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NCT Number: NCT04755725

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Menoufia University, Cairo, Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidural catheter

Device

epidural catheter inserted pre induction

rectus sheath catheter

Device

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 outcomes

  1. Postoperative pain relief

    Time frame: 36hours

    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 outcomes

  1. Side effects

    Time frame: 36hours

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

  2. Total of analgesic consumption

    Time frame: 36 hours

    total consumption of naluphine and paracetamol pre milligram

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Comparison Between Epidural Catheter and Surgically Implanted Rectus Sheath Catheter in Management of Postoperative Pain Following Laparotomy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2021
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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