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

Total Hip Replacement Clinical Trial

Official title:

Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064165
• Other study ID #: HIP/FUSION#2
• Status: Completed
• Phase: Phase 4
• Start date: August 15, 2017
• Est. completion date: June 8, 2018

Study information

• Verified date: September 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 8, 2018
• Est. primary completion date: June 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Obturator Nerve Block
• Total Hip Replacement

Intervention

Drug:
• Bupivacaine-epinephrine
Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.

Procedure:
• Sham block
Injection as for obturator nerve block, but with placebo
• Obturator nerve block
Postoperative obturator nerve block

Drug:
• Sodium Chloride 9mg/mL
Placebo

Locations

Country	Name	City	State
Denmark	Elective Surgery Centre	Silkeborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Elective Surgery Centre, Silkeborg Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid dose 0-12 hour after total hip replacement	Cumulated dose of opioid 0-12 hour after total hip replacement	0-12 hour after completion of total hip replacement
Secondary	Cumulated dose of opioid 12-18 hours after total hip replacement.		12-18 hours after completion of total hip replacement
Secondary	Pain at rest at time of examination (numeric rating scale)		1, 2, 5, 7 and 24 hours after completion of total hip replacement
Secondary	Pain at passive 90-degree hip flexion (numeric rating scale)		1, 2, 5, 7 and 24 hours after completion of total hip replacement
Secondary	Worst pain during ambulation on the day of surgery		5 hours after completion of total hip replacement
Secondary	Time from completion of surgery to first dose of opioid		24 hours after completion of total hip replacement
Secondary	Intensity of nausea on time of examination (numeric rating scale)		1, 2, 5, 7 and 24 hours after completion of total hip replacement
Secondary	Incidences of emesis 0-18 hours after total hip replacement.		0-18 hours after completion of total hip replacement
Secondary	Cumulated dose of ondansetron 0-18 hours after total hip replacement		0-18 hours after completion of total hip replacement
Secondary	Cumulated dose of droperidol 0-18 hours after total hip replacement		0-18 hours after completion of total hip replacement
Secondary	Length of stay on post anesthesia care unit after completion of total hip replacement		24 hours after completion of total hip replacement
Secondary	Length of stay on hospital after completion of total hip replacement		Up to 2 days
Secondary	Ability to ambulate 5 hours after surgery	Ability to sit, stand, walk with tall rollator and walk with crutches	5 hours after completion of total hip replacement
Secondary	Motor control with operated leg	Physiotherapist evaluating motor control with operated leg during ambulation.	5 hours after completion of total hip replacement
Secondary	Self-reported sleep quality the first night after 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.	24 hours after completion of total hip replacement
Secondary	Duration of spinal anesthesia	Time from end of operation until regain of normal sensibility on anterior femur.	0-4 hours after completion of total hip replacement