A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery

Postoperative Pain Clinical Trial

Official title:

A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01117610
• Other study ID #: ChungAngUH
• Status: Unknown status
• Phase: Phase 4
• First received: May 4, 2010
• Last updated: May 4, 2010
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2010
• Source: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.

Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.

Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.

Description:

Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• laminectomy

Exclusion Criteria:

• r/o infection

• reoperation

• mental change

• allergy to local anesthetics

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Placebo (one of medication)
patients in Group C will receive none of medication preoperatively and intraoperatively
• Ropivacaine (epidural injection)
patient in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.

Locations

Country	Name	City	State
Korea, Republic of	ChungAng University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale 4hour	Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.; To check the severity of pain VAS will be measured at post op 4hour.	post op 4hour
Secondary	visual analogue scale 24hour	Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.; To check the severity of pain VAS will be measured at post op 24hour.	Post Op 24 hour
Secondary	visual analogue scale 12 hour	Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.; To check the severity of pain VAS will be measured at post op 12 hour.	Post op 12 hour
Secondary	Visual analogue scale 48hour	Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.; To check the severity of pain VAS will be measured at post op 48 hour.	Post Op 48hour
Secondary	Opioid consumption 4hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 µg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured.	Post Op 4hour
Secondary	Opioid consumption 24hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 µg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from 12 hour to post op 24 hour will be measured.	Post op 24 hour
Secondary	Opioid consumption 12 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 µg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 4hour to post op 12 hour will be measured.	Post Op 12 hour
Secondary	Opioid consumption 48hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 µg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 24 hour to post op 48 hour will be measured	Post Op 48 hour
Secondary	FPB 4 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.	Post Op 4 hour
Secondary	FPB 12 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) from post op 4 hour to post op 12 hour will be measured.	post op 12 hour
Secondary	FPB 24 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 12 hour to post op 24 hour will be measured.	Post Op 24 hour
Secondary	FPB 48 hour	The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 24 hour to post op 48 hour will be measured.	Post Op 48 hour