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

NCT02161484 | Terminated Results

• 1 other identifier: PRO13030184
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Peripheral Nerve Block; Total Hip Replacement

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively

  48 hours after the start of the surgery

• Amount of Oxycodone for the First 48 h Post Operatively

  48 hours after the start of the surgery

• Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively

  48 hours after the start of the surgery

• Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively

  48 hours after the start of the surgery

• Total Amount of Local Anesthetic in 48 Hours Post Operatively

  48 hours after the start of the surgery

Other Outcomes (1)

• Incidence of Complications (e.g. Frequency of Foot-drop).

  48 hours after the start of the surgery

Study Arms (2)

Continuous Lumbar Plexus Block with Parasacral Nerve Block

EXPERIMENTAL

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

ACTIVE COMPARATOR

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%

Interventions

Continuous Lumbar Plexus Block PROCEDURE

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.

Continuous Lumbar Plexus Block with Parasacral Nerve Block; Lumbar Plexus Nerve Block

Parasacral Nerve Block PROCEDURE

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

Continuous Lumbar Plexus Block with Parasacral Nerve Block

Ropivacine 0.2% DRUG

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.

Continuous Lumbar Plexus Block with Parasacral Nerve Block; Lumbar Plexus Nerve Block

Bupivacaine 0.0625% DRUG

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.

Continuous Lumbar Plexus Block with Parasacral Nerve Block; Lumbar Plexus Nerve Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed and dated an Informed Consent Form.
• Subject is classified as a ASA (American Society of Anesthesiologists) status I-III
• Subject is age 18- 75 years old.
• Subject is having primary total hip arthroplasty
• No contraindication to peripheral nerve catheter ( local infection or hypocoagulable state)
• Patient willing to receive spinal anesthesia as operative anesthesia
• No known drug allergies to study medications
• Patients not expected to receive therapeutic anticoagulation in the postoperative period.

You may not qualify if:

• Subject inability to provide adequate informed consent.
• Age younger than 18 years or older than 75 years
• Any contraindication to the placement of lumbar plexus catheter, including local infection, hypocoagulable state.
• ASA (American Society of Anesthesiologists) physical status of IV or greater
• Any chronic painful conditions
• Preoperative opioid use
• Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively

Sponsors & Collaborators

• Rita Merman: lead

Study Sites (1)

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

Related 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.

  PMID: 19448235 BACKGROUND

• 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. doi: 10.1007/BF03016880.

  PMID: 12419722 BACKGROUND

• Morris GF, Lang SA, Dust WN, Van der Wal M. The parasacral sciatic nerve block. Reg Anesth. 1997 May-Jun;22(3):223-8. doi: 10.1016/s1098-7339(06)80005-2.

  PMID: 9168212 BACKGROUND

• 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. doi: 10.1213/01.ane.0000261260.69083.f3.

  PMID: 17513661 BACKGROUND

• 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.

  PMID: 21467563 BACKGROUND

• 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.

  PMID: 19122076 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Rita Merman, P.I.
• Organization: University of Pittsburgh

MermanRB@upmc.edu

41256322137

Study Officials

• Rita Merman, MD

  UPMC Presbyterian Shadyside

  PRINCIPAL INVESTIGATOR

• Jacques E. Chelly, MD, PhD, MBA

  UPMC Presbyterian Shadyside

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 11, 2014
• Study Start: January 1, 2014
• Primary Completion: June 17, 2014
• Study Completion: June 17, 2014
• Last Updated: March 29, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-03

Locations

US (1)