NCT02380898

Brief Summary

Our study is planned to investigate if pre-emptive Ketorolac would decrease the incidence of intraoperative shoulder tip pain and improve discomfort during Caesarean section.

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 phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

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

March 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 14, 2017

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

March 1, 2015

Last Update Submit

September 12, 2017

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • Intraoperative shoulder tip pain

    intraoperative

Secondary Outcomes (1)

  • pain score VAS

    intraoperative

Study Arms (2)

Ketorolac

EXPERIMENTAL
Drug: Ketorolac

Normal saline 0.9%

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

KetorolacDRUG

30 mg ketorolac immediately before induction of anesthesia

Ketorolac
Normal salineDRUG

4 mL normal saline 0.9% immediately before induction of anesthesia

Normal saline 0.9%

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • nulligravida healthy women who delivered single term baby, with American Society of Anesthesiologists physical status 1 or 2

You may not qualify if:

  • previous caesarean section; pre-eclampsia; gestational diabetes; trauma; fractures or chronic pain in shoulder joints, forearms, upper limbs; cardiovascular or biliary system disorders; women undergoing emergency caesarean; previous history of abdominal surgery; conditions preventing spinal block, including local infection; coagulopathies; haemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, 11111, Egypt

Location

Related Publications (1)

  • Abbas MS, Askar OA, Abdel Aleem AA. Pre-emptive ketorolac for prevention of intraoperative shoulder pain in patients undergoing cesarean section: A double blind randomized clinical trial. Asian J Anesthesiol. 2017 Sep;55(3):68-72. doi: 10.1016/j.aja.2017.07.002. Epub 2017 Sep 20.

    PMID: 28993164DERIVED

MeSH Terms

Interventions

KetorolacSaline Solution

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and ICU, Assiut University,Assiut, Egypt

Study Record Dates

First Submitted

March 1, 2015

First Posted

March 5, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 14, 2017

Record last verified: 2015-12

Locations

EG(1)