NCT02866409

Brief Summary

This study has been designed to assess the efficacy of dexmedetomidine as an adjuvant to local anaesthetic agent bupivacaine in scalp nerve block and scalp infiltration to control post craniotomy pain.A third group where patients were administered bupivacaine only infiltration has also been created.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

August 3, 2016

Last Update Submit

August 10, 2016

Conditions

Headache

Keywords

dexmedetomidinenerve blockanesthesia infiltration

Outcome Measures

Primary Outcomes (13)

  • post craniotomy pain by Numerical rating scale (NRS)

    Numerical rating scale (NRS) is a scale from 0 to 10 where 0 shows 'no pain' and 10 shows 'worst imaginable excruciating pain

    Immediately after extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    30 minutes after extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    1 hour after extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    1.5 hours after extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    2 hours after extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    4 hours post extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    8 hours post extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    12 hours post extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    16 hours post extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    20 hours post extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    24 hours post extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    36 hours post extubation

  • post craniotomy pain by Numerical rating scale (NRS)

    48 hours post extubation

Secondary Outcomes (13)

  • chronic pain using Numerical rating scale (NRS)

    1 month

  • chronic pain using Numerical rating scale (NRS)

    3 months

  • post operative sedation using Modified Ramsay Sedation Scale

    15 minutes interval till 2hrs post extubation and then at 4, 8, 12, 16, 20, 24, 36 and 48 hours.

  • post operative sedation using Modified Ramsay Sedation Scale

    4 hours

  • post operative sedation using Modified Ramsay Sedation Scale

    8 hours.

  • +8 more secondary outcomes

Other Outcomes (56)

  • heart rate in beats per minute(bpm)

    15 minutes interval till 2hrs

  • heart rate in beats per minute(bpm)

    4 hours.

  • heart rate in beats per minute(bpm)

    8 hours.

  • +53 more other outcomes

Study Arms (3)

Bupivacaine,dexmedetomidine scalp block

EXPERIMENTAL

Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept \< 2 mg /kg for scalp block

Procedure: scalp blockDrug: DexmedetomidineDrug: Bupivacaine

bupivacaine dexmedetomidine infiltration

ACTIVE COMPARATOR

The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

Procedure: infiltrationDrug: DexmedetomidineDrug: Bupivacaine

bupivacaine infiltration

ACTIVE COMPARATOR

The incision site was infiltrated with 15-20 ml of bupivacaine (0.25%). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

Procedure: infiltrationDrug: Bupivacaine

Interventions

scalp blockPROCEDURE

In this group following nerves were blocked- 1. Supra-orbital nerve 2. Supra-trochlear nerve 3. Zygomatico-temporal nerve 4. Auriculo-temporal nerve 5. Posterior auricular branches of the greater auricular Nerve 6. The greater, lesser, and third occipital nerves

Bupivacaine,dexmedetomidine scalp block
infiltrationPROCEDURE

The incision site was infiltrated with drug. {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}.

bupivacaine dexmedetomidine infiltrationbupivacaine infiltration
DexmedetomidineDRUG

Dexmedetomidine was administered as a dose of 1 µg/kg in 20 ml 0.25% bupivacaine for scalp block or infiltration.

Also known as: Precedex, Dexdor
Bupivacaine,dexmedetomidine scalp blockbupivacaine dexmedetomidine infiltration
BupivacaineDRUG

20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration

Also known as: Marcaine, Sensorcaine, Marcain
Bupivacaine,dexmedetomidine scalp blockbupivacaine dexmedetomidine infiltrationbupivacaine infiltration

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neurosurgical patients
  • years of age
  • ASA class I and II
  • Patients undergoing elective craniotomy, who were conscious and oriented to time, person and place and able to understand and use Numerical Rating Scale (NRS)

You may not qualify if:

  • Patient dull and irritable
  • GCS \<15
  • Craniotomy incision extending beyond scalp (the field of the block) e.g. craniofacial surgery
  • Patients treated chronically with analgesics or narcotic medications
  • Allergy to local anaesthetics or dexmedetomedine
  • Patients planned for post-operative mechanical ventilation
  • Following patients were excluded from the study during collection of data in the postoperative period:-
  • Patients developing fever (≥39°C) in the postoperative period
  • Requiring postoperative ventilation (unplanned)
  • Having poor cognitive function at 1 hour postoperative period
  • GCS \<15 in post-operative period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Headache

Interventions

DexmedetomidineBupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior resident

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 15, 2016

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

August 15, 2016

Record last verified: 2016-08