Analgesic efficacy of intrawound local anesthetic and steroid

Efficacy of intralesional infusion of local anesthetics in patients undergoing major abdominal surgery: a randomized double-blind trial. - PT-SM-13-YR

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005265-13-IT

Enrollment

120

Registered

2013-03-22

Start date

2013-04-26

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoning major abdominal surgery requiring postoperative analgesic therapy, not hospitalized in intensive care and not using drugs by neuraxial analgesia MedDRA version: 15.1 Level: PT Classification code 10068093 Term: Gastrointestinal surgery System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Naropina Product Name: Naropina Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intralesional

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and females 18-75 years old scheduled to use PCA with morphine for postoperative pain control - HIV-negative - Classification American Society of Anesthesiologists (ASA) I: without systemic disease - Classification ASA II or III (moderate systemic disease or severe systemic disease that limits activity without disability) - Scheduled for major abdominal and urologic surgery (no emergency surgery) - Signed informed consent - No severe hepatic or renal impairment (cholinesterase =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - regular use of opioid analgesics; - History of abuse of drugs and / or alcohol; - Postoperative hospitalization in intensive care with sedation and / or mechanical ventilation; - severe renal impairment (creatinine> 2 g / dl, creatinine clearance 2, PTT> 44 sec); - Platelet count less than 100.000/mm3; - BMI> 30; - immunodepression (WBC<5.000) - Allergy to study drugs.

Design outcomes

Primary

Measure	Time frame
Main Objective: Verify if intralesional infusion of local anesthetic and steroids has a greater analgesic efficacy compared to the control group during the first 7 days after surgery, assessed by reduction of analgesics consumption ;Secondary Objective: -Safety evaluation: side effects of whole treatment (systemic and local drugs), also at 1 and 3 months -Reduction of pain values within 7 days following surgery (assessed by rate Numeric Rating Scale - scale from 0 to 10); -Reduction in the incidence of morphine side effects; -Reduction in the incidence of persistent post-surgical pain (estimated at 1 and 3 months) - Analysis of the inflammatory response and genetic patterns corresponding to pain ;Primary end point(s): Verify if intralesional infusion of local anesthetic and steroids has a greater analgesic efficacy compared to the control group during the first 7 days after surgery, assessed by reduction of analgesics consumption ;Timepoint(s) of evaluation of this end point: 7 days after surgery	—

Measure

Time frame

Main Objective: Verify if intralesional infusion of local anesthetic and steroids has a greater analgesic efficacy compared to the control group during the first 7 days after surgery, assessed by reduction of analgesics consumption ;Secondary Objective: -Safety evaluation: side effects of whole treatment (systemic and local drugs), also at 1 and 3 months -Reduction of pain values within 7 days following surgery (assessed by rate Numeric Rating Scale - scale from 0 to 10); -Reduction in the incidence of morphine side effects; -Reduction in the incidence of persistent post-surgical pain (estimated at 1 and 3 months) - Analysis of the inflammatory response and genetic patterns corresponding to pain ;Primary end point(s): Verify if intralesional infusion of local anesthetic and steroids has a greater analgesic efficacy compared to the control group during the first 7 days after surgery, assessed by reduction of analgesics consumption ;Timepoint(s) of evaluation of this end point: 7 days after surgery

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Secondary

Measure	Time frame
Secondary end point(s): - Safety evaluation: side effects of whole treatment (systemic and local drugs), also at 1 and 3 months - Reduction of pain values within 7 days following surgery (assessed by rate Numeric Rating Scale - scale from 0 to 10); - Reduction in the incidence of morphine side effects; - Reduction in the incidence of persistent post-surgical pain (estimated at 1 and 3 months) - Analysis of the inflammatory response and genetic patterns corresponding to pain ;Timepoint(s) of evaluation of this end point: - Safety evaluation: at 1 and 3 months - Reduction of pain: within 7 days following surgery - Reduction in the incidence of persistent post-surgical pain: at 1 and 3 months	—

Measure

Time frame

Secondary end point(s): - Safety evaluation: side effects of whole treatment (systemic and local drugs), also at 1 and 3 months - Reduction of pain values within 7 days following surgery (assessed by rate Numeric Rating Scale - scale from 0 to 10); - Reduction in the incidence of morphine side effects; - Reduction in the incidence of persistent post-surgical pain (estimated at 1 and 3 months) - Analysis of the inflammatory response and genetic patterns corresponding to pain ;Timepoint(s) of evaluation of this end point: - Safety evaluation: at 1 and 3 months - Reduction of pain: within 7 days following surgery - Reduction in the incidence of persistent post-surgical pain: at 1 and 3 months

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Countries

Italy

Contacts

Public ContactTerapia del dolore

Fondazione IRCCS Policlinico San Matteo

m.allegri@smatteo.pv.it+390382502627

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026