Assessment and Prevention of Acute Post-herniotomy Pain

NCT01345162 | Completed Phase 4 Results DMC

• 1 other identifier: 2009-011856-23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hernia

Keywords

Herniotomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  4 days postherniotoy

• Difference in Recovering Daily Activity

  4 days after surgical procedure

• Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications

  4 days postherniotomy

• Development of Persistent Postoperative Pain

  Up to 3 months

Study Arms (2)

ketorolac

OTHER

Patients will be given intraoperative analgesia with Ketorolac and tramadol before the the end of surgery, then Ketorolac postoperative 10mg 1cp x 3/die, from the day of surgery for 4 days after surgery.

Drug: Ketorolac postoperative; Drug: intraoperative analgesia

acetaminophene+tramadol

OTHER

Patients will be given intraoperative analgesia with Ketorolac and tramadol before the the end of surgery, then postoperative Patrol (acetaminophene 325mg+tramadol 37,5mg) 1cp x 3/die for 4 days after surgery.

Drug: postoperative Patrol; Drug: intraoperative analgesia

Interventions

Ketorolac postoperative DRUG

Ketorolac 10mg 1cp x 3/die

Also known as: Toradol

ketorolac

postoperative Patrol DRUG

acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die

Also known as: Patrol

acetaminophene+tramadol

intraoperative analgesia DRUG

ketorolac 30 mg iv

Also known as: Ketorolac

acetaminophene+tramadol; ketorolac

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• University of Pavia: collaborator

Study Sites (2)

IRCCS Policlinico San Matteo

Pavia, Lomabardy, 27100, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, Lombardy, 21100, Italy

Location

Related Publications (1)

• Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30.

  PMID: 26329661 DERIVED

MeSH Terms

Conditions

Hernia

Interventions

Ketorolac Tromethamine; Ketorolac; Tramadol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Results Point of Contact

• Title: Dr Massimo Allegri
• Organization: IRCCS Policlinico S Matteo

massimo.allegri@unipv.it

00390382502627

Study Officials

• Fabrizio Cavalloro, MD

  IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 29, 2011
• Study Start: March 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

IT (2)