NCT02745288

Brief Summary

Mandibular resection which is an important component of maxillofacial cancer surgery is an extremely painful procedure associated with severe sympathetic response needing high doses of opioids. Inferior alveolar nerve block is a common nerve block used by dentists for mandibular dental extractions. The aim of this trial is to study the effect of this block for intraoperative analgesia in maxillofacial cancer surgeries requiring unilateral mandibular resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

April 15, 2016

Last Update Submit

November 20, 2016

Conditions

Mandibular Neoplasms

Outcome Measures

Primary Outcomes (1)

  • IV fentanyl requirement during primary tumour removal

    The total IV fentanyl dose required during primary tumour removal will be noted

    From start to finish ofprimary tumour removal procedure

Secondary Outcomes (4)

  • IV fentanyl requirement during neck dissection and primary tumour removal

    From start to finish of neck dissection and primary tumour removal

  • Maximum change in heart rate from baseline during primary tumour removal

    From start to finish of primary tumour removal procedure

  • Maximum change in blood pressure from baseline during primary tumour removal

    From start to finish of primary tumour removal procedure

  • Need for rescue analgesics or vasoactive agents during primary tumour removal

    From start to finish of primary tumour removal procedure

Study Arms (2)

Nerve block

EXPERIMENTAL

This arm will receive inferior alveolar nerve block

Procedure: inferior alveolar nerve block

control

NO INTERVENTION

Control arm will not receive inferior alveolar block

Interventions

inferior alveolar nerve blockPROCEDURE

A long acting local anaesthetic agent Inj Bupivacaine hydrochloride 0.5% (2 ml) will be given after induction by open mouth technique by landmark method. The mucobuccal fold will be palpated and traced till coronoid notch. The finger will be moved medially across the retromandibular trigone on internal oblique ridge. The 25G needle will be inserted till bone is felt. 2 ml of 0.5% bupivacaine will be injected slowly after withdrawing needle by 1mm and confirming negative aspiration of blood.

Nerve block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients between the age of 18 and 75 yrs classified as ASA I and II physical status requiring maxillofacial cancer surgery requiring unilateral mandibular resection and unilateral neck dissection

You may not qualify if:

  • \- surgery involving upper alveolar / maxillary resection
  • patients with BMI below 18kg/m2 and above 30kg/m2
  • allergy to local anaesthetic agent
  • Inability to give inferior alveolar nerve block due to any cause e.g. restricted mouth opening, obscured landmark or infection at site
  • pregnant women
  • patients unable to give valid consent e.g. patients with learning difficulties
  • patients on medications for hypertension
  • patients with preoperative pain requiring regular pain medications
  • uncontrolled haemodynamic status e.g. baseline arterial blood pressure above 160 /90 and baseline HR above 100 /min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, India, 400012, India

Location

MeSH Terms

Conditions

Mandibular Neoplasms

Condition Hierarchy (Ancestors)

Jaw NeoplasmsSkull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesJaw DiseasesMandibular DiseasesStomatognathic Diseases

Study Officials

  • Madhavi Shetmahajan, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, dept of anaethesia

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 20, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)