scholarly journals Randomized clinical study comparing safety and efficacy of adjuvant intrathecal clonidine versus normal saline along with bupivacaine anaesthesia in lower limb surgery patients

Author(s):  
Brijesh Kumar ◽  
Kiran Shetty ◽  
Vijaya Kiran Shetty ◽  
Suresha K. R.

Background: Various adjuvants have been used in intrathecal anesthesia to avoid intraoperative visceral and somatic pain and prolong postoperative analgesia. Clonidine, partially selective α2-agonist, is being evaluated as a neuraxial adjuvant with intrathecal bupivacaine. The objective of the study was to evaluate and compare safety and efficacy of intrathecal clonidine as adjuvant to bupivacaine with control normal saline.Methods: American Society of Anesthesiologist grade 1 and 2 patients (60 patients) were randomly divided into two groups of 30 patients each for lower limb surgeries. Study group injected with intrathecal 3ml of 0.5% Bupivacaine heavy (15mg) + 1µg/kg of clonidine and control group injected with 3ml of 0.5% Bupivacaine heavy (15mg) + equivalent dose of normal saline. The onset and duration of sensory and motor block, duration of analgesia, and the incidence of side effects in both groups were observed and compared.Results: Time for 2 segment regressions in study group was 186.17±25.92 minutes compared to control was 103.20±19.15 minutes (p value<0.001). Total duration of analgesia in control was 226.50±35.69 minutes and in the study group was 465.67±100.37 minutes (p value<0.001). The average duration of motor block in control group was 181.17±26.12 minutes compared to study group was 217.80±41.51 minutes (p value<0.001). The small dose of intrathecal clonidine is not significantly associated with systemic side effects such as bradycardia and hypotension.Conclusions: Clonidine added to bupivacaine for intrathecal anesthesia effectively increases the duration of sensory block, duration of motor block and duration of analgesia and does not produce any significant hemodynamic changes. No significant side effects are associated with it.

2021 ◽  
pp. 55-58
Author(s):  
Rahul Wagh ◽  
Swapnil Sangale ◽  
Nagesh Jambure

Background: Various methods exist for treating post-operative pain which includes systemic narcotics, NSAIDS, patient-controlled analgesia, regional anaesthesia techniques, epidural local anaesthetic – narcotic mixtures, cryoanalgesia, transcutaneous electric nerve stimulation, psychological methods. Various opioides intrathecally and epidurally have been tried for post-operative analgesia. These include - morphine, pethidine, pentazocine, methadone, tramadol, Fentanyl, sufentanyl. In present study, we tried to find out analgesic effectiveness of intrathecal Fentanyl for post-operative analgesia, combined with 0.5 % Bupivacaine and side effects if any, in patients undergoing lower limb surgeries. Materials and Methods: After approval from the local ethics committee and with written informed consent from patient, a randomized controlled prospective study is carried out in the medical college and hospital.100 patients belonging to American Society of Anesthesiologists (ASA)classification I &amp; II, aged between 18-60 years, posted for elective lower limb surgeries, were randomly allocated for the study. Group-I: 50 patients received intrathecal 3 ml of 0.5 % hyperbaric Bupivacaine only. Group-II : 50 patients received intrathecal 3 ml of 0.5% hyperbaric Bupivacaine and Fentanyl 25 mcg.The patients studied across the group did not vary much with respect to age,height, weight and sex distribution. Results: The onset of sensory blockade was faster by 1.27 min in Group-BF. The perioperative and postoperative hemodynamic parameters were comparable in both the groups. The sensory analgesia in Group II was significantly prolonged by 159 mins, thus increasing the duration of analgesia. The time of first request of analgesics by the patients in group-II is prolonged compared to group-I thus prolonging the duration of analgesia. Analgesic requirement is also reduced in study group in early post-operative period. The onset of motor block was faster when Fentanyl was added to intrathecal Bupivacaine and it was 1.1 min earlier in study group. The duration of motor block to Bromage III was prolonged by almost 22 min in study group as compare to control group. Visual analogue scores were significantly lower in group-II compared to group-I after two hours of surgery thus reducing the frequency of supplemental postoperative analgesics. Conclusion: With the present study we can summarize that intrathecal Fentanyl potentiates the action of Bupivacaine thereby bringing about better quality and longer duration of analgesia, intense motor block, no hemodynamic disturbance and better postoperative outcome with/ minimum side effects.


