An interventional study of Continuous Lumbar Plexus Block and Parasacral Nerve Block in Osteoarthritis of Hip, Regional Anesthesia and Other Acute Postoperative Pain, sponsored by Rita Merman. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Rita Merman · Not applicable, Interventional, and Treatment
The purpose of this research study is to evaluate the analgesic efficacy of adding a single shot parasacral (sciatic) nerve block to a continuous lumbar plexus block in patients undergoing total hip replacement.
This prospective study is intended to assess the efficacy of placing a parasacral (sciatic) nerve block in addition to a lumbar plexus block for postoperative analgesia following total hip arthroplasty. Although the placement of a lumbar plexus block alone has become accepted as the standard of care at UPMC for postoperative analgesia following total hip arthroplasty, the addition of a parasacral (sciatic) nerve block may provide the advantage of blocking the superior gluteal nerve and nerve to the quadratus femoris which both supply small articular sensory branches to the posterior hip capsule.
642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 458 interventional studies indexed under Osteoarthritis, Hip.
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Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn. A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.
Procedure: Continuous Lumbar Plexus Block · Procedure: Parasacral Nerve Block · Drug: Ropivacine 0.2% · Drug: Bupivacaine 0.0625%
Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn. No sham/placebo parasacral (sciatic) blocks will be performed in this group.
Procedure: Continuous Lumbar Plexus Block · Drug: Ropivacine 0.2% · Drug: Bupivacaine 0.0625%
Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.
Also known as: Sciatic Nerve Block
Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm.
In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
Numeric Rating Scale (NRS) Pain Assessment
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time frame: 6 hours after the start of surgery
Numeric Rating Scale (NRS) Pain Assessment
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time frame: 24 hours after the start of surgery
Numeric Rating Scale (NRS) Pain Assessment
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
Time frame: 48 hours after the start of surgery
Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively
Time frame: 48 hours after the start of the surgery
Amount of Oxycodone for the First 48 h Post Operatively
Including number of dose and mg).
Time frame: 48 hours after the start of the surgery
Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively
Time frame: 48 hours after the start of the surgery
Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively
Time frame: 48 hours after the start of the surgery
Total Amount of Local Anesthetic in 48 Hours Post Operatively
Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)
Time frame: 48 hours after the start of the surgery
Incidence of Complications (e.g. Frequency of Foot-drop).
Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, "Foot Drop", allergic reaction will be recorded
Time frame: 48 hours after the start of the surgery
| Milestone | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block |
|---|---|---|
| Started | 5 | 5 |
| Completed | 1 | 2 |
| Not completed | 4 | 3 |
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
| units on a scale | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block |
|---|---|---|
| Pain at Rest | 2.6 ± 2.19 | 3.6 ± 1.67 |
| Pain with Movement | 3.5 ± 1.67 | 5 ± 1.87 |
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
| units on a scale | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block |
|---|---|---|
| Pain at Rest | 4.25 ± 2.75 | 2.2 ± 1.92 |
| Pain with Movement | 7.25 ± 2.5 | 4.4 ± 0.89 |
Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.
| units on a scale | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block |
|---|---|---|
| Pain at Rest | 1 ± 0 | 2 ± 1.14 |
| Pain with Movement | 8 ± 0 | 5 ± 1.41 |
No measurements were reported for this outcome.
Including number of dose and mg).
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)
No measurements were reported for this outcome.
Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, "Foot Drop", allergic reaction will be recorded
| Number of complications | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block |
|---|---|---|
| Incidence of Complications (e.g. Frequency of Foot-drop). | 0 | 0 |
Collected over From enrollment until 48 hours post-operatively or discharge from the hospital, whichever occurs first. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous Lumbar Plexus Block With Parasacral Nerve Block | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Lumbar Plexus Nerve Block | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block | Total |
|---|---|---|---|
| Mean | 56.8 ± 2.86 | 58.6 ± 7.67 | 57.7 ± 5.54 |
| Sex: Female, Male(Participants) | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block | Total |
|---|---|---|---|
| Female | 2 | 4 | 6 |
| Male | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 5 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Continuous Lumbar Plexus Block With Parasacral Nerve Block | Lumbar Plexus Nerve Block | Total |
|---|---|---|---|
| United States | 5 | 5 | 10 |
The record gives a start of Jan 2014, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2018, 3 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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