Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section

September 5, 2020 updated by: Dr. Amr Aly Ismail Keera, Dr. Soliman Fakeeh Hospital

Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids. Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in postpartum patients and 69% in non-pregnant patients including males and females (1). Some researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and effective way to reduce the incidence and severity of hypotension during cesarean section under spinal anesthesia (2). In this new research I want to investigate the effect of slow injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence of itching In this double blind randomized study two hundred parturient will be randomly allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will be those with allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Parturient will be monitored regarding the incidence of itching, hypotension, nausea and vomiting. Onset and level of sensory block will also be recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Elective and emergency cesarean section parturient.

Exclusion Criteria:

  • Allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (R) Rapid spinal fentanyl injection
Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds then 10 mg hyperbaric bupivacaine.
Drug: (R) Rapid spinal fentanyl injection
Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 20 seconds then 10 mg hyperbaric bupivacaine.
Active Comparator: (S) Slow spinal fentanyl injection
Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
Drug: (S) Slow spinal fentanyl injection
Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
( 0 - 10) Itching scale
Time Frame: 60 min
60 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia
Time Frame: 60 min
60 min

Other Outcome Measures

Outcome Measure
Time Frame
Hypotension ( yes or no)
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Soliman Fakeeh Hospital

Investigators

  • Principal Investigator: Amr A Keera, Doctor Soliman Fakeeh Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 29, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 5, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/IRB/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

I hope to publish the data in a respected journal.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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