Efficacy of Dexamethasone or Adrenaline in Inferior Alveolar Nerve Block

NCT04850885 | Completed Phase 3 DMC

• 1 other identifier: F-NMC/422/075/076
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Oral and dental professionals were responsible for the discovery of anaesthesia, given their close day-to-day contact with pain and, hence, their motivation to seek the means to alleviate it. Currently, third molar surgery (TMS) has become the model most frequently used in acute pain trials because third molar surgery (TMS) is simple and frequently used procedure with pain moderate or severe in intensity, as well as sufficient numbers of patients, are available for the required sample size for the studies. Effective local anaesthesia is arguably the single most important pillar upon which modern dentistry stands. Many agents are not available in the markets of Nepal that provide a rapid onset of surgical anaesthesia with adequate duration. The current study is designed to search for a better quality of perioperative analgesics with a single injection of dexamethasone and lignocaine in IANB preoperatively during TMS. The purpose of the current study is to evaluate the effectiveness and safety profiles of coadministration of dexamethasone (4mg/ml) or adrenaline ( 0.01mg/ml) with lignocaine 2% in IANB during TMS. Best of my knowledge this is a unique and novel clinical trial, probably the first trial which aim to overcome three principal challenges of local anaesthesia with a single injection during TMS.

Conditions

Oral Surgical Procedure

Keywords

Dexamethasone; Inferior alveolar nerve block

Outcome Measures

Primary Outcomes (1)

• onset time and duration of anaesthesia.

  Postoperative pain is rated on a 10 cm visual analogue scale (VAS) anchored by the verbal description "no pain" (0) and "very severe pain (9)" at every half an hourly up to 24 hours. When the patients began to experience moderate pain (VAS 4-5); it was considered that the anaesthetic effect of the test drugs was terminated. Then patient instructed to take analgesic only prescribed in the researcher. They were asked to record the time every time up to 7 days postoperatively. The nerve block was assessed objectively every two minute time interval (2, 4, 6, 8, 10 and 15 minute) with the application of cold sprit swabs/ice pack in the lower lip and by the response to atraumatic prick with the blunt instrument in a buccal and lingual mucoperiosteum in relation to 1st molar and canine teeth. The time of complete nerve block was achieved before starting the surgical procedure. T

  one week post operative

Secondary Outcomes (2)

• post operative facial edema

  one week post operative

• trismus

  one week post operative

Study Arms (2)

Dexamethasone Group ( Group DXN)

EXPERIMENTAL

Group DXN has received 4 ml Mixture B (2ml Lignocaine 2%+ 2ml dexamethasone 4mg/ml)

Drug: inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml

Adreanaline Group ( Group ADN)

ACTIVE COMPARATOR

Group ADN has received 4 ml Mixture A ( 2ml Lignocaine 2%+ 2ml freshly prepared solution of adrenaline 0.01mg/ml in normal saline)

Drug: inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml

Interventions

inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml DRUG

The modified technique of classical IANB was to be selected to avoid failure as described by Clark and Homes (1959). The patients were requested to keep their mouth wide open and an occlusal plane parallel to the floor. Palpation of anatomical landmarks was done properly and the guide finger was positioned at the retromolar fossa. A 5 ml syringe equipped with a 24 gauge needle length of 3.6 cm was used, it was been advanced from premolar on the opposite side into the tissue just above the fingernail until hitting the bone. The body of the syringe was redirected over the lower central incisors and kept parallel to the molars in a horizontal plane at the same time. The needle was inserted another 2 cm deep into the tissue and 3.5 ml of solution X was deposited 1 cm higher than the usual after multiple aspirations (90 degrees two planes). Further, 1 ml solution X was deposited after the withdrawn needle in pterygomandibular space.

