Does Addition of Longer-acting Local Anesthetic Improve the Post-operative Pain After Carpal Tunnel Release? A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Post-operative Analgesia Requirements
研究概览
简要总结
This study is being conducted to determine whether addition of a longer-acting local anesthetic to our current anesthetic protocol improves the post-operative pain after carpal tunnel release. Participants undergoing carpal tunnel release (CTR) will be randomly assigned to one of two groups: the standard anesthetic or the longer-acting anesthetic. Participants will not be aware of their assignment. Carpal tunnel release will be performed in the standard fashion at our hospital. Participants will record their post-operative pain on a visual scale at 2, 4, 6, 8, and 10 hours after surgery. They will also record the location of their post-operative numbness at the same time intervals. The day after surgery, a research nurse will call each participant to inquire about their post-operative pain scores and numbness. Participants will also be asked about their consumption of oral painkillers (e.g. Tylenol, ibuprofen) during the first 24 hours. Participants will be re-assessed 3 months after surgery to evaluate improvement in carpal tunnel symptoms.
Participants who wish to have carpal tunnel release on both wrists will be randomized to receive one type of anesthetic for the first side and will receive the other anesthetic for the second side. They will not be made aware of which medication is used for each side. This will allow us to directly compare the difference in pain experience between the two anesthetics.
We hypothesize that use of a longer-acting local anesthetic will lead to decreased post-operative pain, especially in the first 4-8 hours after surgery.
详细描述
A research nurse will meet with each patient presenting for outpatient CTR surgery at the Saskatoon City Hospital procedure room. He or she will obtain informed consent for interested participants. The patient will be assigned a subject number and be randomized to standard vs. bupivacaine treatment based on a computer algorithm. Participants will complete the Boston Carpal Tunnel Questionnaire as a baseline for comparison as well as a brief questionnaire on demographics. For those patients that are having both sides released during the study period, the first side will be randomized based on the study protocol and the second side will be anesthetized with the other treatment. They will be blinded to both procedures such that we can directly compare their operative experience.
The surgeon will draw up and mix the pre-determined local anesthetic (LA) for each patient based on the randomization protocol. The research nurse (who will be performing all assessments) and the patient will remain blinded to the type of anesthetic.
The two types of anesthetic will be:
- 10 mL 1% lidocaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate (standard treatment)
- 5 mL 1% lidocaine with 1:100,000 epinephrine + 5 mL 0.5% bupivacaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate (bupivacaine treatment)
The participants will be anesthetized in the standard fashion, with all 11 mL of LA infiltrated subcutaneously into the area of the incision. After a delay of 20-40 minutes, the CTR will be carried out using the standard mini-open approach. Patients will be provided with the standard post-operative instructions regarding activity and wound care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The surgeon administering the local anesthetic will not be blinded, however the participant and the research nurse (measuring outcomes) will be.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged >18 years undergoing carpal tunnel release
排除标准
- •Patients aged <18 years
- •Patients undergoing repeat carpal tunnel release
- •Patients undergoing simultaneous procedures for other hand/wrist pathology at the time of carpal tunnel release (i.e. trigger finger release, Dupuytren's, etc.)
- •Patients with a history of Rheumatoid Arthritis or a history or previous trauma or surgery to the local area (i.e. distal radius fracture)
- •Patients who lack the capacity to provide informed consent or understand the nature of the project
研究组 & 干预措施
Lidocaine
Administration of subcutaneous lidocaine as local anesthetic prior to carpal tunnel release (lidocaine intervention)
干预措施: Local Anesthetics Lidocaine (Drug)
Bupivacaine
Administration of subcutaneous bupivacaine + lidocaine as local anesthetic prior to carpal tunnel release (bupivacaine intervention)
干预措施: Local Anesthetics Bupivacaine (Drug)
结局指标
主要结局
Post-operative Analgesia Requirements
时间窗: 72 hours
Number of Tylenol and Ibuprofen tablets taken post-operatively within the first 24 hours. This was not measured on a scale. Patients were asked to count the total number of Tylenol (500mg) and Ibuprofen (200mg) tablets they consumed within the first 72 hours after surgery.
Post-operative Pain
时间窗: 24 hours post-op
Severity of pain as measured by the Visual Analogue Scale. This tool asks patients to rate their post-operative pain level from 0 to 10. 0 represents no pain, while 10 represents the worst possible pain.
次要结局
- Post-operative Numbness(72 hours post-op)
- Symptom Change at 3 Months(pre-operative/baseline (immediately before surgery), 3 months after surgery)
研究者
David Sauder
Principal Investigator, orthopedic surgeon
University of Saskatchewan