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Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Epidural catheter
rectus sheath catheter
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring rectus sheath catheter, pain following laparotomys.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients at age rang from 18 to 60 undergoing laparotomy
  • patients ASA1,2 physical status

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculty of Medicine Menoufia University
  • Menoufia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Epidural Group

Rectus sheath catheter Group

Arm Description

epidural catheter inserted pre induction

rectus sheath catheter inserted by the surgeon at the end of surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Side effects
Occurrence any side effects Time of return of bowel movement. Time of discharage. Amount of analgesia used
Total of analgesic consumption
total consumption of naluphine and paracetamol pre milligram

Full Information

First Posted
February 3, 2021
Last Updated
June 22, 2022
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04755725
Brief Title
Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain
Official Title
Comparison Between Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain Following Laparotomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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. In both groups we activated with10 ml bupivacain25% before patient recovery then 10 ml bupivacain.125% each 6 hours. If patient still in pain 1gm perflgan injected. If patient still in pain 10 mg nalufine for 70 kg patient injected. we will record pulse, blood pressure and visual analogue scale at 0,6,12,24 and 36 hours postoperative. Also Occurrence of nausea and vomiting, Time of return of bowel movement, Time of discharage and amount of analgesia used will be recorded. Results, discution will be later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
rectus sheath catheter, pain following laparotomys.

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural Group
Arm Type
Active Comparator
Arm Description
epidural catheter inserted pre induction
Arm Title
Rectus sheath catheter Group
Arm Type
Active Comparator
Arm Description
rectus sheath catheter inserted by the surgeon at the end of surgery
Intervention Type
Device
Intervention Name(s)
Epidural catheter
Intervention Description
epidural catheter inserted pre induction
Intervention Type
Device
Intervention Name(s)
rectus sheath catheter
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative pain relief
Description
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
Time Frame
36hours
Secondary Outcome Measure Information:
Title
Side effects
Description
Occurrence any side effects Time of return of bowel movement. Time of discharage. Amount of analgesia used
Time Frame
36hours
Title
Total of analgesic consumption
Description
total consumption of naluphine and paracetamol pre milligram
Time Frame
36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients at age rang from 18 to 60 undergoing laparotomy patients ASA1,2 physical status Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rabab M habeeb, Lecture
Phone
+201001970973
Email
rabab_habeeb@med.menofia.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Raouf, Professor
Organizational Affiliation
Menofia University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine Menoufia University
City
Cairo
State/Province
Governorate
ZIP/Postal Code
32511
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rabab M habeeb, Dr
Phone
01001970973
Email
rabab_habeeb@med.menofia.edu.eg
First Name & Middle Initial & Last Name & Degree
Asmaa M Hamza
Facility Name
Menoufia University
City
Cairo
State/Province
Governorate
ZIP/Postal Code
32817
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rabab habeeb
Phone
01001970973

12. IPD Sharing Statement

Plan to Share IPD
No

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Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain

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