The Comparison of Postoperative Analgesia Between Adductor Canal Block and Femoral Nerve Block After Arthroscopic ACL Reconstruction With Hamstring Graft: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Thammasat University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Pain score (VAS) during activity
Study Overview
Brief Summary
The aim of this study is to compare the efficacy in pain relief within 24 hours between adductor canal block and femoral nerve block after anterior cruciate ligament reconstruction with hamstring graft.
Detailed Description
After approval from institutional ethic committees, Thammasat University Hospital, patients who meet the eligible criteria will be asked for informed consent. Randomization will be performed by computerization with varied block sizes (4 and 6), and the sequence of randomization will be concealed by sealed envelopes. Once given informed consent, the investigator opened the sealed envelope, which randomized the patient to the adductor canal block group (ACB), or the femoral nerve block group (FNB).
The day before surgery day, patients who meet the eligible criteria will ask for the informed consent from blinded research assistant. They will obtain patients' demographic data, preoperative pain scores, and quadriceps strength. They will be recommended how to evaluate pain score and use the patient-controlled analgesia.
In the block room, patients will be sedated with midazolam 2-3 mg intravenously. The nerve block will be performed before spinal anesthesia by unblinded anesthesiologists. During block, the patients will be blinded by sham block. In ACB group, patients will receive sham block of femoral nerve at inguinal area, and then ACB will be performed, while in FNB group, patients will receive FNB, and then sham block will be performed in the mid-femoral area.
After standard monitored, the saphenous nerve will be blocked in the ACB group under ultrasound guidance using linear probe (9 mHz, GE Healthcare®) with nerve stimulator (Payunk®) at midfemoral level. When the needle tip is positioned, the nerve stimulator is turned on and set to deliver a current of 0.5 mA at a frequency of 2 Hz and pulse duration of 0.1 ms. The presence of a quadriceps muscle twitch, if elicited, will be recorded, and the needle was re-positioned until the muscle twitch disappeared. Then, 0.5% levobupivacaine with adrenaline 5 µg/ml 15 ml will be injected.
The femoral nerve block is also performed in the FNB group under ultrasound guidance using linear probe (9 mHz, GE Healthcare®) and nerve stimulator (Payunk®). With ultrasound guidance, the femoral nerve is identified in femoral triangle near to femoral artery, and when the needle tip is in proper position in the ultrasound image, the nerve stimulator is used to confirm, the presence of quadriceps twitching at the current less than 0.5 mA, and the absence of quadriceps twitching at the current more than 0.2 mA. After that, 30 ml of 0.25% levobupivacaine with adrenaline 5 µg/ml is injected.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •arthroscopic anterior cruciate ligament reconstruction with hamstring graft at Thammasat University Hospital.
- •age 15-80 years
- •ASA class I-III
Exclusion Criteria
- •refuse to participate the study
- •morbid obesity (BMI ≥ 35 kg.m2)
- •allergic to any medication in the study
- •chronic opioid use or abuse
- •lower extremity neurological dysfunction
- •patients who cannot cooperate and assess pain score themselves.
Outcomes
Primary Outcomes
Pain score (VAS) during activity
Time Frame: 24 hours postoperative
Pain score during activity measured on Visual Analog Scale postoperative 24 hours. Adductor canal block VS Femoral nerve block
Secondary Outcomes
- Opioid consumption(0-24 hours postoperative)
- Pain score (VAS) at rest(4, 8, 12, 16, 20, 24 hours postoperative)
- Pain score (VAS) at activity(4, 8, 12, 16, 20 hours postoperative, and during quadriceps strength testing)
- duration (hours) after surgery-first time that patients pressing PCA(0-24 hours postoperative)
- Postoperative pruritus or rash(0-24 hours postoperative)
- The reduction of quadriceps strength from preoperative period both knees(8-12, 24 hours)
- Postoperative nausea and vomiting(0-24 hours postoperative)
- Postoperative urinary retention(0-24 hours postoperative)
- Postoperative respiratory depression(0-24 hours postoperative)
Investigators
Alisa Seangleulur
Department of Anesthesiology, Thammasat University
Thammasat University
