NCT03264430

Brief Summary

Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal bupivavaine in selective saddle block for perianal surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

May 29, 2017

Last Update Submit

January 13, 2018

Conditions

Perianal FistulaHemorrhoids

Keywords

Perianal fistulaHemorrhoids

Outcome Measures

Primary Outcomes (1)

  • - Duration of saddle block

    (time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS \>4)

    24 hours post-operative

Secondary Outcomes (1)

  • Evaluation of the need of supplemental analgesia

    24 hours post-operative

Study Arms (2)

The ketamine group

ACTIVE COMPARATOR

The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected

Drug: KetamineDrug: bupivacaine

The control group

PLACEBO COMPARATOR

group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.

Drug: bupivacaine

Interventions

KetamineDRUG

an antagonist of the NMDA receptor

Also known as: ketalar
The ketamine group
bupivacaineDRUG

local anaesthetic

Also known as: marcaine 0.5 %
The control groupThe ketamine group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will be included in the study only if they meet all of the following criteria:
  • Patients scheduled for perianal surgeries.
  • Age 18-55 years.
  • ASA physical status I-II.

You may not qualify if:

  • Subjects will be excluded from the study for any of the following reasons:
  • Patient refusal
  • Any contraindication of regional anaesthesia
  • Failed Technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhoids

Interventions

KetamineBupivacaine

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 29, 2017

First Posted

August 29, 2017

Study Start

January 1, 2017

Primary Completion

October 31, 2018

Study Completion

December 31, 2018

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share