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.
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.
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.
- Conditions
- Primary Total Hip Arthroplasty
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 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.
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)
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
Postoperative Oxycodone consumption
Oxycodone requirement will be compared between interventional and control groups.
Measured: Postoperative period : maximum 24 hours after surgery
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
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.
- First posted11 Sep 2019
- Study start14 Jan 2020
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Clinique Medipole Garonne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obturator Nerve Block in Total Hip Arthrosplasty. a Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT04085640
- Acronym / sponsor ID
- NOCH / NOCH
- Conditions
- Primary Total Hip Arthroplasty
- Keywords
- Hip Arthroplasty, regional anesthesia, obturator nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinique Medipole GaronneUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obturator nerve block with Ropivacaine | Experimental | Other: Obturator nerve block with ropivacaine 0.2%.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. |
| Obturator nerve block with isotonic salin | Sham comparator | Other: Obturator nerve block with isotonic salineThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Primary THA under general anesthesia
- Consent for participation
- Affiliation to the french social security system
Key exclusion criteria (9 listed)
- Revision of hip arthroplasty
- Significant psychiatric disturbances
- Minor patient
- Pregnancy
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obturator nerve block with ropivacaine 0.2%.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 |
| Obturator nerve block with isotonic saline20 milliliters of isotonic saline will be injected in the interfacial plane between the pectineus and external obturator muscles. | Other | Obturator nerve block with isotonic salin |
Primary outcome
Oxycodone requirement in PACU
Time frame: Length of stay 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.
4 secondary outcomes
Pain assessement
Time frame: Postoperative period : maximum 24 hours after surgery
Postoperative Oxycodone consumption
Time frame: Postoperative period : maximum 24 hours after surgery
Ability to walk
Time frame: Postoperative period : maximum 24 hours after surgery
Side effects of opioids
Time frame: Postoperative period : maximum 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 33952684Marty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.