The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical Procedures
Participants are being asked to be a part of this study because they have been scheduled to receive a gum surgery to treat periodontal (gum) disease. After agreeing to participate a pain and medication log will be provided to participants and a 5 minute survey given.
Standard of care gum surgery will be done using local anesthesia with or without intravenous sedation according to the participant's preference. If the participant is sedated, they will be asked to have an escort to take them home after the surgery as is the standard of care.
At this visit, after the surgery is complete, the doctor will inject the area next to the area that surgery was done surgery with 4 ml (about a teaspoon) of one of two solutions decided by a random 1:1 draw. The participant will receive either liposomal bupivacaine (Exparel) which is a long-acting local anesthetic or 0.5% Bupivacaine HCl with a small amount of epinephrine, a medium-acting dental anesthetic.
After surgery, as standard of care, participants will be given instructions on taking over-the-counter medications as needed for pain.
Participants will be asked to fill out the pain survey and tablet log at specific times after leaving the clinic.
A standard of care follow-up visit with the doctor will be scheduled about 2 weeks after the surgery.
연구 개요
상세 설명
A randomized, double blinded clinical trial investigating the analgesic and anesthetic effect of liposomal bupivacaine when used after periodontal surgical procedures in addition to standard of care provided local anesthesia. These parameters will be compared to a control group that will receive 0.5% bupivacaine after completion of the procedure during which standard of care local anesthesia will be used.
Primary Objective:
Postoperative pain as measured with a Visual Acuity Scale (VAS) (NRS-21)
Secondary Objectives:
- Time (hours/minutes) for numbness due to local anesthetic to wear off
- Number of tablets of ibuprofen and acetaminophen consumed
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
-
-
Texas
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San Antonio, Texas, 미국, 78229
- University of Texas Health Science Center at San Antonio
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18 to 89 years old
- Require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures
- In either the maxillary or mandibular arch.
Exclusion Criteria:
- Pregnancy, or those planning to become pregnant
- Allergy or any medical issue using Bupivacaine
- Inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
- Non-English speaking
- Patients requiring narcotic medications for IV sedation
- Patients requiring either IV or oral steroids during the perioperative period
- Patients with liver disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Adjunctive long acting local anesthesia post surgery
The experimental group will receive a longer lasting formulation of bupivacaine (liposomal bupivacaine) as an adjunctive local infiltration
|
4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery
|
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활성 비교기: Adjunctive standard of care local anesthetic
The control group will receive a commonly used in dentistry local anesthetic (0.5% bupivacaine HCL) as an adjunctive analgesic after the end of the procedure.
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4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale
기간: 3 to 168 hours
|
Pain perceived at regular time intervals using a Visual Analogue Scale (NRS-21) rating their pain at specific time points on a scale from 0 to 10 with 0.5 points in between.
A higher score indicates more pain.
|
3 to 168 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time for numbness to wear off
기간: 3 to 168 hours
|
Amount of time in hours/minutes for numbness due to local anesthetic to wear off
|
3 to 168 hours
|
|
Number of of anti-inflammatory tablets taken
기간: Baseline to 7 days
|
Number of ibuprofen/Motrin tablets taken post surgery
|
Baseline to 7 days
|
|
Number of analgesic tablets taken
기간: Baseline to 7 days
|
Number of acetaminophen tablets taken post surgery
|
Baseline to 7 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- STUDY00000764
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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