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

Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Silkeborg, Denmark, DK-8600
    • Elective Surgery Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obturator nerve block; Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.	Drug: Bupivacaine-epinephrine; Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.; Procedure: Obturator nerve block; Postoperative obturator nerve block
Placebo Comparator: Sham block; Postoperative sham-block with normal saline.	Procedure: Sham block; Injection as for obturator nerve block, but with placebo; Drug: Sodium Chloride 9mg/mL; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	Ability to sit, stand, walk with tall rollator and walk with crutches	5 hours after completion of total hip replacement
Motor control with operated leg	Physiotherapist evaluating motor control with operated leg during ambulation.	5 hours after completion of total hip replacement
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Elective Surgery Centre, Silkeborg Regional Hospital

Publications and helpful links

General Publications

• Nielsen ND, Runge C, Clemmesen L, Borglum J, Mikkelsen LR, Larsen JR, Nielsen TD, Soballe K, Bendtsen TF. An Obturator Nerve Block does not Alleviate Postoperative Pain after Total Hip Arthroplasty: a Randomized Clinical Trial. Reg Anesth Pain Med. 2019 Jan 23:rapm-2018-100104. doi: 10.1136/rapm-2018-100104. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): June 8, 2018
• Study Completion (Actual): June 8, 2018

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: HIP/FUSION#2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data will be shared through the Danish Data Archive.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No