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Total Hip Arthroplasty: Multiple Blocks by UltraSound (THAMBUS)

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Ropivacaine
Ultrasound
Peripheral nerve blockade
Saline
Total hip arthroplasty
Bupivacaine
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Hip arthroplasty, Peripheral nervous blockade, Postoperative, Pain, Ropivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Minimum 18 years of age
  • Patients scheduled for primary, unilateral hip arthroplasty with spinal anaesthesia
  • Patients who have given their written and informed consent to participation after having understood the content and limitations of the protocol fully
  • ASA 1-3

Exclusion Criteria:

  • Patients who are not able to co-operate
  • Patients who do not speak or understand Danish
  • Daily use of opioids corresponding to 40 mg of morphine daily
  • Allergy towards the drugs used in the study
  • Drug abuse (investigators judgement)
  • Alcohol consumption larger than advised by the Danish National Board of Health
  • Spinal anaesthesia is contraindicated or the patient wants a general anaesthesia
  • Patients in whom the blockade procedure or the spinal anaesthesia procedure cannot be completed because of technical difficulties

Sites / Locations

  • Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

B3: Blockade of three nerves

B2: Blockade of 2 nerves

K: Control group

Arm Description

Peripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.

Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine. Sham blockade of the femoral nerve with saline.

Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.

Outcomes

Primary Outcome Measures

Pain
Verbal Rating Scale score (0-10) at rest.

Secondary Outcome Measures

Pain
Assessed by: Verbal Rating Scale score (0-10) with passive flexion of the hip. Verbal Rating Scale score (0-10) with active flexion of the hip.
Opioid consumption
Bowel movement
Assessed by: Time for first stool Number of stools at intervals during the first 48 hours after surgery
Sedation
Assessed by the Pasero Opioid-induced Sedation Scale (POSS).
Nausea
Assesed by a verbal scale (none, light, moderate, marked) the consumption of antiemetics
Vomiting
Number of vomitings, estimated to have exceeded a volume of 10 ml.
Mental and physical condition
Assessed by: Big Five Inventory, subscales extrovert and neuroticism Modified Barthel Index/100 SF-8 index
Mobilization
The time at which the patient walks for the first time after surgery.
Length of stay
The time from end of surgery to discharge from the postoperative care unit The time from end of surgery to discharge from the hospital

