NCT02566096

Brief Summary

This study aims to compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 15, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

September 30, 2015

Last Update Submit

July 14, 2016

Conditions

Abdominal Cancer

Keywords

major abdominal cancer

Outcome Measures

Primary Outcomes (1)

  • The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale

    The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale will be assessed postoperatively at baseline, 2, 4, 6, 8, 12, 18, and 24 hours.

    first 24 hours postoperatively

Secondary Outcomes (2)

  • the level of sedation by using sedation score

    24 hours postoperatively

  • first request for analgesia in minutes will be observed

    firsr 24 hours

Study Arms (2)

TAP with bupivicaine

PLACEBO COMPARATOR

30 patients receive ultrasound guided transversus abdominis-plane block (TAP) with local anesthetic 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Drug: transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine

TAP with bupivicaine with morphine

ACTIVE COMPARATOR

30 patients receive ultrasound guided transversus abdominis-plane block (TAP) with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Drug: transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine

Interventions

transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphineDRUG

compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine with morphine in patients undergoing major abdominal cancer surgery.

TAP with bupivicaineTAP with bupivicaine with morphine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II cancer patients with age range (18-60) years,
  • weight (50- 85) kg

You may not qualify if:

  • with patients with known drug allergy to study drugs
  • with significant cardiac, respiratory, renal or hepatic disease
  • with coagulation disorders
  • those with psychiatric illnesses that would interfere with perception and assessment of pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Instuite

Asyut, 171516, Egypt

Location

Related Publications (1)

  • El Sherif FA, Mohamed SA, Kamal SM. The effect of morphine added to bupivacaine in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia following lower abdominal cancer surgery, a randomized controlled study. J Clin Anesth. 2017 Jun;39:4-9. doi: 10.1016/j.jclinane.2017.03.009. Epub 2017 Mar 10.

    PMID: 28494906DERIVED

MeSH Terms

Interventions

Anesthetics, LocalBupivacaineMorphine

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

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

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 15, 2016

Record last verified: 2016-03

Locations

EG(1)