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

Sponsor

Dr. Soliman Fakeeh Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02951806

Collaborator

(none)

215

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Itching	Drug: (R) Rapid spinal fentanyl injection Drug: (S) Slow spinal fentanyl injection	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

215 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

( 0 - 10) Itching scale [60 min]

Secondary Outcome Measures

Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia [60 min]

Other Outcome Measures

Hypotension ( yes or no) [60 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dr. Soliman Fakeeh Hospital

Investigators

Principal Investigator: Amr A Keera, Doctor Soliman Fakeeh Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Amr Aly Ismail Keera, Prof. Amr Aly Keera, Dr. Soliman Fakeeh Hospital

ClinicalTrials.gov Identifier:

NCT02951806

Other Study ID Numbers:

02/IRB/2016

First Posted:

Nov 1, 2016

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Pruritus

Fentanyl

Study Results

No Results Posted as of Sep 9, 2020