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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Epidural catheter; Device: rectus sheath catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: rabab M habeeb, Lecture; Phone Number: +201001970973; Email: rabab_habeeb@med.menofia.edu.eg

Study Locations

• Egypt
  • Governorate
    • Cairo, Governorate, Egypt, 32511
      • Faculty of Medicine Menoufia University
    • Cairo, Governorate, Egypt, 32817
      • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural Group; epidural catheter inserted pre induction	Device: Epidural catheter; epidural catheter inserted pre induction
Active Comparator: Rectus sheath catheter Group; rectus sheath catheter inserted by the surgeon at the end of surgery	Device: rectus sheath catheter; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Occurrence any side effects Time of return of bowel movement. Time of discharage. Amount of analgesia used	36hours
Total of analgesic consumption	total consumption of naluphine and paracetamol pre milligram	36 hours

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: Ahmed M Raouf, Professor, Menofia University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: rectus sheath catheter, pain following laparotomys.
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 5/2017ANET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No