Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy

NCT00624910 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INN-CB-002
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after abdominal hysterectomy surgery.

Conditions

Postoperative Pain

Keywords

Post Operative Pain; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Total Use of Opioid Rescue Analgesia

  Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome

  0 to 24 hours postoperatively

Secondary Outcomes (7)

• Total Use of Opioid Rescue Analgesia

  0 to 48 hours postoperatively

• Total Use of Opioid Rescue Analgesia

  0 to 72 hours postoperatively

• Pain Intensity Rating on a Visual Analog Scale (at Rest)

  At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively

• Time to First Use of Opioid Rescue Analgesia

  Actual time assessed during post operative period

• Pain Intensity Rating on a Visual Analog Scale (After Cough)

  At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively

Study Arms (3)

1

EXPERIMENTAL

A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure

Drug: Bupivacaine Collagen Sponge (CollaRx®)

2

PLACEBO COMPARATOR

A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure

Drug: placebo

3

NO INTERVENTION

The patient will recieve the standard of care, but no implant during surgery

Interventions

Bupivacaine Collagen Sponge (CollaRx®) DRUG

The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.

Also known as: CollRx Bupivacaine Implant

1

placebo DRUG

The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a body mass index (BMI) \> 19 and \< 40 kg/m2
• Had planned an elective total abdominal hysterectomy for reasons other than malignancies to be performed according to standard surgical technique using a standard incision and under general anesthesia with the following caveats:
• Laparoscopic procedures or supraumbilical or Maylard incisions will not be allowed
• A nonlaparoscopic incision for benign non-hysterectomy gynecological procedures (such as myomectomy or adnexal surgery) is acceptable if the surgical indication is not to treat pelvic pain
• No concomitant vaginal procedures are allowed. An abdominal urethropexy and an incidental appendectomy will be allowed
• Have a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA)
• Have a negative pregnancy test
• Be free of other physical or mental conditions which may confound assessment of postoperative pain
• Have the ability to read, understand and comply with the study procedures and the use of the pain scales; is capable of operating a patient-controlled analgesia (PCA) device; and is able to communicate meaningfully with the study staff
• Voluntarily sign and date an informed consent form (ICF), prior to the conduct of any study-specific procedures
• Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study

You may not qualify if:

• Known hypersensitivity to any active or inactive ingredient of the test articles
• Presence of clinically significant cardiac arrhythmias or atrioventricular (AV) conduction disorders
• Concomitant use of other amide local anesthetics
• Concomitant use of antiarrhythmics
• Concomitant use of propanolol
• Concomitant use of strong/moderate CYP3A4 inhibitors or inducers
• Has used aspirin or aspirin-containing products within 7 days of surgery.
• Previous major surgery in the last 3 months
• Requires any additional surgical procedures during the same hospitalization (except as noted)
• Received neuraxial (spinal or epidural) opioid analgesics either prior to or during surgery
• Received local anesthetic infiltration of the surgical wound prior to, during or immediately after closure
• Is scheduled to receive local anesthetics via an indwelling catheter after surgery
• Underwent additional procedures during surgery, which may increase the visceral pain
• Has known or suspected history of alcohol or drug abuse or misuse or evidence for tolerance or physical dependency on opioids analgesics or sedative-hypnotic medications
• Uses opioids or tramadol daily for \> 7 days prior to test article administration

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (1)

Forsyth Medical Centre - OB Anesthesia

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
• Organization: Innocoll

ctucker@innocoll.com

484-406-5211

Study Officials

• David Prior

  Innocoll

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: December 27, 2007
• Primary Completion: September 5, 2008
• Study Completion: September 5, 2008
• Last Updated: July 23, 2021
• Results First Posted: January 12, 2021

Record last verified: 2021-07

Locations

US (1)