NCT02440399

Brief Summary

Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

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

May 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

May 7, 2015

Last Update Submit

May 8, 2017

Conditions

Post Cesarean Pain Management

Outcome Measures

Primary Outcomes (1)

  • The efficacy of pain management

    Pain sensation will be assessed using the NRS scale (numeric rating scale) for measurement of acute pain

    during 48 hours from surgery

Secondary Outcomes (6)

  • Patient satisfaction

    48 hours after surgery

  • The necessity of additional medications (rescue doses)

    During 48 hours after surgery

  • Adverse effect of the medications given in each protocol on the mother and neonates

    during 48 hours following surgery

  • To compare the amount of breastfeeding between 2 groups

    Following the week after surgery

  • Total amount of pain medications required in each study group

    during 48 hours following surgery and after 7 days

  • +1 more secondary outcomes

Study Arms (2)

Fix protocol - Oral treatment

EXPERIMENTAL

During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication): At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams). After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams. Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day. The total amount of paracetamol is limited to 4 gr per day.

Drug: Tramadol hydrochlorideDrug: ParacetamolDrug: DiclofenacDrug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)

Spinal morphine

EXPERIMENTAL

The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section

Drug: Morphine

Interventions

Tramadol hydrochlorideDRUG

Please see arm description

Fix protocol - Oral treatment
MorphineDRUG

Please see arm description

Spinal morphine
ParacetamolDRUG
Fix protocol - Oral treatment
DiclofenacDRUG
Fix protocol - Oral treatment
TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)DRUG
Fix protocol - Oral treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women that underwent cesarean section with sinal anesthesia

You may not qualify if:

  • Women who suffer from chronic pain
  • Women using chronic pain medications
  • Women with allergy to any drug used in the study
  • Women underwent general anesthesia during the surgery
  • Women who suffer from sleep apnea
  • Women who suffer from obesity (BMI\>40)
  • Women who suffer from severe nausea and vomiting after previous surgery
  • Women who received perioperative magnesium
  • Women who suffer from hypertension
  • Women who suffer from renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

Related Publications (1)

  • Yefet E, Nassar S, Carmeli J, Massalha M, Hasanein J, Zafran N, Rudin M, Nachum Z. Oral analgesia in fixed-time interval administration versus spinal morphine for post-Cesarean pain: a randomised controlled trial. Arch Gynecol Obstet. 2022 Apr;305(4):893-901. doi: 10.1007/s00404-021-06196-3. Epub 2021 Aug 31.

    PMID: 34463805DERIVED

MeSH Terms

Interventions

TramadolMorphineAcetaminophenDiclofenacOxycodone

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsCodeine

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD/PhD

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 12, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

IL(1)