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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04589429
Other study ID # 678-9/2020
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 15, 2020
Est. completion date March 2021

Study information

Verified date February 2021
Source Minia University
Contact Sohair A Megalla, MD
Phone +20 120 003 6447
Email Sohair.Adeeb@minia.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia.


Description:

The study will be performed in MiniaUniversity Hospitals, after obtaining approval from the local ethics committee. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. Patients undergoing major abdominal surgery will be divided into 2 groups to receive intrathecal morphine 300 micrograms with or without nalbuphine 1mg prior to anesthesia. General anesthesia is then given to patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date March 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Male and female patients. - Age 18-80yrs. - Elective major abdominal surgery under general anesthesia. Exclusion Criteria: - Refusal to participate. - Skin or systemic disease with itching. Any condition which precludes performing spinal injection

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine 10 MG/ML
intrathecal morphine 300 micrograms
Nalbuphine Hydrochloride 10 MG/ML
intrathecal nalbuphine 2mg.

Locations

Country Name City State
Egypt anesthesia&ICU department Minya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary pruritus Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus). 2 hours postoperatively
Primary pruritus Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus). 4 hours postoperatively
Primary pruritus Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus). 24 hours postoperatively
Secondary postoperative pain assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain 2 hours postoperative
Secondary postoperative pain assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain 4 hours postoperative
Secondary postoperative pain assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain 24 hours postoperative
Secondary postoperative nausea and vomiting four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting 2 hours postoperative
Secondary postoperative nausea and vomiting four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting 4 hours postoperative
Secondary postoperative nausea and vomiting four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting 24 hours postoperative
Secondary Sedation four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation). 2 hours postoperative
Secondary Sedation four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation). 4 hours postoperative
Secondary Sedation four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation). 24 hours postoperative
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