Full Information

First Posted
January 13, 2011
Last Updated
October 21, 2015
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01276925
Brief Title
Total Hip Arthroplasty: Multiple Blocks by UltraSound
Acronym
THAMBUS
Official Title
The Effect of Ultrasound Guided Blockade of the Femoral Nerve, the Anterior Division of the Obturator Nerve, and the Lateral Femoral Cutaneous Nerve on Postoperative Pain, Morphine Consumption, and Mobilization After Total Hip Arthroplasty.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients undergoing total hip arthroplasty may experience severe postoperative pain. This is normally treated with opioids, which can cause side effects such as nausea, vomiting, obstipation and sedation. The hypothesis is that patients receiving peripheral nerve blockade of three nerves leading pain stimuli from the hip will experience less pain, will consume less opioid and therefore have less side effects, and will be mobilized more quickly than patients not receiving the peripheral nerve blockade.
Detailed Description
Total hip arthroplasty (THA) may cause significant postoperative pain. The patients are often elderly, and frequently have other diseases or ailments. Postoperative pain treatment must focus on effective pain relief, keeping adverse effects to a minimum, enhancing physical rehabilitation and reducing postoperative morbidity. Postoperative pain after hip surgery can be treated in different ways; i.e. paracetamol, NSAIDs, opioids, peripheral nerve blocks and epidural catheter. The choice seems to be influenced by local experience, education and personal preferences. Frequently, a multimodal approach is used with a combination of weak analgetics, opioids and maybe regional anaesthetic techniques. The sensory innervation of the hip is through branches from the lumbar and sacral plexuses. The femoral nerve (FN), the obturator nerve (anterior branch) (ONA) and the lateral femoral cutaneous nerve (LCFN) all stem from the lumbar plexus. The FN and ONA directly supply the hip joint. LCFN innervates the skin on the lateral part of the thigh, where the incision for THA is often made. The psoas compartment block provides good pain relief after THA, but the block can be associated with more frequent complications than other regional blockades for the lower extremity. Furthermore, the technique is difficult, and requires sub-specialized anaesthetists. In addition, it is often necessary to use electrical nerve stimulation together with ultrasound guidance to achieve a sufficient block. Blockade of the FN is standard for hip fractures in our hospital, but not standard for THA. Because of the analgetic effect in hip fractures, the PROSPECT group recommends blockade of FN for THA as well, though specific evidence is scarce on the subject. Blockade of the obturator nerve has been shown to provide pain relief for the hip joint, although the findings are not consistent, probably because of the varying innervation of the hip. The nerve is difficult to locate blindly, and location by nerve stimulator can be uncomfortable for the patient. Furthermore, the anatomic variations of the nerve and its branches is quite substantial. Previously, nerves were located by surface anatomic landmarks or by nerve stimulation. In the past 6-7 years, the use of ultrasound guidance has become an increasingly effective aid for applying peripheral nerve blockades with continuingly improving technology. Ultrasound-guided blockade of the three nerves (FN, ONA and LFCN) for postoperative pain treatment for THA is to our knowledge not previously described in the literature. From our knowledge of the anatomic course of the nerves, the investigators assume that the blockades can provide effective pain relief in this clinical context. Our aim in this trial is to study the effect of ultrasound-guided periferal nerve blockade of the femoral nerve, the obturator nerve (anterior branch), and the lateral femoral cutaneous nerve on postoperative pain, opioid consumption and mobilization after THA. The investigators want to describe the effect of blockade of the three nerves on pain, compared to placebo (injections with a well-known local analgesic drug compared to injections with isotonic saline). Because it is desirable to have the patient mobilized as quickly as possible after operation, it seems optimal to cause as little motor blockade as possible. The investigators therefore also want to investigate whether pain relief with blockade of ONA and LCFN without blockade of FN is better than or equal to placebo. The investigators want to study the possible differences in adverse effects, including motor blockade, between the groups with active nerve blockades, with and without blockade of FN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Hip arthroplasty, Peripheral nervous blockade, Postoperative, Pain, Ropivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B3: Blockade of three nerves
Arm Type
Active Comparator
Arm Description
Peripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.
Arm Title
B2: Blockade of 2 nerves
Arm Type
Active Comparator
Arm Description
Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine. Sham blockade of the femoral nerve with saline.
Arm Title
K: Control group
Arm Type
Sham Comparator
Arm Description
Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
7,5 mg/ml. 10 ml for the femoral nerve, 10 ml for the anterior division of the obturator nerve, 5 ml for the lateral femoral cutaneous nerve.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
7,5 mg/ml. 10 ml for the anterior division of the obturator nerve, 5 ml for the lateral femoral cutaneous nerve.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
All nerve blockades will be performed with ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Peripheral nerve blockade
Intervention Description
All patients will receive injections around the three nerves before surgery.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Isotonic. 10 ml for the femoral nerve.
Intervention Type
Procedure
Intervention Name(s)
Total hip arthroplasty
Intervention Description
All patients undergoes total hip arthroplasty.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcain spinal
Intervention Description
5 mg/ml. 3 ml for spinal anaesthesia.
Primary Outcome Measure Information:
Title
Pain
Description
Verbal Rating Scale score (0-10) at rest.
Time Frame
At intervals during the first 48 hours after surgery
Secondary Outcome Measure Information:
Title
Pain
Description
Assessed by: Verbal Rating Scale score (0-10) with passive flexion of the hip. Verbal Rating Scale score (0-10) with active flexion of the hip.
Time Frame
At intervals during the first 48 hours after surgery
Title
Opioid consumption
Time Frame
In intervals during the first 48 hours after surgery
Title
Bowel movement
Description
Assessed by: Time for first stool Number of stools at intervals during the first 48 hours after surgery
Time Frame
Within the first 48 hours after surgery
Title
Sedation
Description
Assessed by the Pasero Opioid-induced Sedation Scale (POSS).
Time Frame
At intervals during the first 48 hours after surgery
Title
Nausea
Description
Assesed by a verbal scale (none, light, moderate, marked) the consumption of antiemetics
Time Frame
At intervals during the first 48 hours after surgery
Title
Vomiting
Description
Number of vomitings, estimated to have exceeded a volume of 10 ml.
Time Frame
In intervals during the first 48 hours after surgery
Title
Mental and physical condition
Description
Assessed by: Big Five Inventory, subscales extrovert and neuroticism Modified Barthel Index/100 SF-8 index
Time Frame
Before and at intervals during the first 48 hours after surgery
Title
Mobilization
Description
The time at which the patient walks for the first time after surgery.
Time Frame
The first 48 hours after surgery
Title
Length of stay
Description
The time from end of surgery to discharge from the postoperative care unit The time from end of surgery to discharge from the hospital
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum 18 years of age Patients scheduled for primary, unilateral hip arthroplasty with spinal anaesthesia Patients who have given their written and informed consent to participation after having understood the content and limitations of the protocol fully ASA 1-3 Exclusion Criteria: Patients who are not able to co-operate Patients who do not speak or understand Danish Daily use of opioids corresponding to 40 mg of morphine daily Allergy towards the drugs used in the study Drug abuse (investigators judgement) Alcohol consumption larger than advised by the Danish National Board of Health Spinal anaesthesia is contraindicated or the patient wants a general anaesthesia Patients in whom the blockade procedure or the spinal anaesthesia procedure cannot be completed because of technical difficulties
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgitte M Krogh, MD
Phone
+45 50507405
Email
sommanbehager@yahoo.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Jensen, MD
Phone
+45 40259668
Email
usg.pnb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte M Krogh, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD
Phone
+45 40259668
Email
usg.pnb@gmail.com
First Name & Middle Initial & Last Name & Degree
B
First Name & Middle Initial & Last Name & Degree
Kenneth Jensen, MD
First Name & Middle Initial & Last Name & Degree
Birgitte M Krogh, MD
First Name & Middle Initial & Last Name & Degree
Katja Lenz, MD
First Name & Middle Initial & Last Name & Degree
Jepser Hvolris, MD

12. IPD Sharing Statement

Learn more about this trial

Total Hip Arthroplasty: Multiple Blocks by UltraSound

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