The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery

Pain Clinical Trial

Official title:

The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953978
• Other study ID #: SM-RS-2012
• Secondary ID: 2012-004181-18
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2013
• Last updated: October 26, 2015
• Start date: December 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.

Description:

The analgesic effect of dexamethasone is not well described, but studies have shown that an intermediate dosis of dexamethasone (0.11-0.2 mg/kg) can be a safe part of a multimodal analgesic strategy after surgery. Dexamethasone has an opioid-sparing effect and reduces pain during rest and mobilisation. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after herniated disk surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients undergoing lumbar disc surgery in general anaesthesia.

• Patients who have given their written consent to participate and understand the contents of the protocol.

• ASA 1-3.

• BMI > 18 og < 40.

• Fertile women need a negative HCG urine test.

Exclusion Criteria:

• Patients who cannot cooperate to the study.

• Patients who do not speak and/or understand Danish.

• Fertile women with a positive HCG urine test.

• Allergy to the drugs used in the trial.

• Alcohol or medicine abuse, assessed by investigator.

• Patients who have had spine surgery before.

• Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl)

• Daily oral steroid treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Dexamethasone
Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation

Other:
• Placebo
Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation

Drug:
• Morphine
Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
• Zofran
Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
• Paracetamol
Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
• Ibuprofen
Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

Locations

Country	Name	City	State
Denmark	Glostrup University Hospital	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Painscore during mobilization	Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time.	2-24 hours after extubation time.	No
Secondary	Painscore during rest	Painscore during rest (VAS scale) at time 2, 4, 8, 12 and 24 hours, calculated as area under curve (AUC) from 2-24 hours after extubation time.	2-24 hours after extubation time	No
Secondary	Morphine consumption	Total morphine consumption 0-24 hours after extubation time, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).	0-24 hours after extubation time.	No
Secondary	Painscore during rest and mobilization	Painscore during rest and during active mobilization (VAS scale) at time 48 hours after extubation time.	48 hours after extubation time	No
Secondary	Degree of nausea	Degree of nausea 2, 4, 8, 12, 24 and 48 hours after extubation time	2, 4, 8, 12, 24 and 48 hours after extubation time	No
Secondary	Incidence of vomiting	Total number of vomits 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.	0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.	No
Secondary	Zofran consumption	Consumption of Zofran (milligram) 0-24 and 24-48 hours after extubation time.	0-24 and 24-48 hours after extubation time.	No
Secondary	Degree of sedation	Degree of sedation 2, 4, 8, 12, 24 and 48 hours after extubation time.	2, 4, 8, 12, 24 and 48 hours after extubation time.	No
Secondary	Quality of sleep	Quality of sleep 24 hours after extubation time.	24 hours after extubation time.	No