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

B.P. Koirala Institute of Health Sciences80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non Elective Cesarean Section and Ketamine Analgesia

Interventions

KetamineDRUG

the analgesic affects of ketamine will be compared between the experimental and placebo group.

PlaceboDRUG

the analgesic requirement will be calculated in placebo group.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, Nepal

Outcomes

Primary Outcomes

Total opioid requirement postoperatively

Total opioid required up to 24 postoperatively in ketamine and placebo group.

Time frame: 24 hrs

Secondary Outcomes

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.

Time frame: 24 hrs

Time to first perception of pain

Time frame: 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

Time frame: 24 hrs

Data from ClinicalTrials.gov

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