2016 ◽  
Vol 8 (1) ◽  
pp. 22-25 ◽  
Author(s):  
KB Prashanth ◽  
S Abhilash

ABSTRACT Objectives This study was conducted to assess the efficacy of the drug tranexamic acid administered preoperatively in controlling the bleeding during tonsillectomy intraoperatively. Materials and methods A total of 50 patients who underwent tonsillectomy were randomized into two groups. Group I (study group): Intravenous tranexamic acid was given with dose of 10 mg/kg. Group II (control group): Tranexamic acid injection was not given. Intraoperative amount of bleeding was assessed in each case. Results The study group had significant reduction in bleeding and the p-value was <0.05, which was statistically significant, when compared to control group. There were no side effects of the drug observed. Conclusion Single intravenous dose of tranexamic acid at a dose of 10 mg/kg preoperatively is effective in control of tonsillectomy bleeding. How to cite this article Santosh UP, Prashanth KB, Abhilash S. A Comparative Study to verify the Efficacy of Preoperative Intravenous Tranexamic Acid in Control of Tonsillectomy Bleeding. Int J Otorhinolaryngol Clin 2016;8(1):22-25.


2011 ◽  
Vol 6 (2) ◽  
pp. 785-789
Author(s):  
NUZHAT AMIN

BACK GROUND: Post partum hemorrhage still remains a major cause of maternal death. Syntocinonis the first line protective measure in this regard. However this is heat sensitive and losses its efficacyafter storage for some time. On the other hand misoprostol do not losses its efficacy for long time afterstorage, is cheap, can be stored at room temperature and give the same result as syntocinon in preventingpostpartum hemorrhage and atonic uterus.OBJECTIVE: To assess the prophylactic use of misoprostol in preventing PPH and management ofatonic uterus, and compare it with conventional i/v syntocinon routinely used in hospitals for cesariondeliveries.MATERIAL AND METHODS: This is a semi experimental study, which was conducted in Mardanmedical complex Hospital Mardan, department of obstetrics and gynecology unit A, between May 2014to May 2015. 200 women have give birth to their babies by C-section were included in the study anddivided into 2 groups, a control group (100 women who received syntocinon) and a study group (100women who received rectal misoprostol). Syntocinon lOu i/v injection and misoprostol 800ug (4tablets)per rectum were given to women in control and study group respectively, immediately after delivery ofthe baby. Blood loss after delivery and frequency of atonic PPH were recorded and compared betweenthe two groups. Side effects of both drugs were also noted.RESULTS: There was no significant difference in blood loss after delivery. Control group 250ml, studygroup 300ml, P value -0.18). The frequency of atonic PPH in study and control groups was similarranging between 3% and 4%.Side effects of misoprostol ( shivering 25% , fever 15% , vomiting 12%and diarrhea 5%) were significant ( P value <0.05 ) but all were temporary and not life threatening.CONCLUSION: Misoprostol can be used for the prevention of PPH and to reduce atonic uterus afterC-section deliveries, especially in poor countries where facilities for storage of oxytocin are notavailable. Benefits of misoprostol outweigh its side effects.Key Words: prophylaxis, atonic postpartum hemorrhage, rectal, misoprostol, syntocinon,underdeveloped countries.


Author(s):  
Malathi T. M. ◽  
Kanchanamalai K.

