A study to assess the rate of occurence of nausea and vomiting followed by the addition of the drug morphine given as apart of anaesthesia for patients with carcinoma cervix undergoing high dose (HDR) intracavitary brachytherapy.

Not yet recruiting

• Conditions: Malignant neoplasm of cervix uteri, unspecified,

• Registration Number: CTRI/2020/06/025687
• Lead Sponsor: Christian MedicalCollegeVellore

Brief Summary

Women diagnosed with stages I, II and III cervical cancer are treated with chemo-radiation (pelvic external-beam radiation, weekly cisplatin chemotherapy and HDR cervical brachytherapy).

Patients are given anaesthesia during the inpatient brachytherapy procedure that lasts 1 day. In our institution, morphine is used as the intrathecal anaesthetic for pain relief in these patients.

Patients who give informed consent will be recruited for this study.

As per routine practice, spinal anaesthesia with intrathecal morphine will be given as analgesic for brachytherapy.

Patients will be monitored for hemodynamic variables like Heart rate, Blood pressure, Oxygen saturation( SpO2 ) throughout the procedure and also in the recovery room.

Patients will be assessed for i)Nausea and vomiting, ii)need for anti emetics, iii) pain score, iv)need for rescue analgesia,v)sedation score, vi)pruritus and respiratory depression in the recovery room as well as in the

postoperative ward.

Nausea and vomiting will be assessed by nausea vomiting score (0 = No nausea , 1 = Nausea, 2 = Retching, 3=Vomiting)

Pain will be assessed by visual analogue scale ( VAS : 0 to 10 scale in which 0 = no pain, 10 = maximum pain).

Sedation will be assessed by Ramsay sedation score (RSS: 1=Anxious, agitated, restless, 2= Co operative, oriented, tranquil, 3=Responds to command only, 4 = Asleep, brisk response to stimulus,5 = Asleep, sluggish response to stimulus, 6 = Un arousable).

A respiratory rate of < 8 breaths/minute and oxygen saturation of <92% will be taken as respiratory depression

The total dose of opioids administered, the first time of rescue analgesic administered, antiemetics given will be noted and analysed.

The study hypothesis is that intrathecal morphine is a good analgesic with no side effects in patients undergoing Brachytherapy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-06-06
• Study Start: 2020-08-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 1. Histologically proven carcinoma cervix for intracavitary brachytherapy.
• 2. ASA I/II 3) Consent for participation in study.

Exclusion Criteria

1. Patient undergoing treatment for chronic pain 2) Preoperative history of nausea and vomiting requiring treatment 3) Unfit for spinal anaesthesia like Coagulopathy, cardiac lesions, infection at the site of spinal injection, fever 4) Unwilling or unable to give consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
among patients coming for HDR Brachytherapy for carcinoma cervix	With in 24 hours
Incidence of nausea and vomiting following intrathecal morphine	With in 24 hours

Secondary Outcome Measures

Name	Time	Method
i) Duration of analgesia with intrathecal morphine which will be measured by	the time to first rescue analgesic

Trial Locations

Locations (1)

ChristianMedicalCollege,Vellore; 🇮🇳 Vellore, TAMIL NADU, India

ChristianMedicalCollege,Vellore

🇮🇳Vellore, TAMIL NADU, India

Divya Isac

Principal investigator

9443000580

divyaishac@gmail.com