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Completed

NCT Number: NCT03074097

Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

Study groups: 60 patients were included in the study randomly allocated into two groups of 30 patients. Rectus sheath group (RSB): 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. Control group: the patients did not receive any intervention after anaesthesia induction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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

Other names: Plain marcaine

Primary outcomes

  1. cumulative opioid consumption

    Time frame: 24 hours postoperative

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

Secondary outcomes

  1. Numerical rating scale (NRS)

    Time frame: 24 hours postoperative

    evaluate postoperative pain intensity by NRS

  2. time to first anlgesic request

    Time frame: 24 hours postoperative

    the first time receiving IV-PCA bolus injection

  3. serum levels of TNF-α

    Time frame: at 24 hours postoperative

    Proinflamatory cytokines

  4. Serum level of IL-6

    Time frame: at 24 hours postoperative

    Proinflamatory cytokines

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Rectus Sheath Block on Opioid Consumption and Serum Level of TNF-α and IL-6 After Radical Prostatectomy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 8, 2017
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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