NCT03074097

Brief Summary

Good quality of postoperative analgesia would lead to attenuate or prevent the adverse effects on the common functions of the immune system. We compared the effect of epidural analgesia versus rectus sheath block on postoperative pain and proinflammatory cytokines following malignant urological surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 postoperative-pain

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 27, 2017

Last Update Submit

February 21, 2018

Conditions

Postoperative Pain

Keywords

Rectus sheath block, Postoperative pain,TNF alpha and IL-6

Outcome Measures

Primary Outcomes (1)

  • cumulative opioid consumption

    study the effect of RSB on cumulative opioid consumption at 24 hours

    24 hours postoperative

Secondary Outcomes (4)

  • Numerical rating scale (NRS)

    24 hours postoperative

  • time to first anlgesic request

    24 hours postoperative

  • serum levels of TNF-α

    at 24 hours postoperative

  • Serum level of IL-6

    at 24 hours postoperative

Study Arms (2)

Rectus Sheath

ACTIVE COMPARATOR

Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia

Drug: Bupivacaine 0.25%

Control

NO INTERVENTION

Control group: the patients did not receive any intervention after anaesthesia induction.

Interventions

Bupivacaine 0.25%DRUG

Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia

Also known as: Plain marcaine
Rectus Sheath

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients their age over 40 years, classified ASA I, II or III, undergoing radical resection of cancer prostate, through midline abdominal incision under general anaesthesia.

You may not qualify if:

  • Contraindications to rectus sheath block as patient refusal, coagulopathy, local infection and allergy to bupivacaine. Planned transverse or oblique abdominal incision, extensive existing midline abdominal scarring or pre-existing chronic abdominal pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

Related Publications (1)

  • Hong JY, Lim KT. Effect of preemptive epidural analgesia on cytokine response and postoperative pain in laparoscopic radical hysterectomy for cervical cancer. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):44-51. doi: 10.1016/j.rapm.2007.07.010.

    PMID: 18155056BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Waleed S Farrag

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of anesthesia and ICU

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 8, 2017

Study Start

March 5, 2015

Primary Completion

February 1, 2016

Study Completion

April 28, 2016

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

EG(1)