NCT05943613

Brief Summary

The delivery of the infant into the arms of a conscious and pain free mother is one of the most exciting and rewarding moments in medicine. Neuraxial anesthesia is now the preferred technique for lower segment cesarean sections (LSCS). Although epidural, spinal, continuous spinal, and combined spinal-epidural techniques have all been advocated, most cesarean sections are performed under single-shot spinal anesthesia. Even when a long acting local anesthetic like bupivacaine is used, the duration of spinal anesthesia (SA) is short and higher doses of analgesics are required in the postoperative period. Therefore, achieving a subarachnoid block that provides high quality postoperative analgesia of consistently prolonged duration is an attractive goal.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P75+ for phase_1 postoperative-pain

Timeline
Completed

Started Dec 2023

Longer than P75 for phase_1 postoperative-pain

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

June 7, 2023

Last Update Submit

July 5, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative analgesic efficacy of intrathecal clonidine and neostigmine by use of numerical rating scale (NRS) pain score.

    using numerical rating scale (NRS) pain score that ranges from 0 indicating no pain up to 10 indicating the worst pain

    2 hours after time of sensory block

Study Arms (3)

Group B

PLACEBO COMPARATOR

control group : will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing 1 ml of Dextrose 5%.

Drug: Clonidine

Group BC

ACTIVE COMPARATOR

will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing Clonidine (30 µg) diluted in Dextrose 5% to a total volume of 1 ml.

Drug: Clonidine

Group BN

ACTIVE COMPARATOR

will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing Neostigmine (10 µg) diluted in Dextrose 5% to a total volume of 1 ml.

Drug: Clonidine

Interventions

ClonidineDRUG

compare the effect of intrathecal Clonidine and Neostigmine as adjuvants to Bupivacaine in elective cesarean section

Group BGroup BCGroup BN

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: ranges from 20 - 35 years old.
  • ASA physical status II.
  • Singleton fetus at term.
  • Parturient scheduled for elective lower segment cesarian section under spinal anethesia

You may not qualify if:

  • Patient refusal.
  • Contraindications to spinal blockade, such cardiorespiratory problems, coagulopathy, neurological disease, psychological troubles, and allergy to the used drugs.
  • Morbid obesity.
  • Failure of spinal blockade.
  • Emergency CS.
  • Complicated pregnancy.
  • Intrauterine fetal compromise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

yasser mamdouh hassan, assistant lecturer

CONTACT

01090433083yassermamdouh486@aun.edu.eg

ahmed mohamed abbas, assistant professor

CONTACT

01003385183ahmedabbas@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
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
Assistant lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

June 7, 2023

First Posted

July 13, 2023

Study Start

December 1, 2023

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

July 13, 2023

Record last verified: 2023-07