NCT03516786

Brief Summary

The aim of this prospective study is to evaluate the recovery after cesarean section in patients who will receive Quadratus Lumborum Block (QLB) as a part of multimodal analgesia using Postoperative quality of recovery scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

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 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

March 19, 2018

Last Update Submit

September 15, 2020

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • change from baseline postoperative quality of recovery score

    Domains of postoperative recovery score are : 1. The physiologic domain . 2. The nociceptive domain 3. The emotive domain . 4. Activities of daily living 5. Cognitive domain 6. Over all patients perspective domain

    72 hours

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women at term
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Twenty five parturients, with American Society of Anesthesiologists (ASA) physical status II, with normal singleton pregnancy, at 37 weeks gestation or more, admitted to Corniche Hospital for elective caesarean section under spinal anesthesia

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status II, normal singleton pregnancy, 37 weeks gestation or more Scheduled for elective cesarean section

You may not qualify if:

  • Patients refusing spinal
  • Patients with BMI \>35 kg/m2).
  • Expected difficult surgery (\> 3 previous sections, abnormal placentation, prolonged surgery more than 2 hours from skin to end) and Estimated Blood Loss more than 1500).
  • Expected difficult spinal anesthesia.
  • Abnormal coagulation and other contraindications for spinal anesthesia and/or QLB
  • Patient with chronic pain.
  • Patient treated from psychosis.
  • Patients with communication, language barriers .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corniche Hospital

Abu Dhabi, 3788, United Arab Emirates

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Waleed Riad, MD

    Corniche Hospital

    PRINCIPAL INVESTIGATOR

  • Amr Maher, MD

    Corncihe hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

May 4, 2018

Study Start

April 1, 2018

Primary Completion

September 15, 2019

Study Completion

October 1, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

AE(1)