Also known as: inj adreanaline 0.01mg/ml and inj lignocaine 20mg/ml

Adreanaline Group ( Group ADN); Dexamethasone Group ( Group DXN)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients above age 18 who need oral surgery under local anaesthesia and could understand and willing to take part in the study were selected.
• contraindications to Dexamethasone (i.e., peptic ulcer, renal insufficiency, pregnant women or lactating females ),
• allergy to NSAIDs ie piroxicam
• ASA physical status \> III
• any type of surgery other than a mention surgery performed under general anaesthesia
• patients with any condition precluding the limitation of intra-operative trial drugs ( lignocaine, adrenaline) administration (i.e., significant coronary artery disease, congestive heart failure)
• those receiving any premedications (including opioids, benzodiazepines, and clonidine )
• antibiotics or anti-inflammatory drugs within two weeks of the study entry. Also, radiograph showing high and bifid mandibular foramen were non included.

You may not qualify if:

• Subject who had to consume analgesic drugs other than the piroxicam 20 mg
• The subjects who did not respond on the VAS scale for 24 hourly and did not come for follow-up for 2nd and 7th postoperatively.

Sponsors & Collaborators

• Tribhuvan University, Nepal: lead
• National Medical College, Birgunj, Nepal: collaborator

Study Sites (1)

Saroj Prasad Deo

Birgunj, Two, 43000, Nepal

Location

Related Publications (3)

• Deo SP. Effect of submucosal injection of dexamethasone on post-operative sequelae of third molar surgery. JNMA J Nepal Med Assoc. 2011 Apr-Jun;51(182):72-8.

  PMID: 22916516 BACKGROUND

• Deo SP. Single-Dose of Submucosal Injection of Dexamethasone Affects the Post Operative Quality of Life After Third Molar Surgery. J Maxillofac Oral Surg. 2016 Sep;15(3):367-375. doi: 10.1007/s12663-015-0846-6. Epub 2015 Dec 7.

  PMID: 27752209 BACKGROUND

• Deo SP. Role of addition of dexamethasone to lignocaine 2% with adrenaline in dental nerve blocks for third molar surgery: A prospective randomized control trial. Ann Maxillofac Surg. 2016 Jul-Dec;6(2):260-266. doi: 10.4103/2231-0746.200341.

  PMID: 28299268 BACKGROUND

Study Officials

• Saroj P Deo, 10+2

  Tribhuvan University, Nepal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The blinding of this clinical study was done by confidential supporting staff. The supporting staff was hired for documentation and blinding. Details of role and responsibilities were described to him/her. The study materials ie 30 ml vial of lignocaine 2% (20 mg/ml Xylocaine, AstraZeneca, India); 2 ml in dexamethasone ( 4mg/ml Inj Dexona, Zydus Aliadac, India), in adrenaline 1mg/ml (Actiza, India), normal saline (NS) and identical 5ml syringe and file were given to supporting staff. On the day of surgery, he/she prepared drugs for IANB either the 4 ml Mixture B ( 2ml dexamethasone 4mg/ml + 2ml lignocaine 20mg/ml ) or 4ml Mixture A ( 2ml lignocaine 20mg/ml + 2ml adrenaline 0.01mg/ml, freshly prepared ) in 5 ml identical syringes as mentioned in block randomization chart. The patient name and age were documented the same in a file and a special code was generated and labelled on syringes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The non-probability convenience sampling method was used to select the subjects for this study based on availability and willingness to take part. Total 406 patients presented in department oral and maxillofacial surgery were examined and screened for the study. Detailed history, examination and radiograph ( orthopantomogram) were taken to evaluate disease and mandibular foramina. The sixty subjects were assigned randomly into two groups; DXN or ADN. Subjects were received either Mixture A and Mixture B for IANB on side of surgery. Group ADN has received 4 ml Mixture A ( 2ml Lignocaine 2%+ 2ml freshly prepared solution of adrenaline 0.01mg/ml in normal saline) whereas Group DXN was received 4 ml Mixture B (2ml Lignocaine 2%+ 2ml dexamethasone 4mg/ml).

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 20, 2021
• Study Start: August 1, 2020
• Primary Completion: February 2, 2021
• Study Completion: February 28, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-04

Locations

NE (1)