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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Device: Epidural catheter; Device: rectus sheath catheter

• Registration Number: NCT04755725
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-16
• Study Start: 2022-01-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Group	Epidural catheter	epidural catheter inserted pre induction
Rectus sheath catheter Group	rectus sheath catheter	rectus sheath catheter inserted by the surgeon at the end of surgery

Primary Outcome Measures

Name	Time	Method
Postoperative pain relief	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 Outcome Measures

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

Trial Locations

Locations (2)

Faculty of Medicine Menoufia University; 🇪🇬 Cairo, Governorate, Egypt

Menoufia University; 🇪🇬 Cairo, Governorate, Egypt