The Co-administration of Dexamethasone or Adrenaline With Lignocaine 2% Prologues Duration in Inferior Alveolar Nerve Block- :A Comparative Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- onset time and duration of anaesthesia.
研究概览
简要总结
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.
详细描述
Background :
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 [Greene NM; 1971]. Currently, third molar surgery (TMS) has become the model most frequently used in acute pain trials because TMS is a 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. Halsted and Hall, 1884 reported the first successful nerve block ie inferior alveolar nerve block and went on to develop nerve and regional blocking techniques [Olch PD, William S; 1975]. These developments in the field of anaesthesia are possibly the most important advances for surgical specialities all over the world. Further, improvements in agents and techniques for local anaesthesia have occurred in the past 100 years. Today's variety of local anaesthetics agents are available can be administered with minimal irritation to tissue but inadequate analgesia, systemic toxicity and adverse local tissue are three principal challenge for clinicians. Local anaesthesia provides benefits of superior pain control, improved patient satisfaction, decreased stress response to surgery, achieve haemostasis, lesser complication with wide therapeutic margins (diminished postoperative nausea and vomiting), decreased logistic requirements, and decrease overall surgical cost. Moreover, clinicians often used local anaesthesia in an effort to improve perioperative analgesia and facilitate early mobilization either as an adjunct to general anaesthesia (GA) or as the primary anaesthetic. LA has become a useful therapeutic approach for managing perioperative pain, ensuring that patients are comfortable enough to be discharged home immediately after third molar surgery, (Robert DH, Sowray JH, 1979).
A broad cross-section of surgical patients consistently ranks postoperative pain as their highest concern highlighting the necessity for prolonged postoperative analgesia [Chew ST. et al, 1998, Razi S. et al 2008]. Usually, analgesia is short-lived, lasting less than 4 hours with all most all local anaesthetic agents. Additionally, the injection technique failure is another challenge to the clinician; past studies were reported the highest failure rate ( 10-39%) with an inferior alveolar nerve block (IANB) [Hung P et al, 2006; Boonsiriseth K et al, 2013]. The researchers have been trying mixing local anaesthetic with adjuvant drugs in an attempt to prolong analgesia from nerve blocks in brachial plexus, femoral, intercostal and interscalene nerve blocks. They found limited success with co-administration of adjuvants such as epinephrine, α2 agonist (i.e. clonidine and dexmedetomidine) opioids, ketamine, midazolam and hyaluronidase [Horliana et al, 2008]. However, co-administration of the dexamethasone was found to be effective for perioperative analgesia in an ample of TMS studies and other nerve blocks study both in the lab and clinical 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. Local anaesthetic agents that selectively inhibit pain pathways without interrupting transmission of other sensory pathways are not currently available. However, an accident finding of a previous study was impressive to increase the duration of analgesia with lignocaine 2% while the researcher tried to determine the effect of dexamethasone 8 mg on postoperative sequelae after TMS. Following after publication of the result, ample similar studies were conducted and found prolongation in the duration of IANB after injecting dexamethasone in pterygomandibular space. 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 null hypothesis for this study is "an addition of 2 ml dexamethasone (4mg/ml) or adrenaline ( 0.01mg/ml) to 2ml lignocaine (20 mg/ml) should have same effect of analgesia 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.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dexamethasone Group ( Group DXN)
Group DXN has received 4 ml Mixture B (2ml Lignocaine 2%+ 2ml dexamethasone 4mg/ml)
干预措施: inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml (Drug)
Adreanaline Group ( Group ADN)
Group ADN has received 4 ml Mixture A ( 2ml Lignocaine 2%+ 2ml freshly prepared solution of adrenaline 0.01mg/ml in normal saline)
干预措施: inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml (Drug)
结局指标
主要结局
onset time and duration of anaesthesia.
时间窗: one week post operative
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
次要结局
- trismus(one week post operative)
- post operative facial edema(one week post operative)
研究者
Dr Saroj Prasad Deo
Associate professor
Tribhuvan University, Nepal
