Hernia
Conditions
Keywords
Herniotomy
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.
Interventions
DRUGpostoperative Patrol
acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die
ketorolac 30 mg iv
DRUGKetorolac postoperative
Ketorolac 10mg 1cp x 3/die
Sponsors
University of Pavia
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Efficacy | 4 days postherniotomy | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 4 days postherniotoy | 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 | 4 days after surgical procedure | 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 | 4 days postherniotomy | 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 | Up to 3 months | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Ketorolac 10mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die | 98 |
| Acetaminophene + Tramadol acetaminophene 325mg+tramadol 37,5mg
1cp x 3/die
postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die | 96 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 4 |
Baseline characteristics
| Characteristic | Ketorolac | Acetaminophene + Tramadol | Total |
|---|---|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 14.6 | 56.6 years STANDARD_DEVIATION 15 | 56.6 years STANDARD_DEVIATION 14.8 |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 93 Participants | 87 Participants | 180 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 98 | 12 / 96 |
| serious Total, serious adverse events | 0 / 98 | 0 / 96 |
Outcome results
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.
Time frame: 4 days postherniotomy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac | Analgesic Efficacy | 26.5 percentage of patients with NRS≥4 |
| Acetaminophene + Tramadol | Analgesic Efficacy | 32.3 percentage of patients with NRS≥4 |
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.
Time frame: 4 days postherniotomy
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.
Time frame: Up to 3 months
Secondary
Difference in Recovering Daily Activity
Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)
Time frame: 4 days after surgical procedure
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.
Time frame: 4 days postherniotoy