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

Pain, Postoperative Clinical Trial

Official title:

Ultra Sound Guided Rectus Sheath Block or Field Block for Midline Hernia Repair: A Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225313
• Other study ID #: 722014
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: December 30, 2017

Study information

• Verified date: March 2021
• Source: Theodor Bilharz Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Ultrasound Guided Rectus Sheath Block

Intervention

Drug:
• Bupivacaine Hydrochloride 0.5% Injection Solution_#4
ultra sound guided injection into the rectus sheath
• Normal Saline Flush, 0.9% Injectable Solution_#5
injected into rectus sheath using ultrasound & locally surrounding the hernia
• Bupivacaine Hydrochloride 0.5% Injection Solution_#4
locally surrounding the hernia

Locations

Country	Name	City	State
Egypt	Theodor Bilharz Research Institute	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	evaluation of postoperative pain in patients immediately after the procedure.
Primary	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.	evaluation of postoperative pain in patients at 2 hours after procedure.
Primary	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.	Evaluation of postoperative pain in patients at 6 hours after procedure.
Secondary	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.
Secondary	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.	1 hour after the start of the surgery using ELISA technique.
Secondary	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.	1 hour after the start of the surgery
Secondary	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	30 minutes before the start of the surgery
Secondary	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.	30 minutes before the start of the surgery
Secondary	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.	30 minutes before the start of the surgery.