Meenatchi, R (2010) Prospective Randomized Trial on Effect of Adding Clonidine to Hyperbaric Bupivacaine Intrathecally in Patients Posted for Caesarean Section. Masters thesis, Madras Medical College, Chennai.
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Abstract
INTRODUCTION: Caesarean section is one of the commonest surgeries performed. Unlike most surgical patients, many parturients express the desire to be awake and alert during and after childbirth. The recovery should be compatible with the initial newborn bonding and frequent feeding. The role of Obstetric Anaesthesiologist has been enhanced to include providing safe and satisfying postoperative pain relief to the parturient. The advantages of spinal anaesthesia in caesarean section include; • the simplicity of the technique. • rapid onset of anaesthesia. • less neonatal exposure to potentially depressant drugs. • decreased risk of maternal pulmonary aspiration. • awake mother at the birth of the child. • Option of using additives to local anaesthetics for postoperative pain relief. Bupivacaine was introduced by Eckenstam in 1957 and used clinically by Telivuo in 1963. Although Intrathecal Bupivacaine alone offers blockade upto T5 dermatome, a substantial number of patients still experience some pain or discomfort and require analgesic supplement during Caesarean delivery. Addition of α2 adrenergic agonist Clonidine to Bupivacaine has a variety of actions • potentiates the effects of local anaesthetic • improves the quality of intraoperative anaesthesia • prolongs the sensory blockade and reduces the requirement of postoperative analgesics • Does not produce pruritus and respiratory depression unlike spinal opioids. This study was designed to evaluate the efficacy and adverse effects of 75μg Clonidine added to 0.5% Hyperbaric Bupivacaine administered intrathecally in patients undergoing elective Caesarean section. AIM OF THE STUDY: This study aims to evaluate the effects of addition of Clonidine, an alpha -2 agonist to 0.5%Hyperbaric Bupivacaine administered intrathecally in patients posted for elective caesarean section comparing with a placebo. (Normal saline). MATERIALS AND METHODS: This study was conducted at the Institute of Obstetrics and Gynaecology, Madras medical College, Egmore, Chennai. Between January 2009 - March 2009 on 100 Patients of ASA Physical status I and II undergoing elective Caesarean Section. This study was done after ethical committee approval and written informed Consent obtained from all the Patients included in this study. STUDY DESIGN: This study was done in a prospective, double blind randomized manner. Each group consisted of fifty patients. Group BC - Patients in this group received 2ml of 0.5% Hyperbaric Bupivacaine + 75μg (0.5ml) of preservative free Clonidine to a total volume of 2.5 ml intrathecally. Group BN - Patients in this group received 2ml of 0.5% Hyperbaric Bupivacaine + 0.5 ml of normal saline intrathecally. The final volume of injected solution was 2.5ml in both groups. In this study 0.5% Hyperbaric Bupivacaine in 8% Dextrose manufactured by NEON Labs Ltd, Thane, and Clonidine hydrochloride (CLONEON) 150μg/ml manufactured by NEON Labs Ltd, Thane and Normal Saline manufactured by HASEEB pharmaceuticals Ltd, Nagpur were used. All the solutions were prepared under strict aseptic precautions, by the OT in charge anaesthesiologist uninvolved in the administration of SAB or in the Observation of results. The specific gravity of the injected solution is 1.025, 1.211 in group BC and BN respectively. All the solutions were hyperbaric relative to CSF. SELECTION OF CASES: Inclusion criteria: 1. ASA Physical status I & II. 2. Age between 18 – 35 years. 3. Height 145 – 160cm. 4. Patients who have given valid Informed consent. 5. Singleton fetus at term. Exclusion criteria: 1. Not satisfying inclusion criteria. 2. Age < 18 or > 35. 3. Preterm. 4. Hypertensive disorders of Pregnancy. 5. Cardio vascular, Neurological, Hepatic or Renal disease. 6. Known Hypersensitivity to the Study drug. 7. Contraindication to SAB. 8. Opioid exposure during pregnancy. 9. Unconscious, or severely ill Patients. OBSERVATION AND RESULTS: This study was conducted at the Institute of Obstetrics and Gynaecology, Egmore, Chennai. 100 patients were included in this double blinded randomized controlled study. The patients were divided in to two groups. Patients in group BC received 2ml (10mg) of 0.5% hyperbaric Bupivacaine plus 0.5ml (75μg) of Clonidine. Patients in group BN received 2ml (10mg) of 0.5% hyperbaric Bupivacaine plus 0.5ml of normal saline. Final volume of injected solution was 2.5ml in both groups. SUMMARY: This double blinded prospective randomized controlled trial was designed to evaluate the efficacy of 75 μg (0.5ml) Clonidine added to 10 mg (2ml) of 0.5% hyperbaric Bupivacaine intrathecally, in patients aged 18- 35years undergoing elective caesarean section. Patients receiving 0.5ml of normal saline with 2ml of Bupivacaine intrathecally served as the control. The following observations were made. • The addition of Clonidine significantly prolonged the two segment Regression time. • The addition of Clonidine significantly prolonged the duration of effective surgical analgesia. • The addition of Clonidine significantly prolonged the sensory block and motor block. • The addition of Clonidine significantly prolonged the duration of time for demand analgesia. • The addition of Clonidine intrathecally had no effect on the onset of sensory and motor block. • The incidence of side effects was limited to the occurrence of hypotension, bradycardia and sedation in the groups that received Clonidine intrathecally. • Addition of Clonidine did not have any effect on the fetal APGAR score. • Addition of Clonidine decreased the intra operative and post operative shivering. • Addition of Clonidine decreased the intra operative nausea and vomiting. CONCLUSION: This study confirms the efficacy of 75μg of Clonidine as a safe and effective adjuvant to 0.5% hyperbaric Bupivacaine in subarachnoid block for caesarean section. The addition of 75 μg of Clonidine to 2 ml of 0.5% hyperbaric Bupivacaine improved the quality of surgical anaesthesia. Clonidine 75 μg added to 10mg of 0.5% hyperbaric Bupivacaine intrathecally prolonged post operative analgesia and reduces the post operative analgesic requirements.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Clonidine ; Hyperbaric Bupivacaine Intrathecally ; Patients ; Caesarean Section ; Prospective Randomized Trial. |
| Subjects: | MEDICAL > Anaesthesiology |
| Depositing User: | Subramani R |
| Date Deposited: | 21 Apr 2018 15:59 |
| Last Modified: | 21 Apr 2018 15:59 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/7200 |
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