Phase 3 Completed N=501 Randomized Double-blind Treatment

Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

Pain, Postoperative

Source: ClinicalTrials.gov NCT00468845 ↗

Enrolled (actual)

501

Serious AEs

7.1%

Results posted

May 2011

Primary outcomePrimary: Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) — 7.1; 7.2; 7.4 Units on a scale — p=0.1378

Summary

To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.

Outcome Measures

Outcome	Result	p-value
PRIMARY Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)	7.1; 7.2; 7.4	0.1378
SECONDARY Current Pain - Pain With Movement Caused by Sitting	5.21; 5.53; 5.28; 3.57; 3.71; 3.67	0.7752
SECONDARY Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test	4.83; 4.92; 4.97; 3.22; 3.47; 3.46	0.5997
SECONDARY Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting	4.87; 5.01; 4.87	0.9676
SECONDARY Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test	4.45; 4.64; 4.61	0.4801
SECONDARY Current Pain at Rest	5.13; 5.39; 5.47; 4.06; 4.55; 4.30	0.2125
SECONDARY Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay	3.62; 3.58; 3.76	0.4388
SECONDARY Total Cumulative Dose of Opioids Following Surgery	113.38; 111.27; 124.44; 148.67; 144.95; 168.31	0.2409
SECONDARY Integrated Analgesic Score	-6.58; -11.66; 3.36; -5.51; -18.84; 5.48	0.2730
SECONDARY Non-opioid Rescue Medication - Paracetamol	1.16; 1.21; 1.22; 3.23; 3.20; 3.55	0.5995
SECONDARY Anxiety Before and After Surgery	31.9; 28.4; 33.3; 29.5; 29.7; 30.9	0.6613
SECONDARY Non-opioid Rescue Medication - Ibuprofen	0.01; 0.03; 0.01; 0.08; 0.15; 0.12	0.8940
SECONDARY Percent Change From Baseline in Peak Expiratory Flow	0; 0; 0; -39.25; -35.35; -41.29	0.5682
SECONDARY Timed Up-and-Go (TUG)	39.77; 42.79; 38.54; 31.82; 33.06; 29.25	0.6966
SECONDARY Average Daily Pain	3.9; 4.3; 3.1; 3.0; 3.2; 2.8	0.2201
SECONDARY Worst Daily Pain	4.3; 4.4; 4.2; 3.2; 3.4; 3.5	0.7511
SECONDARY Sleep Interference	2.4; 3.6; 3.2; 2.6; 2.3; 2.6	0.3323
SECONDARY Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores	0; 0; 0; 2.57; 2.62; 2.90	0.1975
SECONDARY Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores	0; 0; 0; 2.62; 2.60; 2.53	0.6295
SECONDARY Participant Satisfaction With Study Medication - Surgery Day	14.3; 3.1; 20.0; 42.9; 62.5; 35.0	0.6861
SECONDARY Participant Satisfaction With Study Medication - Day 1 PS	13.3; 17.6; 16.2; 56.0; 47.3; 45.5	0.4264
SECONDARY Participant Satisfaction With Study Medication - Day 2 PS	21.9; 17.6; 16.2; 49.1; 54.6; 47.0	0.0714
SECONDARY Participant Satisfaction With Study Medication - Day 3 PS	15.9; 17.5; 17.6; 52.3; 47.5; 50.0	0.7418
SECONDARY Participant Satisfaction With Study Medication - Day 4 PS	17.6; 5.3; 14.3; 52.9; 57.9; 42.9	0.6715
SECONDARY Participant Satisfaction With Study Medication - Day 5 PS	0; 7.7; 14.3; 71.4; 53.8; 42.9	0.9126
SECONDARY Participant Satisfaction With Study Medication - Discharge	29.6; 26.2; 26.4; 48.6; 51.0; 39.9	0.1233
SECONDARY Participant Satisfaction With Study Medication - Day 7 PS	36.6; 36.9; 25.2; 38.2; 37.7; 39.4	0.0361 sig
SECONDARY Participant Satisfaction With Study Medication - Day 14 PS	40.0; 42.9; 31.3; 42.3; 37.3; 33.6	0.0206 sig
SECONDARY Participant Satisfaction With Study Medication - Day 28 PS	42.4; 40.1; 34.3; 41.7; 34.5; 35.0	0.0287 sig
SECONDARY Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication	79.43; 78.45; 76.71; 82.52; 80.16; 78.26	0.1872
SECONDARY Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication	72.73; 66.28; 72.82; 76.41; 69.53; 69.05	0.9712
SECONDARY Quality of Life Using EuroQol (EQ-5D) Health State Profile	0.57; 0.61; 0.58; 0.81; 0.78; 0.78	0.8914
SECONDARY Time to Meet Hospital Discharge Criteria	57.670; 60.751; 58.745	0.7218
SECONDARY Time to Actual Discharge	79.339; 85.221; 78.740	0.7889
SECONDARY Incidence of Chronic Post-operative Pain	12.5; 17.3; 10.1; 6.5; 6.3; 4.3	0.9877
SECONDARY Total Clinically Meaningful Event (CME) Score	0.9; 0.8; 0.9; 1.1; 1.1; 1.2	0.9463

Eligibility Criteria

Inclusion Criteria

The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.
The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.
The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.

Exclusion Criteria

Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)
Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy
The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control
Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.
The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking <325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00468845). 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. Informational only — not medical advice.