Obturator Nerve Block in Total Hip Arthrosplasty

NCT04085640 | Completed

• 1 other identifier: NOCH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Interest of obturator nerve block for analgesia in total hip arthroplasty remains controversial. This regional anesthesia procedure could provide post-operative pain relief as obturator nerve is responsible for innervation of the internal part of the hip joint capsule. This randomized double-blind study aims to assess obturator nerve block for post-operative analgesia in total hip arthroplasty. Before the surgery, an ultrasound guided obturator nerve block will be performed with either 20cc of saline or ropivacaine 0.2% (a long-acting local anesthetics). After regional anesthesia, a general anesthesia will be performed for intraoperative period. This study aims to assess post-operative pain management during the first 24 hours. Ability to walk the day of the surgery will also be collected.

Conditions

Primary Total Hip Arthroplasty

Keywords

Hip Arthroplasty; regional anesthesia; obturator nerve block

Outcome Measures

Primary Outcomes (1)

• Oxycodone requirement in PACU

  In the PACU, patients will be assessed for pain using a verbal rating scale (VRS) (VRS, 0=no pain, 10=worst pain). Patients suffering from pain (VRS \> 4/10) will receive oxycodone 2 mg intravenous boluses / 3 minutes. Oxycodone requirement will be compared between interventional and control groups.

  Length of stay in PACU

Secondary Outcomes (4)

• Pain assessement

  Postoperative period : maximum 24 hours after surgery

• Postoperative Oxycodone consumption

  Postoperative period : maximum 24 hours after surgery

• Ability to walk

  Postoperative period : maximum 24 hours after surgery

• Side effects of opioids

  Postoperative period : maximum 24 hours after surgery

Study Arms (2)

Obturator nerve block with Ropivacaine

EXPERIMENTAL

Obturator nerve block will be performed before general anesthesia as descripted by Nielsen (RAPM, 2019). A linear transducer will be oriented in the transverse plane and placed in the inguinal crease. The tail of the transducer will be tilted distal in order to visualize the pectineus muscle (medial to the femoral vessels) at its insertion at the superior pubic ramus superficial to the external obturator muscle. An 80 mm nerve block needlewill be inserted in-plane from the lateral end of the transducer and advanced until the tip of the needle will be inside the interfascial plane between the pectineus and the obturator externus muscles. 20 milliliters of ropivacaine 2 mg/mL will be injected in the interfacial plane between the pectineus and external obturator muscles.

Other: Obturator nerve block with ropivacaine 0.2%.

Obturator nerve block with isotonic salin

SHAM COMPARATOR

The same procedure will be performed and 20 milliliters of isotonic saline will be injected in the interfacial plane between the pectineus and external obturator muscles

Other: Obturator nerve block with isotonic saline

Interventions

Obturator nerve block with ropivacaine 0.2%. OTHER

20 milliliters of ropivacaine 2 mg/mL will be injected in the interfacial plane between the pectineus and external obturator muscles.

Obturator nerve block with Ropivacaine

Obturator nerve block with isotonic saline OTHER

20 milliliters of isotonic saline will be injected in the interfacial plane between the pectineus and external obturator muscles.

Obturator nerve block with isotonic salin

Eligibility Criteria

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

You may qualify if:

• years and older
• Primary THA under general anesthesia
• Consent for participation
• Affiliation to the french social security system

You may not qualify if:

• Revision of hip arthroplasty
• Significant psychiatric disturbances
• Minor patient
• Pregnancy
• Breastfeeding
• Contraindication to any drug used in the protocol: acetaminophen, ketoprofen, nefopam, oxycodone, propofol, ketamine, Ropivacaine…
• Chronic pain
• Current use oral morphine or equivalents

Sponsors & Collaborators

• Clinique Medipole Garonne: lead

Study Sites (1)

Clinique Medipole Garonne

Toulouse, 31036, France

Location

Related Publications (1)

• Marty P, Chassery C, Rontes O, Vuillaume C, Basset B, Merouani M, Marquis C, Delussy A, Delbos MC, Ferre F, Bataille B, Joshi G, Delbos A. Obturator nerve block does not provide analgesic benefits in total hip arthroplasty under multimodal analgesic regimen: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):657-662. doi: 10.1136/rapm-2021-102531. Epub 2021 May 5.

  PMID: 33952684 DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 11, 2019
• Study Start: January 14, 2020
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)