Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery (ITVSEpidural)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02988700
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, Assiut University

Brief Summary:

Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.

Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.

- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5% Drug: caudal plain bupivacaine 2.5mg/kg 0.25% Phase 2 Phase 3

Detailed Description:

The historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia.

-Pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (paracetamol).

Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.

Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.

- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery
Study Start Date : November 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Spinal group

Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.

be given by .

Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%
The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.
Other Name: Marcain

Active Comparator: Caudal group
caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2‑3mm deeper.
Drug: caudal plain bupivacaine 2.5mg/kg 0.25%
The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2‑3mm deeper.
Other Name: Bucain




Primary Outcome Measures :
  1. FLACC Score [ Time Frame: 24 hours ]
    FLACC scores will be recorded.


Secondary Outcome Measures :
  1. Total consumption of rescue analgesics [ Time Frame: 24 hours ]
    The total consumption of postoperative rescue analgesics will be recorded.

  2. Postoperative Agitation [ Time Frame: 60 min. ]
    Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.

  3. Adverse effects [ Time Frame: 24 hours ]
    Any adverse effect will be treated and recorded.

  4. Residual motor paralysis [ Time Frame: 6 hours ]
    By the Modified Bromage scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 2-12 years.
  • Weight: 15-40 kg.
  • Sex: both males and females.
  • ASA physical status: 1-II.
  • Operation: surgery below umbilicus.

Exclusion Criteria:

  • Allergic reaction to local anesthetics (LAs).
  • Local or systemic infection (risk of meningitis).
  • Coagulopathy.
  • Intracranial hypertension.
  • Hydrocephalus.
  • Intracranial hemorrhage.
  • Parental refusal.
  • Hypovolemia.
  • Spinal deformities, such as spina bifida or myelomeningocele.
  • Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988700


Contacts
Layout table for location contacts
Contact: Hala S Abdel-Ghaffar, MD 01003812011 ext +2088 hallasaad@yahoo.com
Contact: Peter S Attallah, MBBCH 01004949314 ext +2088 mr_pepo66@yahoo.com

Locations
Layout table for location information
Egypt
Hala Saad Abdel-Ghaffar Recruiting
Assiut, Assiut Governorate, Egypt, 715715
Contact: Hala S Abdel-Ghaffar, MD    01003812011 ext +2 088    hallasaad@yahoo.com   
Contact: Peter S Attallah, MBBCH    01004949314 ext +2 088    mr_pepo66@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Principal Investigator: Hala S Abdel-Ghaffar, MD Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

Layout table for additonal information
Responsible Party: Hala Saad Abdel-Ghaffar, Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt., Assiut University
ClinicalTrials.gov Identifier: NCT02988700     History of Changes
Other Study ID Numbers: IRB00008718/36800
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents