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

Sponsor

Menoufia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04755725

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Device: Epidural catheter Device: rectus sheath catheter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Menoufia University	Cairo	Governorate	Egypt	32511
2	Menoufia University	Cairo	Governorate	Egypt	32817

Sponsors and Collaborators

Menoufia University

Investigators

Study Chair: Ahmed M Raouf, Professor, Menofia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

rabab Mohammad habeeb, principal investigator, Menoufia University

ClinicalTrials.gov Identifier:

NCT04755725

Other Study ID Numbers:

5/2017ANET

First Posted:

Feb 16, 2021

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by rabab Mohammad habeeb, principal investigator, Menoufia University

rectus sheath catheter, pain following laparotomys.

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jun 23, 2022