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

• Sponsor: Theodor Bilharz Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03225313
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.7
• Patients Per Site Per Month: 16.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ultrasound Guided Rectus Sheath Block; Pain, Postoperative	Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4; Drug: Normal Saline Flush, 0.9% Injectable Solution_#5; Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4	N/A

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.

1. 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.

2. 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.

3. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Ultra Sound Guided Rectus Sheath Block or Field Block for Midline Hernia Repair: A Comparative Study
• Actual Study Start Date: Aug 10, 2017
• Actual Primary Completion Date: Dec 30, 2017
• Actual Study Completion Date: Dec 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control group normal saline will be injected in the rectus sheath	Drug: Normal Saline Flush, 0.9% Injectable Solution_#5; injected into rectus sheath using ultrasound & locally surrounding the hernia
Active Comparator: Rectus block group bupivicaine will be injected in the rectus sheath	Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4; ultra sound guided injection into the rectus sheath
Experimental: Field block group bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia	Drug: Bupivacaine Hydrochloride 0.5% Injection Solution_#4; locally surrounding the hernia

Outcome Measures

Primary Outcome Measures

1. Immediate Postoperative Pain [evaluation of postoperative pain in patients immediately after the 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.

2. Postoperative Pain at 2 Hours After Procedure. [evaluation of postoperative pain in patients 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.

3. Postoperative Pain at 6 Hours After Procedure. [Evaluation of postoperative pain in patients 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

1. 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 cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.

2. Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique. [1 hour after the start of the surgery using ELISA technique.]

   Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.

3. Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. [1 hour after the start of the surgery]

   Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.

4. Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique. [30 minutes before the start of the surgery]

   Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery

5. Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique. [30 minutes before the start of the surgery]

   Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

6. Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique. [30 minutes before the start of the surgery.]

   Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Theodor Bilharz Research Institute	Giza		Egypt

Sponsors and Collaborators

• Theodor Bilharz Research Institute

Investigators

• Principal Investigator: mohammed ma hussein, lecturer, Theodor Bilharz Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 20, 2017

More Information

Publications

None provided.

• Responsible Party: Mohamed Hussein, Lecturer of Anesthesia and Surgical intensive care, Theodor Bilharz Research Institute
• ClinicalTrials.gov Identifier: NCT03225313
• Other Study ID Numbers: 722014
• First Posted: Jul 21, 2017
• Last Update Posted: Mar 9, 2021
• Last Verified: Mar 1, 2021

• 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
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	ASA I & II patients. 25 patient in each group.
Pre-assignment Detail	Prospective randomized double blinded controlled clinical trial was done with a total number of 75 patients divided into 3 groups .

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Period Title: Overall Study
STARTED	25	25	25
COMPLETED	25	25	25
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group	Total
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Total of all reporting groups
Overall Participants	25	25	25	75
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	25 100%	75 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.80 (9.941)	42.20 (10.464)	44.08 (8.544)	43.76 (9.606)
Sex: Female, Male (Count of Participants)
Female	22 88%	17 68%	19 76%	58 77.3%
Male	3 12%	8 32%	6 24%	17 22.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Egypt	25 100%	25 100%	25 100%	75 100%
Body Weight in Kilograms (Kilogram) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilogram]	82.7 (13.9)	83.7 (11.8)	82 (10.6)	82.87 (12.115)

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [score on a scale]	7.36 (2.691)	1.04 (1.837)	6.56 (3.029)

2. Primary Outcome

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.

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [score on a scale]	6.04 (1.645)	1.20 (1.826)	5.12 (1.833)

3. Primary Outcome

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.

Outcome Measure Data

Analysis Population 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.

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [score on a scale]	5.28 (2.011)	2.64 (1.497)	5.16 (2.304)

4. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.

Arm/Group Title	Control Group	Rectus Block Group	Local Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [nmol/ liter]	307.84 (220.569)	214.00 (148.198)	286.92 (225.404)

5. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [ng/ml]	2.508 (1.2530)	2.556 (1.4030)	2.704 (1.1264)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [ng/ml]	12.088 (4.6656)	17.380 (9.0959)	15.920 (7.3389)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [nmol/ liter]	159.02 (119.455)	327.05 (215.569)	170.52 (91.421)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [ng/ml]	1.42 (0.774)	3.96 (2.262)	2.00 (1.416)

9. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Measurement of serum noradreline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

Arm/Group Title	Control Group	Ultra- Sound Rectus Sheath Block Group	Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally	bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Measure Participants	25	25	25
Mean (Standard Deviation) [ng/ml]	9.960 (4.2880)	20.880 (10.5235)	12.932 (6.4223)

Adverse Events

Time Frame	24 hours after giving the local anaesthesia
Adverse Event Reporting Description	Cardiac arrhythmia.
Arm/Group Title	Control Group		Ultra- Sound Rectus Sheath Block Group		Local Infilteration Group
Arm/Group Description	normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath & locally		bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath		bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
All Cause Mortality
	Control Group		Ultra- Sound Rectus Sheath Block Group		Local Infilteration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Control Group		Ultra- Sound Rectus Sheath Block Group		Local Infilteration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Ultra- Sound Rectus Sheath Block Group		Local Infilteration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.