NCT03918187

Brief Summary

Adequate pain management is important to facilitate the functional recovery and enable the patients for rapid rehabilitation of normal activity . Various adjuvants were being used with intrathecal bupivacain to prolong \& improve postoperative pain relief in patients undergoing cesarean section . The aim of this study was to compare intrathecal nalbuphine versus intrathecal midazolam in patient undergoing cesarean section. The investigators primary aims were to compare the characteristics of sensory and motor block, the effective analgesic time, and analgesic requirement. Secondary aims were to compare the side effects, sedation score and apgare score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

April 7, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

April 7, 2019

Last Update Submit

December 19, 2019

Conditions

Cesarean Section Pain

Keywords

nalbuphinemidazolam

Outcome Measures

Primary Outcomes (4)

  • Effective analgesic time

    the time start from intrathecal injection to the first analgesic dose.

    up to six hours postoperative

  • Total postoperative analgesic dose .

    the analgesic dose consumed

    24 hours

  • Onset of sensory and motor block

    the time of onset of sensory and motor block

    up tp five minutes after intrathecal injection

  • duration of sensory and motor block

    the time of duration of sensory and motor block

    up to five hours postoperative

Secondary Outcomes (3)

  • Sedation score

    one hour during surgery

  • Apgar score

    1-5 minutes after delivery

  • number of participants with hypotension , bradycardia ,vomiting , nausea , shivering number of participants with hypotension , bradycardia ,vomiting , nausea , shivering

    up to 24 hours postoperative

Study Arms (3)

bupivacaine

EXPERIMENTAL

12.5 mg hyperbaric bupivacaine + 0.5 ml 0.9% normal saline .

Drug: Bupivacaine

nalbuphine

ACTIVE COMPARATOR

12.5 mg hyperbaric bupivacaine + 1 mg nalbuphine add in 0.5 ml 0.9% normal saline.

Drug: Nalbuphine

midazolam

ACTIVE COMPARATOR

12.5 mg hyperbaric bupivacaine + 2.5 mg midazolam .

Drug: Midazolam

Interventions

BupivacaineDRUG

compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .

bupivacaine
NalbuphineDRUG

compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .

nalbuphine
MidazolamDRUG

compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .

midazolam

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female gender .
  • Age : 18 - 40 years old .
  • Physical status : ASA II .
  • Elective cesarean section

You may not qualify if:

  • \- Patient refusal .
  • History of hypertension or cardiac diseases .
  • Psychiatric disorders .
  • Coagulopathy .
  • Allergy to study drugs .
  • Contraindication to spinal anesthesia .
  • Failure of spinal anesthesia .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olfat Abd Elmoniem Ibrahem Amin

Zagazig, Eygpt/zagazig, 002055, Egypt

Location

Related Publications (1)

  • Amin OAI, Ibrahem MA, Salem DAE. Nalbuphine versus Midazolam as an Adjuvant to Intrathecal Bupivacaine for Postoperative Analgesia in Patients Undergoing Cesarean Section. J Pain Res. 2020 Jun 11;13:1369-1376. doi: 10.2147/JPR.S242545. eCollection 2020.

    PMID: 32606903DERIVED

MeSH Terms

Interventions

BupivacaineNalbuphineMidazolam

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-Ring

Study Officials

  • Olfat A I Amin, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Controlled comparative Double blind randomized study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 7, 2019

First Posted

April 17, 2019

Study Start

April 10, 2019

Primary Completion

August 30, 2019

Study Completion

December 1, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Locations

EG(1)