Postoperative pain MedDRA version: 15.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Chircocaine
Product Name: Levobupivacaine
Pharmaceutical Form: Solution for injection
Trade Name: Sublimaze
Product Name: Fentanyl
Pharmaceutical Form: Solution for injection
Sponsors
Dept of Anaesthesia, University College Hospital, Galway
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Adults aged 18 to 80 years old Presenting for elective retropubic prostatectomy Written Informed Consent ASA Grade 1 to 3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50 ;Inclusion criteria: Adults aged 18 to 80 years old Presenting for elective retropubic prostatectomy Written Informed Consent ASA Grade 1 to 3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Patient refusal Outside Age Range Contraindication to neuraxial anaesthesia Allergy to Levobupivacaine, morphine, paracetamol, diclofenac sodium Skin lesions/infection at site of injection Renal or other organ dysfunction Sepsis Psychosis ;Exclusion criteria: Patient refusal Outside Age Range Contraindication to neuraxial anaesthesia Allergy to Levobupivacaine, morphine, paracetamol, diclofenac sodium Skin lesions/infection at site of injection Renal or other organ dysfunction Sepsis Psychosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Morphine used in 72 hours Levobupivacaine used in 72 hours Sedation Postoperative Nausea and Vomiting Itch Hemodynamic data Patient Satisfaction Systemic absorption of Levobupivacaine Effect on the stress response to surgery ;Main Objective: A promising alternative approach to the provision of postoperative analgesia following abdominal incision is to block the entire sensory nerve supply to the anterior abdominal wall. We have recently described the Transversus Abdominis Plane (TAP) Block, a reliable approach to the blockade of the neural afferents to the anterior abdominal wall. In this study, we aim to compare the analgesic efficacy of TAP block to epidural blockade in the first 72 postoperative hours by monitoring pain score, in patients undergoing retropubic prostatectomy, in a randomized controlled single blind clinical trial.;Primary end point(s): Severity of Postoperative Pain [VAS and Categorical pain Scales]. ;Timepoint(s) of evaluation of this end point: Postoperatively at 1hr, 2hr, 4hr, 6hr, 12hr, 24hr, 48hr, 72hr.;Secondary Objective: Morphine used in 72 hours Levobupivacaine used in 72 hours Sedation Postoperative Nausea and Vomiting Itch Hemodynamic data Patient Satisfaction Systemic absorption of Levobupivacaine Effect on the stress response to surgery ;Main Objective: A promising alternative approach to the provision of postoperative analgesia following abdominal incision is to block the entire sensory nerve supply to the anterior abdominal wall. We have recently described the Transversus Abdominis Plane (TAP) Block, a reliable approach to the blockade of the neural afferents to the anterior abdominal wall. In this study, we aim to compare the analgesic efficacy of TAP block to epidural blockade in the first 72 postoperative hours by monitoring pain score, in patients undergoing retropubic prostatectomy, in a randomized controlled single blind clinical trial.;Primary end point(s): Severity of Postoperative Pain [VAS and C | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Morphine used in 72 hours Levobupivacaine used in 72 hours Sedation Postoperative Nausea, Vomiting, Itch Hemodynamic data Patient Satisfaction Systemic absorption of Levobupivacaine Effect on the stress response to surgery;Timepoint(s) of evaluation of this end point: Postoperatively at 1hr, 2hr, 4hr, 6hr, 12hr, 24hr, 48hr, 72hr.;Secondary end point(s): Morphine used in 72 hours Levobupivacaine used in 72 hours Sedation Postoperative Nausea, Vomiting, Itch Hemodynamic data Patient Satisfaction Systemic absorption of Levobupivacaine Effect on the stress response to surgery;Timepoint(s) of evaluation of this end point: Postoperatively at 1hr, 2hr, 4hr, 6hr, 12hr, 24hr, 48hr, 72hr. | — |
Countries
Ireland
Contacts
Public Contact; ;
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Outcome results
None listed