Anterior Cruciate Ligament (ACL) Tear
Conditions
Brief summary
The purpose of this research is to compare the effect of single-injection sciatic PNB to continuous sciatic PNB on 1) postoperative pain control as measured by self-reported pain scores, pain medication use, and unplanned hospital admission due to poor pain control, 2) active knee flexion, and 3) patient satisfaction with pain control following ACL reconstruction with a hamstring autograft. The results of this research have the potential to positively impact pain control for the adolescent population undergoing this surgical procedure and foster responsible utilization of limited resources.
Detailed description
SPECIFIC AIM 1. The first aim of the study is to explore the impact of sciatic PNB technique on hamstring donor site pain control postoperatively. H1.a. The extended duration of analgesia offered by continuous sciatic PNB decreases pain scores during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB. H1.b. The extended duration of analgesia offered by continuous sciatic PNB decreases oral pain medication use during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB. H1.c. The extended duration of analgesia offered by continuous sciatic PNB decreases the incidence of unplanned admission due to poor pain control during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB. SPECIFIC AIM 2. The second aim of the study is to explore the impact of sciatic PNB technique on active knee flexion postoperatively. H2. The extended duration of analgesia offered by continuous sciatic PNB does not delay active knee flexion during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB. SPECIFIC AIM 3. The third aim of the study is to explore the impact of sciatic PNB technique on patient satisfaction with postoperative pain control. H3.1. The extended duration of analgesia offered by continuous sciatic PNB improves patient satisfaction during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.
Interventions
DRUGSingle-injection sciatic PNB
Single-injection sciatic PNB is a regional anesthetic technique employed to anesthetize the sciatic nerve with a single dose of local anesthetic. This technique offers pain control for a limited amount of time based on the volume and concentration of local anesthetic used.
DRUGContinuous sciatic PNB
Continuous sciatic PNB entails placing a continuous perineural infusion (CPI) catheter so that local anesthetic may be released slowly but continuously adjacent to the sciatic nerve (perineural) for several days postoperatively. The continuous PNB has the ability to reliably provide analgesia on subsequent postoperative days. Participants my be randomized to receive an additional experimental continuous pain ball during surgery which can provide up to 48 hours of pain relief.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
A subject may be INCLUDED in this study if: 1. The subject is male or female; 2. The subject is of any racial or ethnic group; 3. The subject is age 10 years to 18 years (inclusive); 4. The subject is scheduled for the following: Unilateral ACL reconstruction with a hamstring autograft under general anesthesia on an outpatient basis, and not being performed in conjunction with any other surgical procedures; 5. The subject is American Society of Anesthesiologists (ASA) patient classification I-II; 6. The subject or legally authorized representative has consented to femoral and sciatic peripheral nerve blockade for the procedure and the consent for peripheral nerve blockade has been obtained by a clinician (MD, DO, CRNA or APN) authorized to obtain consent; 7. The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
Exclusion criteria
A subject will be EXCLUDED from this study if: 1. Additional surgical procedures are being performed concurrently; 2. The subject is ASA classification \> II; 3. The subject has pre-existing allergies to amide local anesthetics; 4. The subject receives sedation preoperatively; 5. The subject is schedule for overnight hospital admission; 6. The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study, including but not limited to coagulopathy, preexisting central or peripheral nervous systems disorders, and local infection or sores at the anticipated site of needle insertion; 7. Unsuccessful PNB or CPI catheter placement occurs during the study. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | 72 Hours | Guardian collects Numeric Rating Scale (NRS) pain score. The range is 0 - 10. 0 being no pain, 10 being the worst pain imaginable. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJamie Furstein, CRNA
AANA Foundation
Participant flow
Recruitment details
141 patients were enrolled in the study. Enrollment was to include 140 participants. I believe one patient was recruited accidentally. However, 123 patients completed the study, and 18 patients were withdrawn.
Pre-assignment details
Patients were assigned to one of two groups. They were either in the Experimental: Continuous Sciatic PNB, or the Active Comparator: Single-injection Sciatic PNB
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 9 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 57 |
| other Total, other adverse events | 0 / 63 | 0 / 57 |
| serious Total, serious adverse events | 0 / 63 | 0 / 57 |
Outcome results
None listed