Clinical trial NCT00133133: Efficacy and Safety of ALGRX 4975 in the Treatment of Postoperative Pain After Gall Bladder Removal
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Open Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Postoperative pain
Open cholecystectomy
Capsaicin
Lead sponsor: AlgoRx Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain after gall bladder removal can be significant, mobility limiting and extend hospital stay. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. This study will determine whether ALGRX 4975 can provide pain relief following gall bladder removal.

Detailed description: Postoperative pain after open cholecystectomy can be significant and mobility limiting, causing increased risk of deep venous thrombosis, pulmonary complications, and extended hospital stay. With increasing emphasis on early postoperative mobilization, adequate postoperative pain control is essential. Acute postoperative pain is currently managed largely with opioids and co-administration of nonsteroidal anti-inflammatory drugs (NSAIDS). Opioids are highly effective in managing acute postoperative pain, however dosing is often limited by side effects such as respiratory depression, nausea and vomiting, and sedation. NSAIDS are administered to reduce opioid use, but may also have limiting side effects, such as gastrointestinal toxicity and platelet dysfunction. New strategies to manage acute postoperative pain would provide clinical benefit. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. This study will determine whether ALGRX 4975 can provide pain relief following open cholecystectomy.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing open cholecystectomy with the subcostal approach for cholelithiasis/cholecystitis
* American Society of Anesthesiologists (ASA) Class I or II

Exclusion Criteria:

* Active pancreatitis, any obstruction of the biliary tree, or hyperbilirubinemia (total bilirubin \> 2.5 mg/dL)
* Previous abdominal surgical procedure with the exception of inguinal hernia repair or appendectomy by the lateral approach or cesarean section or hysterectomy if the surgery was performed more than 1 year prior to study participation and the subject experienced no postoperative complications
* Diabetes mellitus with HbA1C \> 9.5 or a history of prolonged uncontrolled diabetes mellitus
* Systolic blood pressure greater than 150 mmHg or diastolic greater than 95 mmHg

Primary outcomes:
measure: Average numeric rating scale (NRS) scores for pain on ambulation assessed in the evening on the day of surgery and the first four postoperative days
Secondary outcomes:
measure: Time to first use and total supplemental pain medication use
measure: NRS scores for pain on the first 14 days postoperatively
measure: Spirometry on postoperative days 1 to 4
measure: Safety and tolerability
measure: Pharmacokinetics
Other outcomes:
Locations:
city: Belgrade
country: Former Serbia and Montenegro
facility: Emergency Center, Clinical Center of Serbia
Study officials:
affiliation: Emergency Center, Clinical Center of Serbia
name: Slobodan Krstic, MD
role: PRINCIPAL_INVESTIGATOR
References: