Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section

Study Overview
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Brief Summary
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This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.

Official Title
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Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section

Conditions
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Non Elective Cesarean Section and Ketamine Analgesia

Intervention / Treatment
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* Drug: Ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All women at term(>or =37 weeks of gestation) Healthy American Society of Anesthesiologists(ASA) class1 and 2 Women undergoing non-elective caesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and fentanyl Exclusion Criteria: • Women with American society of anesthesiologist physical status>2 Body mass index >or =40 kg per square meter Height <150 cm Any contraindication to the spinal anesthesia History of substance abuse History of hallucinations Chronic opioid therapy Chronic pain or on any pain medication currently Patient with maternal complications,like cardiovascular disease pre-eclampsia,diabetes,multiple gestation,known fetal abnormality Cases with severely compromised fetus where immediate administration of general anesthesia is required.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: analgesic effects of ketamine<br>the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision. | Drug: Ketamine<br>* the analgesic affects of ketamine will be compared between the experimental and placebo group.<br>* Other names: ketamine hydrochloride;|
| Placebo Comparator: placebo<br>they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision. | Drug: Placebo<br>* the analgesic requirement will be calculated in placebo group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid requirement postoperatively | Total opioid required up to 24 postoperatively in ketamine and placebo group. | 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative ) | • Postoperative NRS Scores (on arrival to Post operative care unit), 2, 4, 6, 8, 12 and 24 h ).The NRS ranges from 0- 10 and 0 refers to no pain and 10 means extreme possible pain perceived. | 24 hrs | 
| Time to first perception of pain | Time to first perception of pain | 24 hrs | 
| Incidence of side effects | Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h | 24 hrs |