Phase 3
N=425
Surgical Pain After Inguinal Hernia Repair (SPAIHR)
Pain, Postoperative · Hernia, Inguinal
Bottom Line
View on ClinicalTrials.gov: NCT00551135 ↗Enrolled (actual)
425
Serious AEs
1.7%
Results posted
Jul 2010
Primary outcome: Primary: Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery — 5.2; 5.4; 4.7; 5.4 scores on scale — p=0.0668
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (Drug); placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- Male
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery |
5.2; 5.4; 4.7; 5.4 | 0.0668 |
| SECONDARY Numeric Rating Scale (NRS): Current Pain With Movement - Sitting |
1.3; 1.2; 1.0; 1.1; 0.7; 0.6 | 0.4471 |
| SECONDARY Numeric Rating Scale (NRS): Current Pain With Movement - Walking |
1.9; 1.6; 1.9; 2.0; 1.2; 1.1 | 0.6896 |
| SECONDARY Numeric Rating Scale (NRS): Current Pain With Movement - Coughing |
2.4; 1.8; 2.2; 2.1; 1.4; 1.5 | 0.2912 |
| SECONDARY Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing |
146.22; 158.90; 148.25; 155.57; 143.82; 162.70 | 0.3970 |
| SECONDARY Numerical Rating Scale (NRS): Current Pain at Rest |
0.9; 0.7; 0.8; 0.7; 3.3; 3.7 | 0.2818 |
| SECONDARY Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC) |
133.8; 141.3; 132.3; 135.1 | 0.9025 |
| SECONDARY Numeric Rating Scale (NRS): Average Pain |
1.3; 1.3; 1.3; 1.4; 2.8; 3.0 | 0.6679 |
| SECONDARY Time From End of Surgery to First Rescue Medication |
— | — |
| SECONDARY Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS) |
— | — |
| SECONDARY Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU) |
— | — |
| SECONDARY Daily Sleep Interference Rating Scale (DSIRS) Score |
2.86; 2.61; 2.17; 3.18; 2.13; 2.01 | 0.3332 |
| SECONDARY Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery |
10.29; 9.44; 6.58; 16.03; 13.15; 14.10 | 0.0630 |
| SECONDARY Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study |
3938.81; 3930.57; 3892.96; 3770.07 | 0.4177 |
| SECONDARY Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS) |
0.2; 0.2; 0.1; 0.2; 0.2; 0.3 | 0.4273 |
| SECONDARY Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS) |
4; 2; 2; 2; 2; 3 | 0.4024 |
| SECONDARY Subject Global Evaluation of Study Medication (GESM) |
10; 8; 7; 15; 29; 28 | 0.1723 |
| SECONDARY Participants With Wound Healing Complications |
102; 102; 99; 101; 1; 0 | — |
| SECONDARY Participants With Physician Contacts Post-discharge |
0; 2; 1; 0; 1; 3 | 0.1927 |
| SECONDARY Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score |
20.2; 19.4; 18.4; 16.4; 0.2; 3.2 | 0.1682 |
| SECONDARY Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score |
0.66; 0.68; 0.65; 0.66; -0.01; -0.01 | 0.7936 |
| SECONDARY Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales |
-3.5; -2.8; -3.6; -1.5; -6.2; -5.8 | 0.0830 |
| SECONDARY Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy |
— | — |
| SECONDARY Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS) |
46.43; 48.14; 46.44; 44.89; -6.86; -7.06 | 0.2136 |
| SECONDARY Participants With Chronic Postoperative Pain |
20; 24; 19; 26; 3; 5 | 0.2371 |
| SECONDARY Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf) |
0.86; 0.81; 1.43; 0.76; 0.58; 0.75 | — |
| SECONDARY Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI) |
0.03; 0.03; 0.05; 0.04; 0.02; 0.02 | — |
Summary
The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.
Eligibility Criteria
Inclusion Criteria
- The subject will have elective ( the subject chooses, but does not have to undergo surgery for an emergency) open unilateral inguinal herniorraphy (hernia repair), using mesh Lichtenstein surgery procedure and under general anesthesia and fentanyl or sufentanil/propofol initiation and sevoflurane or isoflurane maintenance plus local anesthetic infiltration at the conclusion of surgery. Study surgery should be anticipated to be in the morning.
- Expected to be able to use and tolerate non-steroidal anti-inflammatory drugs (such as naproxen), tramadol, oxycodone, and acetaminophen/paracetamol for pain control after surgery.
- The subject will be available for a visit within 72 hours of the day of surgery if not admitted the night before for baseline assessments before taking any study medication, and then to receive study medication prior to the day before surgery.
- The subject is expected and agrees to remain at the hospital (or intermediate care facility) for a minimum of 3 hours following surgery.
Exclusion Criteria
- Subjects with non elective or emergency surgery (must have the surgery no matter what), or hernia with incarceration (the trapping of abdominal contents within the hernia itself).
- Subjects with hernia repair that is not a primary repair. The planned use of nerve block or spinal/epidural/paravertebral anesthesia or surgery is not planned with general anesthesia.
- Subjects that are not allowed to receive the anesthesia agents indicated per protocol and general anesthesia.
Data sourced from ClinicalTrials.gov (NCT00551135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.