Spin?l m?rphine f?r p?st?per?tive ?n?lgesi? - safety and effectiveness depending on doses

Not Applicable

Completed

• Conditions: Outcomes after different spinal morphine doses for patients undergoing hip replacement surgery; Surgery

• Registration Number: ISRCTN37212222
• Lead Sponsor: niversity of Latvia

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36471258/ (added 06/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-05-02
• Study Start: 2022-04-20
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patient is scheduled for total hip replacement under spinal anaesthesia
2. Aged 18-80 years
3. Body mass index (BMI) <35 kg/m²
4. ASA Physical Status Classification System < IV

Exclusion Criteria

1. Patient rejection
2. Drug allergy to medications included in this study
3. Severe respiratory disorders
4. BMI >35 kg/m²
5. Patient is not able to understand the main points of the research
6. Patient is enrolled in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Pain measured using the numeric rate scale (NRS) at baseline, 4, 7, 12, ?nd 24 hours<br> 2. Respiratory rate (x/min) measured using a vital sign monitor in the postoperative recovery room at baseline, 4, 7, 12, ?nd 24 hours<br> 3. Arterial blood oxygen saturation (Sp?2,%) measured using a vital sign monitor in the postoperative recovery room at baseline, 4, 7, 12, ?nd 24 hours<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. M?rphine 10 mg s/? is injected by a nurse on patient request if pain is more than 5 points (by NRS), each injected dose is noted by a nurse in the narcotic drug copy-book and ??nsumpti?n is counted in 24 h by the researcher and noted in the research protocol<br> 2. Additional oxygen consumption: time (min) and speed (l/min) of additional oxygen supply. The period of time when the patient has inhaled additional oxygen and the speed (l/min) of the supply is noted in the patient observation form by a nurse and in the research protocol by the researcher.<br> 3. The incidence of any adverse reactions (n?use?, v?miting, it?hing, urine retention) measured using a formula (incidence = cases/total number of patients in the research group). The case of each adverse reaction is noted by a nurse in the patient observation form during 48 h after surgery.<br>