NCT06088420

Brief Summary

comparing analgesic efficacy of different nerve blocks on post operative cesarean sections.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

October 10, 2023

Last Update Submit

April 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Duration of analgesia until first analgesic request.

    the time interval from immediate postoperative period until NRS reached 4

    24 hours .

Study Arms (3)

Intrathcal Morphine Group

ACTIVE COMPARATOR

Intrathecal morphine administration for post operative pain relief after cesarean section

Procedure: Intrathcal Morphine Group

Quadratus Lumborum nerve block group

ACTIVE COMPARATOR

Quadratus Lumborum nerve block administration for post operative pain relief after cesarean section

Procedure: Quadratus Lumborum nerve block(QL) group

Erector Spinae nerve block group

ACTIVE COMPARATOR

Erector Spinae nerve block administraion for post operative pain relief after cesarean section

Procedure: Erector Spinae nerve block (ESP)group

Interventions

intrathecal morphine (150 μg) in addition to standard spinal anesthetic drugs(10-12 mg 0.5% hyperbaric bupivacaine)

Intrathcal Morphine Group

intrathecal morphine (150 μg) in addition to standard spinal anesthetic drugs (10-12 mg 0.5% hyperbaric bupivacaine) + bilateral QL block by injecting 20 ml of 0.25% isobaric bupivacaine bolus with 4 mg ) dexamethasone as an adjuvant

Quadratus Lumborum nerve block group

intrathecal morphine (150 μg) in addition to standard spinal anesthetic drugs (10-12 mg 0.5% hyperbaric bupivacaine) + bilateral ESP block by injecting 20 ml of 0.25% isobaric bupivacaine bolus with 4 mg ) dexamethasone as an adjuvant

Erector Spinae nerve block group

Eligibility Criteria

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

You may qualify if:

  • years old
  • more or equal 37 weeks of gestation
  • ASA 1,2
  • Elective cesarean delivery

You may not qualify if:

  • Patient refusal
  • inability to cooperate with or understand the study
  • local infection.
  • bleeding disorder
  • known anaphylaxis to any drug used in the trial
  • ASA physical status more than 2
  • emergency operations
  • chronic opioid use (opioid use in the past 3 months)
  • Neurologic deficit or disorder
  • contraindication to regional anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Mamdouh Ekram

Asyut, Manfalout, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Central Study Contacts

Ghada Abo Elfadl, MD

CONTACT

Ghada Abo Elfadl

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator.

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 18, 2023

Study Start

October 15, 2023

Primary Completion

April 5, 2025

Study Completion

April 5, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations