Effect of Supplementary Subperiosteal 0.75% Ropivacaine on Postoperative Outcomes After Mandibular Third Molar Extraction: a Randomized, Split-mouth Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity as Assessed by the Visual Analogue Scale (VAS) During the First 72 Hours After Surgery
研究概览
简要总结
This study examined whether an additional injection of the long-acting local anesthetic ropivacaine at the surgical site could reduce pain and improve recovery after removal of lower wisdom teeth. Adults aged 18 to 65 years who needed both lower wisdom teeth removed could take part. Each participant underwent two separate wisdom tooth removal procedures, approximately two weeks apart. After one procedure, ropivacaine was injected near the surgical area, while after the other procedure, a sterile saline solution was given in the same way for comparison. Neither the participant nor the surgeon knew which treatment was used at each procedure. Participants recorded their pain after surgery and their use of pain-relieving medication. Mouth opening and the effect of the procedure on daily life and oral health-related quality of life were also assessed. The purpose of the study was to determine whether adding ropivacaine at the surgical site could provide better pain relief and postoperative recovery than standard treatment alone.
详细描述
This was a single-center, randomized, double-blind, placebo-controlled, split-mouth clinical trial conducted in patients requiring surgical removal of both mandibular third molars.
Each participant underwent two separate surgical procedures two weeks apart. For each participant, one mandibular third molar surgical site was randomly assigned to receive supplementary 0.75% ropivacaine and the contralateral surgical site received 0.9% sterile saline as placebo. Treatment allocation to the right or left side was determined using a computer-generated randomization sequence. Sequentially numbered, sealed, opaque envelopes were used for allocation concealment. The study solutions were prepared in identical syringes. Both the participant and the surgeon were blinded to treatment allocation.
All surgical procedures were performed by the same oral surgery specialist using a standardized surgical technique. Standard local anesthesia consisted of an inferior alveolar nerve block and long buccal nerve block with articaine hydrochloride and adrenaline. Following extraction and suturing, 2 mL of either 0.75% ropivacaine or 0.9% sterile saline was administered subperiosteally at the buccal aspect of the surgical site, slightly apical to the extraction socket. At the second surgical appointment, the contralateral side received the alternate study treatment.
Postoperative management was standardized for both procedures. Participants received instructions regarding local cooling, oral hygiene, and use of chlorhexidine mouth rinse. Ibuprofen 400 mg was permitted as rescue analgesic medication when required.
Participants were followed for 7 days after each surgical procedure. The study was designed to assess whether supplementary subperiosteal ropivacaine administered after mandibular third molar surgery could improve postoperative recovery compared with placebo while allowing each participant to serve as their own control.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 支持治疗
- 盲法
- 三盲 (受试者、医护人员、研究者)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Age 18 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I.
- Presence of both mandibular third molars, with both teeth indicated for surgical extraction.
- Both mandibular third molars of the same Pell and Gregory classification.
- Satisfactory dental and oral health, without acute inflammatory processes at the surgical site or elsewhere in the oral cavity, including pericoronitis, pulpitis, or apical periodontitis.
- No use of analgesic medication within 24 hours before surgery.
- No use of antibiotics within 1 month before surgery.
- Ability and willingness to provide written informed consent.
- Willingness and ability to comply with study procedures and follow-up.
排除标准
- American Society of Anesthesiologists (ASA) physical status II, III, or IV.
- Pregnancy or breastfeeding.
- Known allergy to amide-type local anesthetics, vasoconstrictors, or related compounds.
- Use of dietary supplements that could affect local anesthesia.
- History of drug or analgesic abuse.
- Unsatisfactory dental or oral health, including untreated dental caries, periodontitis, or periapical lesions.
研究组 & 干预措施
Placebo-treated site
Following surgical extraction and suturing of the mandibular third molar, the assigned surgical site received a supplementary subperiosteal injection of 2 mL of 0.9% sterile saline at the buccal aspect of the extraction site.
干预措施: Saline (0.9% NaCl) (Other)
Ropivacaine-treated site
Following surgical extraction and suturing of the mandibular third molar, the assigned surgical site received a supplementary subperiosteal injection of 2 mL of 0.75% ropivacaine at the buccal aspect of the extraction site.
干预措施: Ropivacaine 0.75% (Drug)
结局指标
主要结局
Postoperative Pain Intensity as Assessed by the Visual Analogue Scale (VAS) During the First 72 Hours After Surgery
时间窗: 2, 4, 6, 12, 24, 48, and 72 hours after surgery
Participants recorded postoperative pain intensity using a Visual Analogue Scale (VAS) following each mandibular third molar extraction. Pain intensity was recorded separately after the ropivacaine-treated and placebo-treated procedures.
次要结局
- Postoperative Maximal Interincisal Opening as Assessed Using the TheraBite Range of Motion Scale(Postoperative days 1, 2, and 3)
- Time to First Postoperative Rescue Analgesic Intake(From completion of surgery until first rescue analgesic intake, assessed up to 72 hours after surgery.)
- Postoperative Rescue Analgesic Consumption(Day of surgery and postoperative days 1, 2, and 3)
- Oral Health-Related Quality of Life as Assessed by the Oral Health Impact Profile-14 (OHIP-14)(Postoperative day 7)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07844824
- 其他研究编号
- 05-PA-30-XXIX-9/2021
日期
- 首次提交
- (13天前)
- 首次发布
- (前天)
- 主要完成日期
- (2年前)
- 研究完成日期
- (2年前)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否