NCT03394001

Brief Summary

The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

January 3, 2018

Last Update Submit

January 5, 2018

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Rescue analgesia time

    Time for first analgesia requirement

    First 24 hours postoperatively

Secondary Outcomes (2)

  • Patient's pain score

    First 24 hours postoperatively

  • The total analgesic consumption

    First 24 hours postoperatively

Study Arms (2)

Lidocaine Hydrochloride

ACTIVE COMPARATOR

Wound infiltration with Lidocaine

Procedure: Wound infiltrationDrug: Lidocaine Hydrochloride

Ketorolac tromethamine

ACTIVE COMPARATOR

Wound infiltration with Ketorolac

Procedure: Wound infiltrationDrug: Ketorolac tromethamine

Interventions

Wound infiltrationPROCEDURE

Before skin closure,the subcutaneous tissue and skin all around the wound will be infiltrated by 20 mL of the drug then closure of the skin will be done.

Ketorolac tromethamineLidocaine Hydrochloride
Lidocaine HydrochlorideDRUG

20 ml of 1% Lidocaine solution

Also known as: Lidocaine Hydrochloride; Lidocaine HCL 50mg/5 ml
Lidocaine Hydrochloride
Ketorolac tromethamineDRUG

20 mL of saline with 30 mg ketorolac

Also known as: Adolor; Ketorolac tromethamine 30mg/2ml
Ketorolac tromethamine

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I and II
  • Planned for elective TAH with a Pfannenstiel incision

You may not qualify if:

  • Patients with the following criteria will be excluded from the study;
  • ASA physical status more than II
  • Body mass index (BMI)\>35 kg/m2
  • Previous abdominal surgeries
  • Malignancy
  • Individuals with chronic pain
  • A history of severe systemic disease
  • A pre-existing neurological or psychiatric illness
  • Known to be addict on alcohol or drugs
  • Known allergy to the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

LidocaineKetorolac Tromethamine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 9, 2018

Study Start

January 1, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

EG(1)