NCT03328390

Brief Summary

Regional anesthesia of the abdomen significantly reduce postoperative pain, spare the systemic opioids and decrease postoperative nausea and vomiting. Multiple regional techniques can be performed at the neuro-axis (epidural), the nerve root (paravertebral) and the peripheral nerve (transversus abdominis plane). Quadratus lumborum (QL) block is an addition into the league of truncal nerve block techniques that has been found to provide analgesia for abdominal surgeries. Several case reports have shown that local anesthetic injection around the quadratus lumborum muscle is effective in providing pain relief after various abdominal operations and in patients with chronic pain. The study hypothesis is that quadratus lumborum block in single shot may be more superior to transversus abdominus plane block as regard intra-operative and the post-operative analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jan 2016

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

Study Start

First participant enrolled

January 12, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

October 28, 2017

Last Update Submit

October 31, 2017

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • The total dose of morphine consumption

    milligram

    postoperative: in the first 24-hour

Secondary Outcomes (6)

  • the time to the first analgesic requirement

    postoperative: in the first 24-hour

  • pain intensity by visual analogue scale (VAS)

    postoperatively, at 0, 2, 4, 8, 16 and 24 hours

  • sedation score by Modified Ramsay sedation score

    postoperative, at 0, 2, 4, 8, 16 and 24 hours

  • postoperative nausea, vomiting

    postoperative in the first 24 hours

  • Mean blood pressure

    intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively.

  • +1 more secondary outcomes

Study Arms (2)

Quadratus lumborum block Group

EXPERIMENTAL

ultrasound guided

Other: Quadratus lumborum block

Transversus abdominis plane block Group

ACTIVE COMPARATOR

ultrasound guided

Other: Transversus abdominis plane block

Interventions

Quadratus lumborum blockOTHER

15 ml of 0.5% isobaric bupivacaine + 10 ml saline + 50 micro gram dexmedetomidine + epinephrine (1:100,000) for each side.

Also known as: Group Q
Quadratus lumborum block Group
Transversus abdominis plane blockOTHER

15 ml of 0.5% isobaric bupivacaine + 10 ml of saline + 50 micro gram dexmedetomidine + epinephrine (1:100,000) for each side.

Also known as: Group T
Transversus abdominis plane block Group

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for open abdominal cancer surgery.
  • American Society of Anesthesiologists physical status grade I and grade II.

You may not qualify if:

  • \. Patient refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies, …...) 3. Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5. Local skin infection and sepsis at site of the block. 6. Known intolerance to the study drugs. 7. Body Mass Index \> 40 Kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncolgy Center, Mansoura University,

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sensitivity Training Groups

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor of anesthesia and surgical intensive care

Study Record Dates

First Submitted

October 28, 2017

First Posted

November 1, 2017

Study Start

January 12, 2016

Primary Completion

July 15, 2017

Study Completion

July 15, 2017

Last Updated

November 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

after publication

Shared Documents
SAP, CSR
Time Frame
no limit

Locations

EG(1)