Trial no.:	PACTR201611001880888	Date of Approval:	20/11/2016
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Ultrasound guided bilateral rectus sheath block for upper abdominal surgery using bupivacaine versus bupivacaine morphine.

Official scientific title

US guided rectus sheath with morphine

Brief summary describing the background and objectives of the trial

Adequate post-operative analgesia is one of the key elements in all Enhanced Recovery Programs which consist of a series of protocolised multimodal interventions aimed at reducing complications, thereby expediting recovery(1). This reduces the stress response, improves patient wellbeing and allows early mobilization. Early mobilization itself is important to reduce secondary complications such as chest infection and deep vein thrombosis (Gustafsson et al ; 2013 ). Rectus sheath block (RSB) is a regional anesthetic technique in which the ventral rami of the seventh to twelfth intercostal nerves, which supply the rectus abdominis muscle and overlying skin, are blocked . This sensory blockade is achieved by injecting local anesthetic into the potential space between the rectus muscle and the posterior rectus sheath as a single bolus which has a maximum duration of 12 hours.(Webster ;2010). This provides midline analgesia, with additional doses of systemic opiate required for visceral analgesia (12 to 36 hours duration). Although this regional block was first described at the turn of the last century (Webster ;2010) and (Sandeman and Dilley; 2008). It was used infrequently until the recent availability of long-acting local anesthetic agents and small portable ultrasound machines which enabled us to accurately place the local anesthetic at the target ( Marhofer et al; 2005). These developments have resulted in renewed interest in RSB for the management of post-operative pain following midline abdominal incisions (Willschke ; 2006) and ( Dolan et al ; 2007) . We hypotheses that when performing bilateral rectus sheath block for pain relieve in upper abdominal surgeries, the combination of bupivacaine morphine is more effective than bupivacaine alone.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Anaesthesia,Surgery,upper abdominal surgeries like spleen, calcular obstructive jaundice, liver masses, hiatus hernia,

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

15/06/2015

Actual trial start date

20/06/2015

Anticipated date of last follow up

02/07/2016

Actual Last follow-up date

31/07/2016

Anticipated target sample size (number of participants)

58

Actual target sample size (number of participants)

60

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register
R132	medical local ethical committee /Mansoura faculty of medicicne

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study	Randomised	Simple randomisation using by using procedures such as coin-tossing or dice-rolling	Simple randomisation using by using procedures such as coin-tossing or dice-rolling	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	us guided rectus sheath with bupivacaine	Bupivacaine 0.25 % with epinephrine 1/200000 ( 5ug/ml ) plus Morphine 1 mg given on each side with a total volume of 15 ml on each side	single injection	¿ Group B ( Bupivacaine ) whom will receive Bupivacaine 0.25 % with epinephrine 1/200000 ( 5ug/ml ) in a volume of 15 ml on each side .	30	Active-Treatment of Control Group
Experimental Group	us guided rectus sheath with bupivacaine morphine	Bupivacaine 0.25 % with epinephrine 1/200000 ( 5ug/ml ) plus Morphine 1 mg given on each side with a total volume of 15 ml on each side .	single injection	¿ Group BM ( bupivacaine morphine) whom will receive Bupivacaine 0.25 % with epinephrine 1/200000 ( 5ug/ml ) plus Morphine 1 mg given on each side with a total volume of 15 ml on each side .	30

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Patients aged between 25 and 65 years old ASA class I and II who will undergo upper abdominal surgeries like spleen, calcular obstructive jaundice, liver masses, hiatus hernia, with midline abdominal incision will be included in this study.	patient refusal, local or systemic infection, coagulopathy , Inability to see the posterior rectus sheath when using ultrasound and also allergy to local anesthetics		25 Year(s)	65 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

13/06/2015

Local Ethical committee Mansoura faculty of medicine

Ethics Committee Address
Street address	City	Postal code	Country
Elgmhoria street	Elmansourah	35516	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Anatomy of the rectus in adults under ultrasound	before the procedure
Primary Outcome	the analgesic efficacy and possible side effects of bilateral sonographic-guided rectus sheath.	Also pain score will be assessed for all patients immediately after surgery, then 2, 4 6, 12, 18, 24 hours after surgery using visual analogue scale and numerical pain score
Secondary Outcome	Moreover the time of 1st opioid requirement and total daily opioid consumption will be recorded.	all over the 24 hours
Secondary Outcome	possible side effects will be recorded including nausea, vomiting, hypotension and constipation.	postoperatively

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Mansourah Gastroenterology surgery center (GESC) , Mansourah university .	Elgmhoria street	ElMansourah	35516	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Mansourah gastroenterology center	Elgmhoria street	ElMansourah	35516	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Mansourah gastroenterology center	Elgmhoria street	ElMansourah	35516	Egypt	Hospital

COLLABORATORS
Name	Street address	City	Postal code	Country
alaa adel elmaadawy	Elgmhoria street	ElMansourah	35516	Egypt
Emad A. Elhefnawy	Elgmhoria street	ElMansourah	35516	Egypt
Hazem elsayed Moaawad				Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	alaa elmaadawy	a_maadawy@hotmail.com	00201153304999	Elgmhoria street
City	Postal code	Country	Position/Affiliation
elmansourah	35516	Egypt	lecturer in anesthesia , pain managment
Role	Name	Email	Phone	Street address
Public Enquiries	Emad Elhefnawy	emadhefnawy@yahoo.com	00201005686033	Elgmhoria street
City	Postal code	Country	Position/Affiliation
elmansourah	35516	Egypt	lecturer in anesthesia , pain managment
Role	Name	Email	Phone	Street address
Scientific Enquiries	alaa elmaadawy	a_maadawy@hotmail.com	00201153304999	Elgmhoria street
City	Postal code	Country	Position/Affiliation
elmansourah	35516	Egypt	lecturer in anesthesia , pain managment

REPORTING
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Result URL Hyperlinks

Changes to trial information

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