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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755725
• Other study ID #: 5/2017ANET
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: December 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Epidural catheter
epidural catheter inserted pre induction
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Menoufia University	Cairo	Governorate
Egypt	Menoufia University	Cairo	Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects	Occurrence any side effects Time of return of bowel movement. Time of discharage. Amount of analgesia used	36hours
Secondary	Total of analgesic consumption	total consumption of naluphine and paracetamol pre milligram	36 hours