AzTrials
AzTrials

Primary Total Hip ArthroplastyNOCHNCT04085640

Obturator Nerve Block in Total Hip Arthrosplasty

A study testing Obturator nerve block with ropivacaine 0.2%. and Obturator nerve block with isotonic saline in people with Primary Total Hip Arthroplasty, run by Clinique Medipole Garonne at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Total Hip Arthroplasty
What is being tested?
Obturator nerve block with ropivacaine 0.2%. and Obturator nerve block with isotonic saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteFrance
Study dates
14 Jan 2020to 22 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Revision of hip arthroplasty
  • Significant psychiatric disturbances
  • Minor patient
  • Pregnancy
  • Breastfeeding
  • Patient is in exclusion period as determined by previous study
Show all 9Show fewer
  • Contraindication to any drug used in the protocol: acetaminophen, ketoprofen, nefopam, oxycodone, propofol, ketamine, Ropivacaine…
  • Chronic pain
  • Current use oral morphine or equivalents

Trial locations and contacts

1 site in 1 country.

France1 site
  • Clinique Medipole Garonne

    Toulouse, 31036

Other trials in France

About this study

Official title: Obturator Nerve Block in Total Hip Arthrosplasty. a Randomized Controlled Double Blind Study

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.

Read more

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.

Read the detailed description

The best strategy to provide post-operative analgesia in total hip arthroplasty (THA) remains controversial. Many procedures have been descripted.

Recent anatomical studies have reported that obturator nerve provide innervation of the internal part of the hip joint capsule. Obturator nerve block could be of major interest as it might improve post-operative analgesia without providing motor block of the quadriceps muscle. This could be associated with an early ability to walk and enhanced recovery.

This randomized double-blind study aims to assess obturator nerve block after THA.

After information, written informed consent will be obtained from all subjects before inclusion. At patient arrival in the anesthetic room, the research assistant will check the patient's consent. Using a computer-generated random number table, patients will be randomized in two-treatment groups by resource not part of the study.

We have planned to include patients aged ≥18 years who were scheduled for primary THA under general anesthesia at the Elective Surgery Center, Clinique Medipole Garonne, Toulouse, France. The Elective Surgery Center annually performs approximately 1500 total hip arthroplasties.

Exclusion criteria are revision of hip arthroplasty, pregnancy, breast feeding, significant psychiatric disturbances, history of relevant drug allergy, chronic pain, current use oral morphine or equivalents.

Obturator nerve block will be performed before general anesthesia as descripted by Nielsen (RAPM, 2019). A linear transducer (X-Porte, Fujifilm SonoSite, Bothell, Washington, USA) 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 needle (SonoPlex, PAJUNK Medizintechnologie, Geisingen, Germany) will 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 either ropivacaine 2 mg/mL or isotonic saline-depending on random group allocation-will be injected in the interfacial plane between the pectineus and external obturator muscles. Medication will be prepared by a staff member who won't be involved in the study and delivered in unidentifiable syringes.

As is common in our practice for patients undergoing THA, a standardized general anesthetic technique will be used for all patients including pre-administration of dexmedetomidine (1µg/kg) over 30 minutes, induction with ketamine (0.5 mg/kg), propofol (~3 mg/kg), and dexamethasone (0.15 mg/kg) and maintenance with continuous propofol (~7 mg/kg).

All patients received a standardized intra-operative analgesic strategy including systemic acetaminophen 1000mg, ketoprofen 100mg and nefopam 20mg. A local infiltration of local anesthetics (ropivacaine 0.2%) will be performed by the surgeon as descripted by Kerr. The first injection will be performed into the tissues around the rim of the acetabulum, focusing on both the joint capsule if it remains, and around the exposed gluteal and adductor muscles. The second injection will be made into the external rotators, gluteus tendon, and iliotibial band. The third injection will be made into the subcutaneous tissues under the wound.

In the post-anesthesia care unit (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.

Postoperative analgesic regimen for the first 24 hours' period will include acetaminophen 1000 mg orally every 6 hours, ibuprofen 400 mg orally every 8 hours and oxycodone 10 mg orally every 6 hours in case of VRS > 4/10.

Pain and adverse effects will be assessed each 6 hours during the first 24 hours. The day of the surgery, the ability to ambulate will be assessed by physiotherapists using a 4 point scale (0: Unable to get up; 1: walk <10m; 2: walk between 10 - 50m; 3: walk > 50m).

Patient's follow up ends at either the 24th hour of hospitalization or at patient discharge in day case surgery.

Being tested
Obturator nerve block with ropivacaine 0.2%., Obturator nerve block with isotonic saline
Keywords
Hip Arthroplasty, regional anesthesia, obturator nerve block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 isotonic salineOther

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

Study groups in NCT04085640
Study groupRoleWhat they receive
Obturator nerve block with RopivacaineExperimentalObturator 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.
Receives: Other: Obturator nerve block with ropivacaine 0.2%.
Obturator nerve block with isotonic salinSham comparatorThe 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
Receives: Other: Obturator nerve block with isotonic saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Length of stay in PACU

Secondary outcomes (4)
  1. Pain assessement

    Pain will be assessed every 6 hours using a VRS verbal rating scale ranging from 0 to 10 (0=no pain, 10=worst possible pain)

    Measured: Postoperative period : maximum 24 hours after surgery

  2. Postoperative Oxycodone consumption

    Oxycodone requirement will be compared between interventional and control groups.

    Measured: Postoperative period : maximum 24 hours after surgery

  3. Ability to walk

    The day of the surgery, the ability to ambulate will be assessed by physiotherapists using a 4-point scale (0: Unable to get up; 1: walk <10m; 2: walk between 10 - 50m; 3: walk > 50m).

    Measured: Postoperative period : maximum 24 hours after surgery

  4. Side effects of opioids

    Collect side effects associated with Oxycodone: nausea/vomiting, dizziness, urinary retention

    Measured: Postoperative period : maximum 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2019
  2. Study start14 Jan 2020
  3. Primary completion22 Sep 2020
  4. Study completion22 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04085640
Sponsor's protocol ID
NOCH
Acronym
NOCH
Status last verified
Dec 2020
First submitted
3 Sep 2019
Last updated
14 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33952684

Questions about this trial

What is this clinical trial studying?

A study testing Obturator nerve block with ropivacaine 0.2%. and Obturator nerve block with isotonic saline in people with Primary Total Hip Arthroplasty, run by Clinique Medipole Garonne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxycodone requirement in PACU (time frame: Length of stay in PACU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04085640, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in