NCT04446715

Brief Summary

Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged. In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

June 19, 2020

Last Update Submit

July 28, 2021

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • First analgesic request time

    The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand

    24 hours post operatively

Secondary Outcomes (1)

  • Analgesic requirements

    24 hours post operatively

Study Arms (2)

Sufentanil Group

EXPERIMENTAL

Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia

Drug: sufentanilDrug: Bupivacaine

Meperidine Group

EXPERIMENTAL

Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia

Drug: meperidineDrug: Bupivacaine

Interventions

sufentanilDRUG

Patients will receive sufentanil in spinal anesthesia

Sufentanil Group
meperidineDRUG

Patients will receive meperidine in spinal anesthesia

Meperidine Group
BupivacaineDRUG

Patients will receive 0.5% heavy bupivacaine in spinal anesthesia

Meperidine GroupSufentanil Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women with American Society of Anesthesiologist (ASA) 2-3
  • scheduled for elective cesarean section.

You may not qualify if:

  • refuse to participate in the study,
  • requiring emergency obstetric care,
  • ASA IV or V,
  • having systemic diseases,
  • a known fetal anomaly,
  • placenta previa,
  • abruption placenta
  • with a history of hypersensitivity or allergy to any of the study drugs,
  • operation time longer than 1.5 hour,
  • blood loss more than 1500 millilitres,
  • those with any contraindication to the technique proposed,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

Related Publications (1)

  • Kanawati S, Barada MA, Naja Z, Rajab O, Sinno L, El Hasan J. Comparison of clinical effects of meperidine and sufentanil added to 0.5% hyperbaric bupivacaine for spinal anesthesia in patients undergoing cesarean delivery: a randomized controlled trial. J Anesth. 2022 Apr;36(2):201-209. doi: 10.1007/s00540-021-03031-6. Epub 2022 Jan 27.

    PMID: 35083557DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

SufentanilMeperidineBupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsonipecotic AcidsAcids, HeterocyclicAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Saleh Kanawati, MD

    Makassed General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh Kanawati, MD

CONTACT

+9611636000s.kanawati@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Acting chairperson

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 25, 2020

Study Start

October 1, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

July 30, 2021

Record last verified: 2021-07

Locations

LE(1)