Efficacy of Caudal Block on Intra-operative Anal Sphincter Muscle Tone and Post-operative Analgesia During Anal Sphincter Sparing Procedures Under General Anaesthesia

NCT04651595 | Completed

• 1 other identifier: N-33-2019
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

upplementing general anaesthesia with caudal analgesia in sphincter sparing procedures might be useful as it will provide a satisfactory combination of sphincter muscle tone preservation, good intraoperative and postoperative analgesia along with a reduction in the consumption of opioids and anaesthetic drugs. To the best of our knowledge, this anaesthetic technique was not tested in sphincter sparing procedures before.

Conditions

Efficacy of Caudal Block on Intra-operative Anal Sphincter Muscle Tone

Outcome Measures

Primary Outcomes (1)

• The time to first request of rescue postoperative analgesic

  the time interval between the end of surgery and the first request to postoperative morphine

  in the first 24 hour

Secondary Outcomes (1)

• Digital Rectal Examination Scoring System (DRESS

  intraoperative

Study Arms (2)

Caudal

EXPERIMENTAL

Procedure: Caudal block

Control

ACTIVE COMPARATOR

Drug: Morphine

Interventions

Caudal block PROCEDURE

caudal block with low dose bupivicaine 0.25% to preserve tone

Caudal

Morphine DRUG

morphine to control pain and avoid using muscle relaxant

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- with complex anal fistula -

You may not qualify if:

• known hypersensitivity to amide type local anesthetics, contraindications to caudal block such as use of anticoagulant medication, local infection in the intervention site, increased intracranial pressure, severe aortic and / or mitral valve stenosis, and ischemic hypertrophic sub aortic stenosis, along with BMI (Body mass index) \> 35 kg/m2 , anatomical abnormalities or previous surgeries involving the sacrum.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr alainy medical school

Cairo, 12566, Egypt

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia, SICU and pain management

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

EG (1)