Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion

Pain, Postoperative Clinical Trial

Official title:

Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03035656
• Other study ID #: 2016-2380
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2019
• Source: Horizon Health Network
• Contact: Erin E Bigney, BA MA
• Phone: 506 648 6028
• Email: cescresearch[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The following is a double blinded, randomized controlled clinical trial to test the hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single intra-operative epidural injection of Ropivaciane® will result in decreased postoperative pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2) Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if there are differences in pain management between MIS and open surgical procedures. The proposed study will add novel information to current knowledge by 1) exploring of the effects of intra-operative single epidural injection analgesic on patients receiving MIS compared to open surgery, and 2) investigate potential immediate and short-term functional improvements gained from intra-operative single injection of Ropivaciane®.

Description:

This double blinded, randomized clinical trial will test hypotheses by administering a single epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical activities and anesthesia will proceed as usual, with the addition of a single epidural injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective without transient weakness), 9 and the control group will receive 0.9% saline solution (10 ml). Accurate placement into the space will be verified by the injection of contrast medium (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior to surgery by pharmacy and coded; surgeons will administer according to the patient's code maintaining the double-blind procedure. It is important to note that treatment as usual differs between open and MIS cohorts. The question of interest is whether the addition of the epidural analgesic to current practices for each surgery type results in increased positive outcomes, whether this is due to synergistic effects or not. Following operative treatment, Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically indicated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 228
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada East Spine Centre

Exclusion Criteria:

• History of severe respiratory, renal or hepatic disease

• Previous spine surgery

• Known allergy to local anaesthesia

• Those who experience dural tear during operative procedure

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ropivacaine
Administration of Ropivaciane via epidural injection intra-operatively

Other:
• Saline
Administration of saline via epidural injection intra-operatively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Health Network

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Ambulation	The patient's ability to walk following surgery as measured using Ortho-Care Step Watch Activity Monitors (SAM) which will be attached to the patient's ankle during their stay in hospital.	Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.
Other	Adverse Events	Adverse Events (AEs) will be measured using the validated Spine Adverse	The total number of adverse events will be measured at the time of patient discharge, between 48 hours and 120 hours following surgical intervention
Primary	Change in Pain	Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain.	Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively
Secondary	Change in Disability	Measurement of disability attributed to "back problem" using the validated Oswestry Disability Index (ODI).	Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
Secondary	Change in General Health	Measurement of overall general health as measured by the validated Short Form General Health Survey (SF-12)	Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
Secondary	Change in Medication Use	Medication used to control pain post-operatively as given by a qualified health professional while the patient is in hospital.	Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.