Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade

Phase 4

Completed

• Conditions: Obturator Nerve Block; Total Hip Replacement
• Interventions: Drug: Bupivacaine-epinephrine; Procedure: Sham block; Procedure: Obturator nerve block; Drug: Sodium Chloride 9mg/mL

• Registration Number: NCT03064165
• Lead Sponsor: University of Aarhus

Brief Summary

The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Study Start: 2017-08-15
• Primary Completion: 2018-06-08
• Study Completion: 2018-06-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Patients for primary hip replacement in spinal anesthesia
• Age >= 18 years
• American Society of Anesthesiologists physical status classification score I-III
• Informed consent

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Exclusion Criteria

• Lacking the ability to corporate
• Lacking the ability to speak danish
• Planned discharge on the same day of surgery
• Neuropathy of the lower extremities
• Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
• Contraindications for dexamethasone
• Chronic opioid demanding pain
• Pregnancy
• Allergy towards one or both investigatory medicinal products
• Active treatment with amiodarone
• Active treatment with verapamil
• Active treatment with corticosteroids

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obturator nerve block	Bupivacaine-epinephrine	Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.
Obturator nerve block	Obturator nerve block	Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.
Sham block	Sham block	Postoperative sham-block with normal saline.
Sham block	Sodium Chloride 9mg/mL	Postoperative sham-block with normal saline.

Primary Outcome Measures

Name	Time	Method
Opioid dose 0-12 hour after total hip replacement	0-12 hour after completion of total hip replacement	Cumulated dose of opioid 0-12 hour after total hip replacement

Secondary Outcome Measures

Name	Time	Method
Incidences of emesis 0-18 hours after total hip replacement.	0-18 hours after completion of total hip replacement
Cumulated dose of ondansetron 0-18 hours after total hip replacement	0-18 hours after completion of total hip replacement
Cumulated dose of droperidol 0-18 hours after total hip replacement	0-18 hours after completion of total hip replacement
Length of stay on post anesthesia care unit after completion of total hip replacement	24 hours after completion of total hip replacement
Length of stay on hospital after completion of total hip replacement	Up to 2 days
Ability to ambulate 5 hours after surgery	5 hours after completion of total hip replacement	Ability to sit, stand, walk with tall rollator and walk with crutches
Motor control with operated leg	5 hours after completion of total hip replacement	Physiotherapist evaluating motor control with operated leg during ambulation.
Cumulated dose of opioid 12-18 hours after total hip replacement.	12-18 hours after completion of total hip replacement
Pain at rest at time of examination (numeric rating scale)	1, 2, 5, 7 and 24 hours after completion of total hip replacement
Pain at passive 90-degree hip flexion (numeric rating scale)	1, 2, 5, 7 and 24 hours after completion of total hip replacement
Worst pain during ambulation on the day of surgery	5 hours after completion of total hip replacement
Time from completion of surgery to first dose of opioid	24 hours after completion of total hip replacement
Intensity of nausea on time of examination (numeric rating scale)	1, 2, 5, 7 and 24 hours after completion of total hip replacement
Duration of spinal anesthesia	0-4 hours after completion of total hip replacement	Time from end of operation until regain of normal sensibility on anterior femur.
Self-reported sleep quality the first night after total hip replacement	24 hours after completion of total hip replacement	Self-reported sleep quality on a 3-point-scale: 2 = Undisturbed sleep; 1 = Sleep disturbed by other reasons than pain; 0 = Sleep disturbed by pain.

Trial Locations

Locations (1)

Elective Surgery Centre; 🇩🇰 Silkeborg, Denmark