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

NCT ID: NCT04755725

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-11-01

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Keywords

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rectus sheath catheter, pain following laparotomys.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Epidural Group

epidural catheter inserted pre induction

Group Type ACTIVE_COMPARATOR

Epidural catheter

Intervention Type DEVICE

epidural catheter inserted pre induction

Rectus sheath catheter Group

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

Group Type ACTIVE_COMPARATOR

rectus sheath catheter

Intervention Type 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

Interventions

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Epidural catheter

epidural catheter inserted pre induction

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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rabab Mohammad habeeb

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M Raouf, Professor

Role: STUDY_CHAIR

Menoufia University

Locations

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Faculty of Medicine Menoufia University

Cairo, Governorate, Egypt

Site Status

Menoufia University

Cairo, Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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5/2017ANET

Identifier Type: -

Identifier Source: org_study_id