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

Primary Purpose

Pain

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Dexamethasone

Placebo

Morphine

Zofran

Paracetamol

Ibuprofen

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Analgesia, Postoperative, Dexamethasone, Spine surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Glostrup University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed Tablet Paracetamol 1 g orally and tablet Ibuprofen 400 mg orally. Both 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Morphine consumption

Total morphine consumption 0-24 hours after extubation time, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).

Painscore during rest and mobilization

Painscore during rest and during active mobilization (VAS scale) at time 48 hours after extubation time.

Degree of nausea

Degree of nausea 2, 4, 8, 12, 24 and 48 hours after extubation time

Incidence of vomiting

Total number of vomits 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.

Zofran consumption

Consumption of Zofran (milligram) 0-24 and 24-48 hours after extubation time.

Degree of sedation

Degree of sedation 2, 4, 8, 12, 24 and 48 hours after extubation time.

Quality of sleep

Quality of sleep 24 hours after extubation time.

Full Information

NCT ID

NCT01953978

First Posted

September 26, 2013

Last Updated

October 26, 2015

Sponsor

Rigshospitalet, Denmark

Collaborators

Glostrup University Hospital, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT01953978

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

Keywords

Pain, Analgesia, Postoperative, Dexamethasone, Spine surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Morphine

Intervention Description

Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.

Intervention Type

Drug

Intervention Name(s)

Zofran

Intervention Description

Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Intervention Description

Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

Primary Outcome Measure Information:

Title

Painscore during mobilization

Description

Time Frame

2-24 hours after extubation time.

Secondary Outcome Measure Information:

Title

Painscore during rest

Description

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.

Time Frame

2-24 hours after extubation time

Title

Morphine consumption

Description

Total morphine consumption 0-24 hours after extubation time, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).

Time Frame

0-24 hours after extubation time.

Title

Painscore during rest and mobilization

Description

Painscore during rest and during active mobilization (VAS scale) at time 48 hours after extubation time.

Time Frame

48 hours after extubation time

Title

Degree of nausea

Description

Degree of nausea 2, 4, 8, 12, 24 and 48 hours after extubation time

Time Frame

2, 4, 8, 12, 24 and 48 hours after extubation time

Title

Incidence of vomiting

Description

Total number of vomits 0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.

Time Frame

0-2, 2-4, 4-8, 8-12, 12-24 and 24-48 hours after extubation time.

Title

Zofran consumption

Description

Consumption of Zofran (milligram) 0-24 and 24-48 hours after extubation time.

Time Frame

0-24 and 24-48 hours after extubation time.

Title

Degree of sedation

Description

Degree of sedation 2, 4, 8, 12, 24 and 48 hours after extubation time.

Time Frame

2, 4, 8, 12, 24 and 48 hours after extubation time.

Title

Quality of sleep

Description

Quality of sleep 24 hours after extubation time.

Time Frame

24 hours after extubation time.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rikke Soennichsen, MD

Organizational Affiliation

Glostrup University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joergen B Dahl, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Glostrup University Hospital

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

27852230

Citation

Nielsen RV, Fomsgaard J, Mathiesen O, Dahl JB. The effect of preoperative dexamethasone on pain 1 year after lumbar disc surgery: a follow-up study. BMC Anesthesiol. 2016 Nov 16;16(1):112. doi: 10.1186/s12871-016-0277-z.

Results Reference

derived

PubMed Identifier

26270586

Citation

Nielsen RV, Siegel H, Fomsgaard JS, Andersen JDH, Martusevicius R, Mathiesen O, Dahl JB. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. Pain. 2015 Dec;156(12):2538-2544. doi: 10.1097/j.pain.0000000000000326.

Results Reference

derived

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

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