one hand inside the abdomen and with the other hand inserted the Tuohy needle through the skin and fascia. The surgeon will feel when the needle tip is just superfacial to interface between the peritoneum and muscle layer and avoid penetration of inferior epigastric artery. The procedure will be repeated on the contralateral
Eligibility Criteria
You may qualify if:
- patients at age rang from 18 to 60 undergoing laparotomy
- patients ASA1,2 physical status
You may not qualify if:
- any known coagulopathy
- morbid obesity
- kyphosis or scoliosis
- those with known sensitivity to local anesthetic drugs
- lack of cooperation and inability to understand or perform verbal or physical assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of Medicine Menoufia University
Cairo, Governorate, 32511, Egypt
Menoufia University
Cairo, Governorate, 32817, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed M Raouf, Professor
Menoufia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
February 3, 2021
First Posted
February 16, 2021
Study Start
January 10, 2022
Primary Completion
October 1, 2023
Study Completion
November 1, 2023
Last Updated
December 19, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share