Intrathecal Midazolam, Fentanyl and Nalbuphine as Adjuvants to Bupivacaine in Spinal Anesthesia for Cesarean Section

NCT04932083 | Completed

• 1 other identifier: RC6-5-2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main limitations of spinal anesthesia are its short duration of action and do not provide prolonged postoperative analgesia when it is performed only with local anesthetics. Adding adjuvants drugs to intrathecal local anesthetics improves quality and duration of spinal blockade, and prolongs postoperative analgesia. It is also possible to reduce dose of local anesthetics, as well as total amount of systemic postoperative analgesics.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Duration of effective analgesia

  it is the time interval from the subarachnoid block to the first analgesic intervention (VAS \>3)

  24 hours postoperative

Secondary Outcomes (6)

• The onset of sensory block:

  2 minutes for ten minutes, every 5 minutes for the next 20 minutes after intrathecal injection

• Duration of complete sensory block:

  12 hours postoperative

• Onset of complete motor blockade

  every 2 minutes for 10 minutes after intrathecal injection

• Duration of motor block:

  6 hours postoperative

• Total dose of analgesic consumption

  24 hours postoperative

Study Arms (4)

Bupivacaine

PLACEBO COMPARATOR

patients will receive 2.5 ml of 0.5% hyperbaric bupivacaine (12.5 mg) plus 0.5 ml sterile water.

Drug: Bupivacaine

Fentanyl

EXPERIMENTAL

patients will receive 2.5 ml of 0.5% hyperbaric bupivacaine (12.5 mg) plus 0.5 ml fentanyl (25µg).

Drug: Fentanyl

Nalbuphine

EXPERIMENTAL

patients will receive 2.5 ml of 0.5% hyperbaric bupivacaine (12.5 mg) plus 0.8 mg nalbuphine hydrochloride in 0.5 ml sterile water.

Drug: Nalbuphine

Midazolam

EXPERIMENTAL

patients will receive 2.5 ml of 0.5% hyperbaric bupivacaine (12.5 mg) plus 2mg of midazolam in 0.5 ml sterile water.

Drug: Midazolam

Interventions

Bupivacaine DRUG

patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle. patients will receive the local anesthetic dose of 0.5% heavy bupivacaine (12.5 mg) and 0.5 ml of sterile water will be added.

Bupivacaine

Fentanyl DRUG

patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle. patients will receive the local anesthetic dose of 0.5% heavy bupivacaine (12.5 mg) and 0.5 ml of fentanyl (25µg) will be added.

Fentanyl

Nalbuphine DRUG

patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle. patients will receive the local anesthetic dose of 0.5% heavy bupivacaine (12.5 mg) and 0.8 mg nalbuphine hydrochloride in 0.5 ml sterile water will be added.

Nalbuphine

Midazolam DRUG

patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle. patients will receive the local anesthetic dose of 0.5% heavy bupivacaine (12.5 mg) and 0.4 ml of midazolam (2mg) + 0.1 ml of sterile water will be added.

Midazolam

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: full term parturients undergo elective cesarean section,
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I and ASA II
• Age from 18-40 years
• Scheduled to undergo elective cesarean section under spinal anesthesia.

You may not qualify if:

• ASA physical status III or IV patients.
• Patients refuse spinal anesthesia.
• Patients physically dependent on narcotics or benzodiazepine.
• Patients with history of drug allergy to one of used adjuvants.
• Patients with gross spinal abnormality, localized skin sepsis, hemorrhagic diathesis or neurological involvement/ diseases and any contraindication for spine.
• Patients who are unable to communicate.
• Morbid obesity.
• Failure of spinal blockade.
• Complicated pregnancy.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine; Fentanyl; Nalbuphine; Midazolam

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 18, 2021
• Study Start: June 20, 2021
• Primary Completion: January 14, 2022
• Study Completion: February 24, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)