Comparative study of Combination of dexmedetomidine with bupivacaine,lidobupivacaine and ropivacaine

Phase 4

Not yet recruiting

• Conditions: Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,

• Registration Number: CTRI/2020/12/030150
• Lead Sponsor: Dr Ramana Reddy MV

Brief Summary

INTRODUCTION

Inour institution, most of the surgeries on upper limb ( hand, fore-arm and elbow)are performed under brachial plexus blocks usually through supra-clavicularapproach using a mixture of 0.5% bupivacaine and 2 % lidocaine.Bupivacaine is  a racemic mixture of twostereoenantiomers dextrobupivacaine and levobupivacaine andprovides long duration of action but its maindisadvantageis because of its central nervous system  and cardiotoxic effects

In view of the above facts there isa trend to switch over to safer alternative anaesthetic agents likelevo-bupivacaine and ropivacaine.

Levobupivacaine, an S-enantiomer ofbupivacaine  has been reported to have alonger duration of analgesic effect compared with ropivacaine when used forspinal and epidural anesthesia]  and has favorable clinical profile and lessercardiotoxicity when compared with racemic bupivacaine

Severaladjuvants  such as dexmedetomidine (DMT),clonidine,fentanyl, etc are used in combination with local anaesthetic agents  to enhance their  blocking potential, thereby decreasing thetime of onset of the block and increasing the duration of the motor and sensory block. In this context, Alpha-2-adrenergic receptor (α2-AR) agonist, DMT isemerging as the most popular adjuvant.

DMT is being safelyused as an adjuvant for subarachnoid blocks in urological surgeries,orthopaedic procedures of lower limb and lower abdominal surgical procedures,[27]

 We hypothesized that addition of DMT asadjuvant to ropivacaine and levo-bupivacaine can enhance the block characteristics by extending the duration ofanalgesia into the post operative period. Accordingly we undertook the presentstudy to evaluate and compare the block characteristics of 0.5% bupivacaine,0.5% levo-bupivacaine, 0.75% ropivacaine with dexmedetomidine added as adjuvantversus  0.5% bupivacaine alone i.e.without DMT added an adjuvant. In our study we added DMT in a dose of  0.5 µg/kg body weight to the localanaesthetic agents used in the brachial plexus blocks performed throughsupraclavicular approach.

METHOD

Institutional Ethical Committee approval wasobtained vide RC. No:GVPIHCMT/IEC/20201208/02 dated 08-12-2020 of Dean,GVPIHCMT, Visakhapatnam Eighty adult patients of age  18 and 80 yrs of either sex with weightbetweeen 50 and 80kg and who  were ofAmerican Society of Anaesthesiologists (ASA) grade I and II, attending ourmedical college hospital for surgeries of upper limb were enrolled in thisstudy, to be undertaken between the period 01-1-2021 and 31-08-2021. WrittenInformed consent was obtained from all the participants after explaining indetail about the study protocol and all consequent risks and benefits in theirmother tongue in the presence of two witnesses. Exclusion criteria adapted forour study were patients with known allergy to study drugs, patient refusal oflocal anaesthetic block, patients suffering from neurological disorders,psychiatric disorders, mental retardation, uncontrolled hypertension anddiabetes mellitus, coagulation or bleeding abnormalities,pregnant women andlactating mothers, patients on adrenergic agonist/antagonist medications and infectionat the site of the block.

Patients  were randomly allocated to four groups of 20 each (n=20) by utilizingcomputer generated random grouping software: group B, group L, group R and groupC and  a sequentially numbered sealed opaque envelope method was  utilized for allocating the  individual patient to the respective studygroup. The anaesthetic drug mixture for the brachial plexus block was  prepared as per given schedule below by ananaesthesiologist who was further excluded from participating in patientassessment.

Patients ofgroup B (n=20) were given  30 ml of  0.5% bupivacaine  plus 0.5 µg/Kg body weight of DMT; Patients of group L(n=20) were given  30 ml of  0.5% levo-bupivacaine  plus 0.5 µg/Kg body weight of DMT; patients of group R(n=20)  were given 30 ml of  0.75% ropivacaine  plus 0.5 µg/Kg body weight of DMT and patients of  group C (n=20, )   weregiven 30 ml of  0.5% bupivacaine aloneand this group served as control arm for our study.

The primary outcome variablesstudied were the differences in the duration of the analgesia and the durationof motor and sensory  block.  The secondary outcome variables studied waswere the differences in the duration of onset of the motor and sensory  block, fluctuations  in haemodynamic variables like  heart rate (HR), mean arterial pressure(MAP),respiratory rate( RR) and arterial oxygen saturation (SaO2),  total dose of rescue analgesics administeredduring the 1st 24 hours of post operative period, Ramsay sedation score, surgeon assessment score and  patient satisfaction score and anyadverse events and drug-related side effects.

Brachial plexus block was  performed through  supraclavicular approach by an experienced anaesthesiologistdifferent from the one assessing the patient intra‑ and post‑operativelyand collecting the data for analysis.

Sensory and motor block blockade wasassessed every 2 min intervals for the initial 30 min. Sensory block was  tested by a pinprick sensation using a 23‑G needle inentire dermatomes innervated by median , radial , ulnar  and musculo cutaneous nerves. Onset of sensoryblock  was  considered when there was  a dull sensation to pin prick along thedistribution of any of these nerves. Complete sensory block was considered whenthere was a complete loss of sensation to pin prick. Degree of sensory block was graded as[29] Grade: 0 whensharp sensation of pin prick is  felt,Grade: 1, if analgesia and dull sensation is  felt and Grade: 2 when fully anaesthetised  and no sensation is  felt.

The duration of sensory block was  defined as the time interval between the onsetof sensory anaesthesia and the complete resolution of anaesthesia on allthe  nerve territories. The duration ofmotor block was defined as the time interval between the onset of motor blockand the recovery of complete motor function of the hand and forearm.

 Postoperatively,the patients were transferred to the recovery room for further monitoring. Painwas assessed by VNRS at every 30 min for 6 h, and then at every 1 hour tillthe patients complain of pain (VNRS  >3). Patients wereenquired regarding their satisfaction level about the anaesthetic experience ona 3 point patient assessment score.[32] (score 1= extremelydissatisfied -had severe pain and or other adverse events; score 2 = satisfied-had minimal pain only; score = 3 extremely satisfied, no pain or adverse eventsand comfortable during block and surgery).

Power analysis andsample size calculation  were based on apopulation standard deviation of one with respect to the duration of thesensory block  derived from  the results of previous studies. With 80% power and 5% alpha error to detecta difference in duration of the sensory block of one hour between groups, asample size of 15 patients per group was required. We included 20 patients ineach group for better validation of results and to compensate for any dropoutsin the middle of the study due to incomplete blocks. Atthe end of the study, all the data were compiled using Microsoft excelprogramme and the quantitative variables (parametric data)  were presented as mean ± SD and ordinal /nominal/categorical data (non parametric data) were presented as number andpercentage. Thedifferences between the groups  were  analysed using ANOVA, Variance ratiotest  and an appropriate  Post Hoc test for comparison between thegroups whenever required. Chi square test was  used for non parametric data. Statisticalanalysis was  carried out using MicrosoftWindows Excel 2007 and SPSS version 20.0 IBM and a P value of ≤ 0.05 was  considered as statistically significant.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-12-30
• Study Start: 2021-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Eighty adult patients of age 18 and 80 yrs of either sex with weight betweeen 50 and 80kg and who were of American Society of Anaesthesiologists (ASA) grade I and II, attending our medical college hospital for surgeries of upper limb between the period 01-1-2021 and 31-08-2021 to be enrolled in this study.

Exclusion Criteria

Exclusion criteria adapted for our study were patients with known allergy to study drugs, patient refusal of local anaesthetic block, patients suffering from neurological disorders, psychiatric disorders, mental retardation, uncontrolled hypertension and diabetes mellitus, coagulation or bleeding abnormalities,pregnant women and lactating mothers, patients on adrenergic agonist/antagonist medications and infection at the site of the block.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome variables studied were the differences in the duration of the analgesia and the duration of motor and sensory block	Sensory and motor block blockade was assessed every 2 min intervals for the initial 30 min and at 15 minute intervals till completion of surgery and in the first 24 hours of postoperative period

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be the differences in the duration of onset of the motor and sensory block, fluctuations in haemodynamic variables like heart rate (HR), mean arterial pressure (MAP),respiratory rate( RR) and arterial oxygen saturation (SaO2), total dose of rescue analgesics administered during the 1st 24 hours of post operative period, Ramsay sedation score, surgeon assessment score and patient satisfaction score and any adverse events and drug-related side effects.	At every 5 minute intervals after completion of the block till completion of the surgery and at 30 minute intervals thereafter till 1st 24 hours of post operative period

Trial Locations

Locations (1)

GVP Medical College; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

GVP Medical College

🇮🇳Visakhapatnam, ANDHRA PRADESH, India

Dr Ramana Reddy M V

Principal investigator

9908232415

drramanareddymoolagani@gmail.com