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CompletedNCT04755725Updated Dec 19, 2023

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

An interventional study of Epidural catheter and rectus sheath catheter in Postoperative Pain, sponsored by Menoufia University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by Menoufia University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Pain

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Keywords

  • rectus sheath catheter, pain following laparotomys.
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 120 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Epidural Group

    epidural catheter inserted pre induction

    Device: Epidural catheter

  • Active comparator
    Rectus sheath catheter Group

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

    Device: rectus sheath catheter

Interventions

  • DeviceEpidural catheter

    epidural catheter inserted pre induction

  • Devicerectus 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

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What researchers measure

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

    Time frame: 36hours

Secondary outcomes

  1. Side effects

    Occurrence any side effects Time of return of bowel movement. Time of discharage. Amount of analgesia used

    Time frame: 36hours

  2. Total of analgesic consumption

    total consumption of naluphine and paracetamol pre milligram

    Time frame: 36 hours

07

Study locations

2 sites
  • Faculty of Medicine Menoufia University
    Cairo, Governorate 32511, Egypt
  • Menoufia University
    Cairo, Governorate 32817, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04755725
Lead sponsor
Menoufia University
Responsible party
rabab Mohammad habeeb (principal investigator, Menoufia University) — Principal investigator
First posted
Feb 16, 2021
Start date
Jan 10, 2022
Primary completion
Oct 1, 2023
Completion
Nov 1, 2023
Last update
Dec 19, 2023

Study contacts

Ahmed M Raouf, Professor
study chair · Menoufia University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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