Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement

Total Hip Arthroplasty Clinical Trial

Official title:

A Prospective, Randomized, Blinded, Controlled Study Evaluating the Efficacy of Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02161484
• Other study ID #: PRO13030184
• Status: Terminated
• Phase: N/A
• First received: June 2, 2014
• Last updated: March 2, 2018
• Start date: January 2014
• Est. completion date: June 17, 2014

Study information

• Verified date: March 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 17, 2014
• Est. primary completion date: June 17, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subject has signed and dated an Informed Consent Form.

2. Subject is classified as a ASA (American Society of Anesthesiologists) status I-III

3. Subject is age 18- 75 years old.

4. Subject is having primary total hip arthroplasty

5. No contraindication to peripheral nerve catheter ( local infection or hypocoagulable state)

6. Patient willing to receive spinal anesthesia as operative anesthesia

7. No known drug allergies to study medications

8. Patients not expected to receive therapeutic anticoagulation in the postoperative period.

Exclusion Criteria:

1. Subject inability to provide adequate informed consent.

2. Age younger than 18 years or older than 75 years

3. Any contraindication to the placement of lumbar plexus catheter, including local infection, hypocoagulable state.

4. ASA (American Society of Anesthesiologists) physical status of IV or greater

5. Any chronic painful conditions

6. Preoperative opioid use

7. Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively

Related Conditions & MeSH terms

• Lumbar Plexus Nerve Block
• Osteoarthritis
• Osteoarthritis of Hip
• Osteoarthritis, Hip
• Other Acute Postoperative Pain
• Pain, Postoperative
• Parasacaral (Sciatic) Nerve Block
• Peripheral Nerve Block
• Regional Anesthesia
• Total Hip Arthroplasty

Intervention

Procedure:
• Continuous Lumbar Plexus 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.
• Parasacral Nerve Block
A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.

Drug:
• Ropivacine 0.2%
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.
• Bupivacaine 0.0625%
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.

Locations

Country	Name	City	State
United States	UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rita Merman

Country where clinical trial is conducted

United States, 

References & Publications (6)

Ben-Ari AY, Joshi R, Uskova A, Chelly JE. Ultrasound localization of the sacral plexus using a parasacral approach. Anesth Analg. 2009 Jun;108(6):1977-80. doi: 10.1213/ane.0b013e3181a04d8e. — View Citation

Ho AM, Karmakar MK. Combined paravertebral lumbar plexus and parasacral sciatic nerve block for reduction of hip fracture in a patient with severe aortic stenosis. Can J Anaesth. 2002 Nov;49(9):946-50. — View Citation

Ilfeld BM, Mariano ER, Madison SJ, Loland VJ, Sandhu NS, Suresh PJ, Bishop ML, Kim TE, Donohue MC, Kulidjian AA, Ball ST. Continuous femoral versus posterior lumbar plexus nerve blocks for analgesia after hip arthroplasty: a randomized, controlled study. Anesth Analg. 2011 Oct;113(4):897-903. doi: 10.1213/ANE.0b013e318212495b. Epub 2011 Apr 5. — View Citation

Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079. — View Citation

Morris GF, Lang SA, Dust WN, Van der Wal M. The parasacral sciatic nerve block. Reg Anesth. 1997 May-Jun;22(3):223-8. — View Citation

Wiegel M, Gottschaldt U, Hennebach R, Hirschberg T, Reske A. Complications and adverse effects associated with continuous peripheral nerve blocks in orthopedic patients. Anesth Analg. 2007 Jun;104(6):1578-82, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Complications (e.g. Frequency of Foot-drop).	Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, "Foot Drop", allergic reaction will be recorded	48 hours after the start of the surgery
Primary	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.	6 hours after the start of surgery
Primary	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.	24 hours after the start of surgery
Primary	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.	48 hours after the start of surgery
Secondary	Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively		48 hours after the start of the surgery
Secondary	Amount of Oxycodone for the First 48 h Post Operatively	Including number of dose and mg).	48 hours after the start of the surgery
Secondary	Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively		48 hours after the start of the surgery
Secondary	Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively		48 hours after the start of the surgery
Secondary	Total Amount of Local Anesthetic in 48 Hours Post Operatively	Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)	48 hours after the start of the surgery