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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03502642
Date of registration:	23/03/2018
Prospective Registration:	No
Primary sponsor:	Saint-Joseph University
Public title:	Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Scientific title:	Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial
Date of first enrolment:	May 29, 2017
Target sample size:	60
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03502642
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
Lebanon

Contacts

Name:	Nicole M Naccahe, M.D.
Address:
Telephone:
Email:
Affiliation:	Saint Joseph University- Lebanon

Name:	Hicham A Abou Zeid, M.D.
Address:
Telephone:
Email:
Affiliation:	Saint Joseph University- Lebanon

Name:	Samer H Hotayt, M.D.
Address:
Telephone:
Email:
Affiliation:	Saint Joseph University- Lebanon

Key inclusion & exclusion criteria

Inclusion Criteria:

- women.

- age between 18 and 50 years.

- gestational age 37 to 42 weeks.

- body mass index ranging from 18.0 to 30.0 kg/m2

- American Society of Anesthesiology (ASA) physical status I or II

- elective cesarean delivery with a Pfannenstiel incision

- spinal anesthesia.

Exclusion Criteria:

- history of chronic opioid use.

- Allergy to opioids and or local anesthetics.

- absolute or relative contraindication to neuraxial anesthesia.

- fever or any other sign of infection.

- Diabetes Mellitus under insulin therapy

- physical separation of patients from the neonate during the postoperative period.

Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Obstetric Pain

Intervention(s)

Drug: Ropivacaine (Ropivacaina Molteni®)

Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)

Drug: Normal saline

Drug: intrathecal morphine

Procedure: Spinal Anesthesia

Primary Outcome(s)

pain at rest [Time Frame: Hour 12]

pain at rest [Time Frame: Hour 48]

pain at rest [Time Frame: Hour 36]

pain at rest [Time Frame: Hour 2]

pain at rest [Time Frame: Hour 24]

pain at rest [Time Frame: Hour 6]

pain at rest [Time Frame: Hour 0, Hour 2, Hour 6, Hour 12, Hour 24, Hour 36 and Hour 48]

Secondary Outcome(s)

incidence of neurological alterations [Time Frame: Hour 12]

pain at mobilization [Time Frame: Hour 12]

incidence of pruritus [Time Frame: Hour 2]

pain at mobilization [Time Frame: Hour 24]

pain at mobilization [Time Frame: Hour 2]

sedation [Time Frame: Hour 0]

incidence of neurological alterations [Time Frame: Hour 2]

sedation [Time Frame: Hour 2]

incidence of postoperative nausea and vomiting [Time Frame: Hour 2]

incidence of postoperative nausea and vomiting [Time Frame: Hour 24]

pain at mobilization [Time Frame: Hour 36]

sedation [Time Frame: Hour 48]

incidence of neurological alterations [Time Frame: Hour 36]

incidence of neurological alterations [Time Frame: Hour 48]

incidence of postoperative nausea and vomiting [Time Frame: Hour 0]

incidence of pruritus [Time Frame: Hour 12]

return of gastrointestinal function [Time Frame: during the 48 hours postoperatively]

sedation [Time Frame: Hour 36]

incidence of urinary retention [Time Frame: during the 48 hours postoperatively]

sedation [Time Frame: Hour 6]

incidence of postoperative nausea and vomiting [Time Frame: Hour 6]

sedation [Time Frame: Hour 24]

incidence of neurological alterations [Time Frame: Hour 0]

incidence of neurological alterations [Time Frame: Hour 24]

incidence of neurological alterations [Time Frame: Hour 6]

incidence of postoperative nausea and vomiting [Time Frame: Hour 36]

incidence of postoperative nausea and vomiting [Time Frame: Hour 12]

incidence of postoperative nausea and vomiting [Time Frame: Hour 48]

incidence of pruritus [Time Frame: Hour 0]

incidence of pruritus [Time Frame: Hour 24]

pain at mobilization [Time Frame: Hour 0]

pain at mobilization [Time Frame: Hour 48]

incidence of pruritus [Time Frame: Hour 36]

incidence of pruritus [Time Frame: Hour 48]

pain at mobilization [Time Frame: Hour 6]

sedation [Time Frame: Hour 12]

incidence of pruritus [Time Frame: Hour 6]

Secondary ID(s)

CEHDF944

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

LEVENTON

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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