Background: It is essential to intervene pregnancy for safety of mother, fetus or both. Successful labor induction is clearly related to the state of the cervix. Women with an unfavorable cervix who have not experienced cervical ripening phase before labor present the greatest challenge with regard to labor induction. Therefore, it is necessary to use optimal technique for cervical ripening and safe confinement. One of the common methods includes use of PGE2 gel for cervical ripening. The rationale of this study is to compare the safety and efficacy of Iso-sorbide mononitrate as pre-induction cervical ripening with PGE2 gel induction.Methods: After attaining ethics approval [PSG IHEC], a prospective randomised, case-controlled study was conducted on 182 women undergoing elective induction of labour. They were allocated to either Study or Control group by computer generated random number table method. ISMN was used vaginally prior to labour induction in the study group whereas PGE2 gel induction was used in the control group. Change in bishop score and Induction to delivery interval was assessed in both the groups.Results: There was a significant reduction in induction to delivery interval in the study group (ISMN) 15.2 hours when compared to 23.2 hours in the control group (PGE2 gel) with p=0.000. Need for augmentation of labour was reduced in the study group significantly with p=0.003. Cost of induction was less when compared to the control group. ISMN had less side effects hence can be used as OP basis.Conclusions: Vaginal Isosorbide mononitrate when used as a cervical ripening agent significantly reduces induction to delivery interval. Use of Isosorbide mononitrate was associated with very less side effects and it is a cost-effective drug. Thus, ISMN can be used safely and effectively in term patients for pre-induction cervical ripening when compared to PGE2 gel.


Author(s):  
Anjali Modak ◽  
Harindanath S. Kumar

Background: To compare the analgesic efficacy of transdermal Diclofenac patch (100 mg) with intramuscular Diclofenac sodium (75 mg) for postoperative analgesia and to know the side effects of transdermal Diclofenac patch. Methods: 60 ASA I and II patients, of either sex, aged 15 and above, scheduled for lower limb surgery under subarachnoid block were included in the study. All were allocated randomly by computer generated randomization sheet into two groups of 30 each. Subarachnoid block was administered using 0.5% hyperbaric Bupivacaine. Participants in the study group were applied with a transdermal Diclofenac patch containing 100 mg of Diclofenac diethylamine at the beginning of the surgery. In the control group 75 mg of Diclofenac sodium was given intramuscularly half an hour before the end of surgery. Pain was assessed postoperatively using visual analogue scale. Injection Tramadol 2 mg was administered intramuscularly as rescue analgesia. The data obtained was analyzed using chi - square test and unpaired student’s ‘t’test. Results: The mean time at which rescue analgesia was administered in the control group was 7 hours 28 min and in study group was 20 hours 6min.The time at which rescue analgesics were required in the study group was significantly prolonged (p<0.0001). The amount of Inj. Tramadol required as rescue analgesia in the control group was 189.33 mg. ± 16.38 mg. and in study group it was 97 mg. ± 7.24 mg and this was found to be statistically significant (p<0.0001). When the side effects were compared they were not significant. Conclusions: Based on the results obtained we conclude that, the intraoperative application of 100 mg transdermal Diclofenac diethylamine patch significantly prolongs the time at which patient requires rescue analgesia without any significant side effects. Rescue analgesic requirement was also significantly lower in the study group.


Author(s):  
Yadhuraj M. K. ◽  
Somasekharam P. ◽  
Vinay D. M. ◽  
Akhil Rao U. K.

Background: To evaluate and compare the efficacy of epidurally administered Tramadol. Hydrochloride and Pentazocine Lactate in providing post operative pain relief for lower abdominal and lower limb surgeries. To compare the side effects between epidural tramadol and pentazocine. Design of the study was a prospective randomized study.Methods: The study population consisted of 100 patients aged between 18-65 years posted for various elective lower abdominal and lower limb surgeries requiring neuraxial anaesthesia at M.V.J. Medical College and Research Hospital, Hoskote, Bangalore. The study population was randomly divided into 2 groups with 50 patients in each sub group. Group T: Administered 50mg Tramadol, diluted to 10ml with Normal saline, epidurally (n = 50) Group P: Administered 0.3mg/kg Pentazocine, diluted to 10ml with Normal saline, epidurally (n = 50). Patient was monitored on various parameters including duration of action, hemodynamic variables, and side effects.Results: In group administered 50mg Tramadol epidurally, the mean time to onset of analgesia was 4.36±2.23 mins and the mean time to onset of analgesia in the group administered pentazocine was 4.84±2.24 mins, with a p value of 0.286, which is not considered significant. In tramadol group, the analgesic period averaged 7 hours 20 minutes, while the duration of analgesia in group P averaged 6 hours 43 minutes, with a p value of 0.475, which is not considered significant. It was also observed that 0.3mg/kg of pentazocine produced marginally higher incidence of bradycardia, dizziness, drowsiness.Conclusions: With these results, we conclude that epidural tramadol 50mg gives longer lasting and more profound analgesia with lesser side effects when compared to 0.3mg/kg of pentazocine.


Author(s):  
Varsha P. Gajbhiye ◽  
Y. R. Lamture

Background: Pain associated with venepuncture has long been accepted as an unavoidable consequence. Many studies show reducing pain during venepuncture after application of prilocaine/lignocaine, but there are few studies that has depicted, the depth of anesthesia produced by prilocaine/lignocaine tends to be too superficial for the reducing the pain during venepuncture. These two scenarios were debatable. Therefore, authors planned a study to assess anesthetic potential of lidocaine /prilocaine cream versus placebo before venepuncture with help of VAS in an adult patient who were drawn blood sample for investigation purposes.Methods: Prospective interventional study. All adult patient for blood sampling from surgery OPD to central laboratory were included in study. Site of venepuncture selected in both control and study group was left cubital fossa. 30 patients selected in study group received lignocaine/prilocaine locally, 30min prior to venepuncture which was later covered with occlusive tape, whereas 30 control group patient received normal saline locally as placebo. The extent of pain was assessed by patient on 10cm visual analogue scale (VAS) with end points of 0 cm rated as no pain and the points of 10cm as intolerable pain.Results: A total of 60 patient were randomly selected who were referred from surgery OPD for blood sampling. Other 30 patient were applied normal saline as placebo and 30 patient with lignocaine and prilocaine cream. In the control group there were 30 patients (5 female and 25 male). In the study group there were 30 patients (8 females and 22 males). The level of pain among study group is as follows: mild 22, moderate 7, worst 1 and in control group: no pain 0, mild 5, moderate 14 and worst pain 1. Statistical analysis between outcome of two groups done by calculating chi-square test. Chi- square test was 20.0263. P value is 0.000168. Hence the result is significant at p <0.05.Conclusions: The present study shows that prilocaine-lidocaine cream reduces the pain of needle puncture in adults and facilitates the procedure of venous blood sampling.


Author(s):  
Kumar Shailesh ◽  
Jitendra Prasad Singh ◽  
Arjun Prasad ◽  
Veena Horo

Introduction: Several adjuncts like adrenaline, opioids and alpha-2 adrenergic agonists are being used with local anaesthetics intrathecally for prolongation of intra-operative and post-operative analgesia and to reduce the side-effects of high doses of local anaesthetics. Aim: The present study was done to evaluate the onset and duration of sensory and motor block, hemodynamic effects, post-operative analgesia and adverse effects of Dexmedetomidine given intrathecally with hyperbaric 0.5% Bupivacaine. Materials and methods: Sixty inpatients of ASA class I and II scheduled for various lower abdominal surgeries under Sub-Arachnoid Block were randomly divided into two groups of 30 each namely C (Control), D(Dexmedetomidine) . All received 12.5mg hyperbaric bupivacaine plus 0.5 ml Normal Saline in Group C (Control),10µg Dexmedetomidine (diluted in preservative free Normal saline of 0.5ml) in Group D(Dexmedetomidine) . The onset time to reach peak sensory and motor level, the regression time for sensory and motor block, hemodynamic changes and side-effects were noted. Results: The duration of sensory and motor block, rescue analgesia was significantly prolonged in Dexmedetomidine group when compared to that of Control group. Conclusion: Dexmedetomidine 10 µg seems to be a better neuraxial adjuvant to hyperbaric Bupivacaine. Keywords: Bupivacaine; Dexmedetomidine; intrathecal.


Author(s):  
Basavaraj Kallapur ◽  
Yashavanthi H. S. ◽  
Safiya I. Sheikh

Background: Studies comparing the efficacy of dexmedetomidine and clonidine as adjuvants to ropivacaine 0.75% in spinal anesthesia are few. The objective was to study the safety and efficacy of dexmedetomidine in comparison to clonidine as an adjuvant to ropivacaine in subarachnoid block.Methods: Patients were randomly allotted into 3 groups. Group R (n=30) patients received 3ml of 0.75% isobaric ropivacaine +0.5ml of 0.9% normal saline to a total volume of 3.5ml. Group RD (n=30) patients received 3ml of 0.75% isobaric ropivacaine +5μg of dexmedetomidine +0.9% normal saline to a total volume of 3.5ml. Group RC (n=30) patients received 3ml of 0.75% isobaric ropivacaine +30μg of clonidine +0.9% normal saline to a total volume of 3.5ml. The patients and the investigator were blinded for the study.Results: Time to reach T10 level of sensory block in group R was 7.6±1.3 min, group RC was 7.8±1.4 min and in group RD it was 7.9±1.4 min which was statistically not significant with p value 0.66. Time to reach motor onset to Bromage scale 4 was 9.8±1.4 min in group R, 10±1.4 min in group RC, 10.5±1.5 min in group RD which was statistically not significant with p value 0.24. Time to reach maximum sensory block in group R was 10.7±1.4 min, 10.6±1.1 min in group RC, 11±1.7 min in group RD which was statistically insignificant with p value 0.51.Conclusions: Intrathecal dexmedetomidine had superior anaesthetic effects with respect to duration of sensory blockade, motor blockade and duration of analgesia compared to intrathecal clonidine.


2021 ◽  
pp. 105566562110128
Author(s):  
Jason R. Stein ◽  
Esperanza Mantilla-Rivas ◽  
Marudeen Aivaz ◽  
Md Sohel Rana ◽  
Ishwarya Shradha Mamidi ◽  
...  

Objective: To analyze safety and efficacy of single-dose ketorolac after primary palatoplasty (PP). Design: Consecutive cohort of patients undergoing PP, comparing to historical controls. Setting: A large academic children’s hospital. Patients, Participants: A consecutive cohort of 111 patients undergoing PP (study n = 47) compared to historical controls (n = 64). Interventions: All patients received intraoperative acetaminophen, dexmedetomidine, and opioids while the study group received an additional single dose of ketorolac (0.5 mg/kg) at the conclusion of PP. Main Outcome Measures: Safety of ketorolac was measured by significant bleeding complications and need for supplementary oxygen. Efficacy was assessed through bleeding, Face Legs Activity Cry Consolability (FLACC) scale, and opioid dose. Results: Length of stay was similar for both groups (control group 38.5 hours [95% CI: 3.6-43.3] versus study group 37.6 hours [95% CI: 31.3-44.0], P = .84). There were no significant differences in all postoperative FLACC scales. The mean dose of opioid rescue medication measured as morphine milligram equivalents did not differ between groups ( P = .56). Significant postoperative hemorrhage was not observed. Conclusions: This is the first prospective study to evaluate the safety and efficacy of single-dose ketorolac after PP. Although lack of standardization between study and historical control groups may have precluded observation of an analgesic benefit, analysis demonstrated a single dose of ketorolac after PP is safe. Further investigations with more patients and different postoperative regimens may clarify the role of ketorolac in improving pain after PP.


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