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

NCT03450499 | Completed Phase 4

• 1 other identifier: IRC/1089/017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Elective Cesarean Section and Ketamine Analgesia

Outcome Measures

Primary Outcomes (1)

• Total opioid requirement postoperatively

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

  24 hrs

Secondary Outcomes (3)

• Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )

  24 hrs

• Time to first perception of pain

  24 hrs

• Incidence of side effects

  24 hrs

Study Arms (2)

analgesic effects of ketamine

EXPERIMENTAL

the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.

Drug: Ketamine

placebo

PLACEBO COMPARATOR

they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.

Drug: Placebo

Interventions

Ketamine DRUG

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

Also known as: ketamine hydrochloride

analgesic effects of ketamine

Placebo DRUG

the analgesic requirement will be calculated in placebo group.

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, 56700, Nepal

Location

Related Publications (1)

• Adhikari P, Subedi A, Sah BP, Pokharel K. Analgesic effects of intravenous ketamine after spinal anaesthesia for non-elective caesarean delivery: a randomised controlled trial. BMJ Open. 2021 Jun 30;11(6):e044168. doi: 10.1136/bmjopen-2020-044168.

  PMID: 34193480 DERIVED

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: March 1, 2018
• Study Start: April 1, 2018
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)