Trial Outcomes & Findings for Assessment and Prevention of Acute Post-herniotomy Pain (NCT NCT01345162)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

4 days postherniotomy

Results posted on

2014-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	100	100
Overall Study COMPLETED	98	96
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Protocol Violation	2	4

Baseline Characteristics

Assessment and Prevention of Acute Post-herniotomy Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=98 Participants 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	Acetaminophene + Tramadol n=96 Participants 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	Total n=194 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 14.6 • n=39 Participants	56.6 years STANDARD_DEVIATION 15 • n=41 Participants	56.6 years STANDARD_DEVIATION 14.8 • n=35 Participants
Sex: Female, Male Female	5 Participants n=39 Participants	9 Participants n=41 Participants	14 Participants n=35 Participants
Sex: Female, Male Male	93 Participants n=39 Participants	87 Participants n=41 Participants	180 Participants n=35 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ketorolac n=98 Participants 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	Acetaminophene + Tramadol n=96 Participants 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
Analgesic Efficacy	26.5 percentage of patients with NRS≥4	32.3 percentage of patients with NRS≥4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 days after surgical procedure

Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Acetaminophene + Tramadol

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketorolac n=98 participants at risk 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	Acetaminophene + Tramadol n=96 participants at risk 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
Gastrointestinal disorders stipsis	5.1% 5/98 • Number of events 5 • 3 months	9.4% 9/96 • Number of events 9 • 3 months
Blood and lymphatic system disorders bleeding	1.0% 1/98 • Number of events 1 • 3 months	0.00% 0/96 • 3 months
Nervous system disorders vertigo headache parestesia	2.0% 2/98 • Number of events 2 • 3 months	5.2% 5/96 • Number of events 5 • 3 months
Cardiac disorders hypotension	1.0% 1/98 • Number of events 1 • 3 months	0.00% 0/96 • 3 months
Renal and urinary disorders reactive hydrocele	1.0% 1/98 • Number of events 1 • 3 months	1.0% 1/96 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders dyspnea	1.0% 1/98 • Number of events 1 • 3 months	0.00% 0/96 • 3 months

Additional Information

Dr Massimo Allegri

IRCCS Policlinico S Matteo

Phone: 00390382502627

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place