Assessment and Prevention of Acute Post-herniotomy Pain

Hernia Clinical Trial

— PTSM04APHP  

Official title:

Randomized, Prospective Study of the Assessment, Prevention and Management of Acute Post-herniotomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345162
• Other study ID #: 2009-011856-23
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2011
• Last updated: May 21, 2014
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2014
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two different therapeutical protocols per os: ketorolac versus association of acetaminophene+tramadol.

Description:

Persistent post-herniotomy pain (PPP) affects everyday activities in 5-10% of patients. Even brief intervals of acute pain can induce long-term neuronal remodeling and sensitization, chronic pain and lasting psychological distress. Chronic pain may be caused by intense acute PPP, intraoperative nerve injury and/or ongoing inflammation or mesh response with subsequence damage to nerve structures. The aim of our study is to analyze analgesic efficacy, safety and prevention of persistent postsurgical pain of two different pharmacological strategies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males and females over 18 years, under 80 years, scheduled for elective herniotomy

• Classification American Society of Anesthesiologists (ASA) I: without systemic disease

• Classification ASA II or III (mild systemic disease or severe systemic disease that limits the activity without invalidity).

• Patients with hernia typ 2, 3a, 3b (classification NYHUS (1993))

• Signed informed consent

Exclusion Criteria:

• ASA III, IV

• Emergency surgery

• Recovery in intensive care unit after surgery

• habitual opioid consumption

• NSADs allergy

• cognitive or mental alterations

• coagulopathy

• piastrinemia < 100.000/mm3

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia

Intervention

Drug:
• Ketorolac postoperative
Ketorolac 10mg 1cp x 3/die
• postoperative Patrol
acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die
• intraoperative analgesia
ketorolac 30 mg iv
• intraoperative analgesia
Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo	Pavia	Lomabardy
Italy	Ospedale di Circolo e Fondazione Macchi	Varese	Lombardy

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo	University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic Efficacy	percentage of patients with NRS=4. (NRS=numeric rating scale; o quantify pain from0=no pain to 10=worst pain possible).; NRS=4 is cosidered as suboptimal pain control worth to be treated with adjunctive analgesics. We therefore condidered the difference in percentage of patients experiencing not optimal pain control in the two groups to understand, if any, the difference in analgesic efficacy between the two drugs.	4 days postherniotomy	No
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded.; Assessment of any difference between the two groups.	4 days postherniotoy	Yes
Secondary	Difference in Recovering Daily Activity	Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)	4 days after surgical procedure	No
Secondary	Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications	Assessment of the recurrence of surgical complications. Evaluation of all the patients after 5 days by clinical evaluation. After 1 and 3 month in the patients who refer pain.; Assessment of any difference between the two groups.	4 days postherniotomy	Yes
Secondary	Development of Persistent Postoperative Pain	Assessment of pain prevalence and presentation of persistant postoperative pain. Evaluation of all the patients after 1 and 3 months by phone call and with clinical re-evaluation in all patients who referred pain.	Up to 3 months	No