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Assessment and Prevention of Acute Post-herniotomy Pain (PTSM04APHP)

Primary Purpose

Hernia

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ketorolac postoperative
postoperative Patrol
intraoperative analgesia
intraoperative analgesia
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring Herniotomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Policlinico San Matteo
  • Ospedale di Circolo e Fondazione Macchi

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ketorolac

acetaminophene+tramadol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Difference in Recovering Daily Activity
Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)
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.
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.

Full Information

First Posted
April 19, 2011
Last Updated
May 21, 2014
Sponsor
IRCCS Policlinico S. Matteo
Collaborators
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT01345162
Brief Title
Assessment and Prevention of Acute Post-herniotomy Pain
Acronym
PTSM04APHP
Official Title
Randomized, Prospective Study of the Assessment, Prevention and Management of Acute Post-herniotomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
Collaborators
University of Pavia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
Herniotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketorolac
Arm Type
Other
Arm Description
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.
Arm Title
acetaminophene+tramadol
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac postoperative
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac 10mg 1cp x 3/die
Intervention Type
Drug
Intervention Name(s)
postoperative Patrol
Other Intervention Name(s)
Patrol
Intervention Description
acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die
Intervention Type
Drug
Intervention Name(s)
intraoperative analgesia
Other Intervention Name(s)
Ketorolac
Intervention Description
ketorolac 30 mg iv
Intervention Type
Drug
Intervention Name(s)
intraoperative analgesia
Other Intervention Name(s)
Tramadol
Intervention Description
Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg
Primary Outcome Measure Information:
Title
Analgesic Efficacy
Description
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.
Time Frame
4 days postherniotomy
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded. Assessment of any difference between the two groups.
Time Frame
4 days postherniotoy
Title
Difference in Recovering Daily Activity
Description
Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)
Time Frame
4 days after surgical procedure
Title
Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications
Description
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.
Time Frame
4 days postherniotomy
Title
Development of Persistent Postoperative Pain
Description
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.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Cavalloro, MD
Organizational Affiliation
IRCCS Policlinico San Matteo
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
State/Province
Lomabardy
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
State/Province
Lombardy
ZIP/Postal Code
21100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26329661
Citation
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.
Results Reference
derived

Learn more about this trial

Assessment and Prevention of Acute Post-herniotomy Pain

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