NCT05276206

Brief Summary

Approximately 1 in 5 women who undergo CS will experience severe acute postoperative pain. The severity of pain in the acute postoperative period is a significant predictor for the development of chronic pain, which occurs in 9.2%-18% of women who undergo CS. Furthermore, severe acute post-cesarean pain triples a woman's risk of developing postpartum depression and negatively affects breastfeeding and infant care. For these reasons, it is imperative to provide adequate postoperative analgesia in this patient population

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

13 days

First QC Date

February 20, 2022

Last Update Submit

July 6, 2023

Conditions

Post Operative PainCesarean Section Pain

Outcome Measures

Primary Outcomes (1)

  • Post Operative Pain

    The pain level of the cases is evaluated by means of the digital pain (numeric rating) scale from 0 to 10 in which 0 means "no pain" and 10 means "the worst pain" as well as the duration of pain relief

    2 hours after the Cesarean Section till the pain relief

Study Arms (4)

NSAID

ACTIVE COMPARATOR

The Control group will be given nothing and only non-steroidal anti-inflammatory drugs on need

Drug: NSAID , NALUFIN , local anesthetic andTAP Block

Nalufin

ACTIVE COMPARATOR

group will be given IV nalufin

Drug: NSAID , NALUFIN , local anesthetic andTAP Block

local anesthetic group

ACTIVE COMPARATOR

the local anesthetic group will be given a S.C injection of local anesthetic in the wound

Drug: NSAID , NALUFIN , local anesthetic andTAP Block

TAP block

ACTIVE COMPARATOR

Total abdominal plain block group will be given a TAP block

Drug: NSAID , NALUFIN , local anesthetic andTAP Block

Interventions

NSAID , NALUFIN , local anesthetic andTAP BlockDRUG

The pain level of the cases is evaluated by means of the digital pain (numeric rating) scale from 0 to 10 in which 0 means "no pain" and 10 means "the worst pain" as well as the duration of pain relief and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present. In all groups non steroidal anti-inflammatory drugs will be given as a rescue analgesic and the total dose will be calculated and compared

NSAIDNalufinTAP blocklocal anesthetic group

Eligibility Criteria

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

You may qualify if:

  • Pregnant women aged 20-35 years
  • Gestational age between 37-40 weeks
  • Pregnant women undergoing elective cesarean section
  • Medically free
  • Singleton pregnancy

You may not qualify if:

  • Emergency cesarean section
  • Diabetic
  • Hypertensive
  • Severe anemia
  • Multiple pregnancy
  • Complication during section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Officials

  • ElSayed ElDesouky, Professor

    Al-Azhar University, Faculty of medicine for boys

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 11, 2022

Study Start

March 7, 2022

Primary Completion

March 20, 2022

Study Completion

April 1, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)