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Comparison Between Ultra Sound Guided Rectus Sheath Block and Field Block for Midline Hernia Repair

Primary Purpose

Ultrasound Guided Rectus Sheath Block, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride 0.5% Injection Solution_#4
Normal Saline Flush, 0.9% Injectable Solution_#5
Bupivacaine Hydrochloride 0.5% Injection Solution_#4
Sponsored by
Theodor Bilharz Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ultrasound Guided Rectus Sheath Block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Elective midline hernia repair surgery.
  2. Age: adult patients between 18 - 60 years old.
  3. Gender: Both male and female.
  4. ASA Class: I & II.

Exclusion Criteria:

  1. Refusal of patient.
  2. Pregnancy and lactation.
  3. Fever or sepsis.
  4. Patients ASA III or IV.
  5. Addicts and drug abusers.
  6. Patients taking corticosteroids or any cardio - active drugs.
  7. Local infection at site of the injection.
  8. Allergy to any of the study medications.

Sites / Locations

  • Theodor Bilharz Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

control group

Rectus block group

Field block group

Arm Description

normal saline will be injected in the rectus sheath

bupivicaine will be injected in the rectus sheath

bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia

Outcomes

Primary Outcome Measures

Immediate Postoperative Pain
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.
Postoperative Pain at 2 Hours After Procedure.
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.
Postoperative Pain at 6 Hours After Procedure.
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

Secondary Outcome Measures

Change in the Level of Serum Cortisol.
Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.
Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique.
Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.
Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.
Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.
Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery
Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.
Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.
Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

Full Information

First Posted
June 10, 2017
Last Updated
March 6, 2021
Sponsor
Theodor Bilharz Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03225313
Brief Title
Comparison Between Ultra Sound Guided Rectus Sheath Block and Field Block for Midline Hernia Repair
Official Title
Ultra Sound Guided Rectus Sheath Block or Field Block for Midline Hernia Repair: A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Theodor Bilharz Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Randomized double blinded controlled clinical trial will be done with a total number of 75 patients will be divided into 3 groups. To compare between Ultra-sound guided rectus sheath block VS Field block infiltration in providing a good analgesia for patients undergoing midline hernia repair to detect which one is superior.
Detailed Description
75 patients undergoing midline hernia repair under general anesthesia will be recruited and will be randomly allocated using closed envelope technique as follows: Control group, Local infilteration (Field block infilteration) group, Ultra sound Guided Rectus sheath block group. General anesthesia will be standardized for all patients with : 2 µg kg-1 fentanyl and 2 mg kg-1 propofol. Neuromuscular blockade will be achieved with 0.5 mg kg-1 atracurium followed by tracheal intubation. Muscle relaxation will be maintained by 0.1mg / kg / 30 minute of Atracrurium. Anesthesia will be maintained by sevoflurane. Mechanical ventilation will be adjusted with fresh gas flow oxygen in air 30-50% at a rate of 1 L min-1to maintain end-tidal carbon dioxide of 35-40 mm Hg and Spo2 greater than 94%. BIS values will be maintained between 40 and 60. All surgical procedures will be done in the range between 10 am and 1 pm and by the same surgical team. Control group : will receive field block using 0.3 ml/kg of normal saline at site of the hernia plus ultra- sound guided rectus sheath injection using 0.3 ml / kg of normal saline. Field block group: will receive 0.3 ml / kg of 0.5% bupivicaine subcutaneously surrounding the site of the hernia following the induction of anesthesia and ultra-sound guided rectus sheath block with 0.3 ml / kg of normal saline. Ultrasound guided rectus sheath block : Under sterile conditions a 21/22 G , 50- 100 milli meter length echogenic needle guided by the ultrasound into rectus sheath at the level of the umbilicus , using an - in plane technique. After -ve aspiration 0.3 ml/ kg of 0.5 % bupivicaine will be deposited on each side and the spread of local anesthesia will be observed by ultrasound plus 0.3 ml/kg of normal saline subcutaneously at the site of the hernia. All solutions used will be prepared by a colleague who will not participate into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound Guided Rectus Sheath Block, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
normal saline will be injected in the rectus sheath
Arm Title
Rectus block group
Arm Type
Active Comparator
Arm Description
bupivicaine will be injected in the rectus sheath
Arm Title
Field block group
Arm Type
Experimental
Arm Description
bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride 0.5% Injection Solution_#4
Intervention Description
ultra sound guided injection into the rectus sheath
Intervention Type
Drug
Intervention Name(s)
Normal Saline Flush, 0.9% Injectable Solution_#5
Intervention Description
injected into rectus sheath using ultrasound & locally surrounding the hernia
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride 0.5% Injection Solution_#4
Intervention Description
locally surrounding the hernia
Primary Outcome Measure Information:
Title
Immediate Postoperative Pain
Description
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.
Time Frame
evaluation of postoperative pain in patients immediately after the procedure.
Title
Postoperative Pain at 2 Hours After Procedure.
Description
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.
Time Frame
evaluation of postoperative pain in patients at 2 hours after procedure.
Title
Postoperative Pain at 6 Hours After Procedure.
Description
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.
Time Frame
Evaluation of postoperative pain in patients at 6 hours after procedure.
Secondary Outcome Measure Information:
Title
Change in the Level of Serum Cortisol.
Description
Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.
Time Frame
Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.
Title
Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique.
Description
Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.
Time Frame
1 hour after the start of the surgery using ELISA technique.
Title
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.
Description
Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.
Time Frame
1 hour after the start of the surgery
Title
Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.
Description
Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery
Time Frame
30 minutes before the start of the surgery
Title
Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.
Description
Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.
Time Frame
30 minutes before the start of the surgery
Title
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.
Description
Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.
Time Frame
30 minutes before the start of the surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elective midline hernia repair surgery. Age: adult patients between 18 - 60 years old. Gender: Both male and female. ASA Class: I & II. Exclusion Criteria: Refusal of patient. Pregnancy and lactation. Fever or sepsis. Patients ASA III or IV. Addicts and drug abusers. Patients taking corticosteroids or any cardio - active drugs. Local infection at site of the injection. Allergy to any of the study medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammed ma hussein, lecturer
Organizational Affiliation
Theodor Bilharz Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Theodor Bilharz Research Institute
City
Giza
Country
Egypt

12. IPD Sharing Statement

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Comparison Between Ultra Sound Guided Rectus Sheath Block and Field Block for Midline Hernia Repair

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