Trial no.:	PACTR202607576587184	Date of Registration:	30/07/2026
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Analgesic efficacy of ultrasound guilded external oblique and rectus abdominis (EXORA) block for liver resection surgery: A randomized controlled trial

Official scientific title

Analgesic efficacy of ultrasound guilded external oblique and rectus abdominis (EXORA) block for liver resection surgery: A randomized controlled trial

Brief summary describing the background and objectives of the trial

Hepatectomy is one of the important methods in the treatment of primary liver cancer and the most effective way to achieve long-term survival from liver cancer. Postoperative pain is one of the most common symptoms of patients after liver resection In an attempt to achieve abdominal analgesia by blockade of the thoracoabdominal nerves, there are several types of field blocks. The transversus abdominal plane block (TAP) and its variations can provide analgesia in the abdominal region. On the other hand, the fact that the upper abdomen is outside the scope of the lateral and anterior fields in this type of block has led researchers to different approaches. We present the results of the external oblique and rectus abdominis plane (EXORA) block, a new block application that can be used for this purpose

Type of trial

RCT

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

Disease(s) or condition(s) being studied

Anaesthesia,Digestive System

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

Purpose of the trial

detection of suitable route of analgesia postresection

Anticipated trial start date

14/01/2026

Actual trial start date

01/02/2026

Anticipated date of last follow up

30/07/2026

Actual Last follow-up date

30/07/2026

Anticipated target sample size (number of participants)

70

Actual target sample size (number of participants)

70

Recruitment status

Active, not recruiting

Publication URL

academic citation

Secondary Ids	Issuing authority/Trial register

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
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table from a statistics book	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	will receive the same standard analgesia plan with block with saline .	General anesthesia induction will be performed with IV propofol 2–3 mg/kg, fentanyl 1-2 μg/kg, and rocuronium bromide 0.6 mg/kg, then endotracheal intubation with an appropriate size	24hour post operation	anesthesia nociception index (ANI) value if less than 50 beside intraoperative hemodynamics (heart rate and blood pressure) if increased more than 20% of baseline, 50 mic fentanyl will be given. Hypotension considered if BP decreased 20% of baseline (30mg ephedrine will be injected). Bradycardia considered if patient heartbeat <60 beat/minute (1mg atropine will be injected).	35	Placebo
Experimental Group	EXORA	0.25% concentration) (10 mL of bupivacaine 0.5% and 10 mL of normal saline ) in each side, while those of group II will be injected with 20 mL of normal saline only in each side.	24hour postoperative	After induction of general anesthesia and before the beginning of surgery, a bilateral EXORA block will be performed After skin sterilization, (linear probe Sonosite-Nano max ultrasound system, Bothell-USA) will be placed vertically in the cranio-caudal direction in the sagittal position on the parasternal line lateral to the xiphoid process of the sternum. The probe will be advanced caudally, and after the detection of the 6th costal cartilage, the 8th costal cartilage will be counted and detected. This area will define the rectus abdominis muscle and underlying costal cartilage in the field of view of the transversely positioned probe. Needle will be inserted in a medial to lateral direction	35

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
• Patients undergoing elective liver resection surgery. • The age between of 21 and 64years with a body mass index (BMI) of 18-35 kg/m2. • American Society of Anesthesiologists (ASA) class I-III. • Gender: both sexes	• Patient refusal. • Uncontrolled diabetes mellitus. • Mental retardation. • Use of antidepressants. • coagulopathy.. • Allergy to local anesthetics. • Infection at the site of injection. • Addiction to opioids, alcohol, or a history of any other substance abuse.	Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	21 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

02/06/2025

menoufia university faculty of medicine

Ethics Committee Address
Street address	City	Postal code	Country
shibien el kom	shibien el kom	32631	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	To evaluate total opoid consumption between two groups intraoperative and postoperative.	24 hour postoperative
Secondary Outcome	1. Time for the first request for rescue analgesia (when VAS is 4 or more). 2. To evaluate Pain control by EXORA compared to control group intraoperative by ANI value and postoperative by Visual analogue score (VAS) in each group. 3. Intraoperative and postoperative hemodynamic variables (HR & mean ABP). 4. Incidence of postoperative complication (nausea, vomiting, pulmonary complication).	24 hour postoperative

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
national liver institute	shibien el kom	shibien el kom	32631	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
national liver institute	shibien el kom	shibien el kom	32631	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	ghada mahmoud	quesna	quesna	32632	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	ghada mahmoud	dr.ghadamahmoud84@gmail.com	0201024595554	quesna
City	Postal code	Country	Position/Affiliation
quesna	32632	Turkey	lecture of anasthesia
Role	Name	Email	Phone	Street address
Principal Investigator	hala abozied	Halaabozied04@gmail.com	01023019062	shebien elkom
City	Postal code	Country	Position/Affiliation
shebien elkom	32511	Egypt	residence
Role	Name	Email	Phone	Street address
Scientific Enquiries	fatma mahmoud	dr.ghadamahmoud84@gmail.com	01014811263	cairo
City	Postal code	Country	Position/Affiliation
cairo	11511	Egypt	professor
Role	Name	Email	Phone	Street address
Public Enquiries	dodi mahmoud	dr.ghadamahmoud84@gmail.com	01024595554	quesna
City	Postal code	Country	Position/Affiliation
el menofia	32632	Egypt	assisted rofessore

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	in patient departement pt will undergoing liver resection Baseline Data: Patient demographics (age, sex) and clinical characteristics (Body Mass Index, ASA classification). Primary Outcome Data: Quantified total intraoperative opioid consumption and total postoperative nalbuphine consumption (measured in milligrams/micrograms) recorded over the first 24 hours post-surgery. Secondary Outcome Data: Analgesia Nociception Index (ANI) values recorded at baseline, post-induction, 10 minutes post-block, at skin incision, and every 15 minutes intraoperatively. Postoperative Visual Analogue Scale (VAS) pain scores assessed at arrival to the ward, and at 2, 6, 12, 18, and 24 hours postoperatively. Exact time elapsed (in minutes) from block administration to the patient's first request for rescue analgesia. Hemodynamic variables: Serial measurements of Heart Rate (HR) and Mean Arterial Pressure (MAP) across all intraoperative and postoperative tracking intervals Patients undergoing elective liver resection surgery. Qualified academic researchers, clinical investigators, or biostatisticians with a verified institutional affiliation. What documentation is required? A methodologically sound, written research proposal detailing the specific scientific aims and a defined statistical analysis plan. What ethical clearance is necessary? Proof of formal Institutional Review Board (IRB) or independent ethics committee approval from the requestor's home institution. What legal agreement must be signed? A legally binding Data Use Agreement (DUA) executed with Menoufia University to ensure strict patient confidentiality and prohibit any unauthorized dataset redistribution	Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol	6 month from 14/1/2026 to 14/7/2026	• Patients undergoing elective liver resection surgery. 1ry outcome 2ndry outcome
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
https://pactr.samrc.ac.za	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Target no of participants	07/07/2026	repeated sample size calculation	67	70
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Final no of participants	07/07/2026	repeated sample size calculation	65	70
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Inclusion criteria	07/07/2026	reviewer comment	• Patients undergoing elective liver resection surgery. • The age between of 21 and 65 years with a body mass index (BMI) of 18-35 kg/m2. • American Society of Anesthesiologists (ASA) class I-III. • Gender: both sexes	• Patients undergoing elective liver resection surgery. • The age between of 21 and 64years with a body mass index (BMI) of 18-35 kg/m2. • American Society of Anesthesiologists (ASA) class I-III. • Gender: both sexes
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Age group	17/07/2026	to include all age	Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s)	Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s)
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	07/07/2026	reviewer comment	OPD	in patient departement pt will undergoing liver resection
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	17/07/2026	reviewer comment	in patient departement pt will undergoing liver resection	in patient departement pt will undergoing liver resection Baseline Data: Patient demographics (age, sex) and clinical characteristics (Body Mass Index, ASA classification). Primary Outcome Data: Quantified total intraoperative opioid consumption and total postoperative nalbuphine consumption (measured in milligrams/micrograms) recorded over the first 24 hours post-surgery. Secondary Outcome Data: Analgesia Nociception Index (ANI) values recorded at baseline, post-induction, 10 minutes post-block, at skin incision, and every 15 minutes intraoperatively. Postoperative Visual Analogue Scale (VAS) pain scores assessed at arrival to the ward, and at 2, 6, 12, 18, and 24 hours postoperatively. Exact time elapsed (in minutes) from block administration to the patient's first request for rescue analgesia. Hemodynamic variables: Serial measurements of Heart Rate (HR) and Mean Arterial Pressure (MAP) across all intraoperative and postoperative tracking intervals
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD description	24/07/2026	Reviewer comment	in patient departement pt will undergoing liver resection Baseline Data: Patient demographics (age, sex) and clinical characteristics (Body Mass Index, ASA classification). Primary Outcome Data: Quantified total intraoperative opioid consumption and total postoperative nalbuphine consumption (measured in milligrams/micrograms) recorded over the first 24 hours post-surgery. Secondary Outcome Data: Analgesia Nociception Index (ANI) values recorded at baseline, post-induction, 10 minutes post-block, at skin incision, and every 15 minutes intraoperatively. Postoperative Visual Analogue Scale (VAS) pain scores assessed at arrival to the ward, and at 2, 6, 12, 18, and 24 hours postoperatively. Exact time elapsed (in minutes) from block administration to the patient's first request for rescue analgesia. Hemodynamic variables: Serial measurements of Heart Rate (HR) and Mean Arterial Pressure (MAP) across all intraoperative and postoperative tracking intervals	in patient departement pt will undergoing liver resection Baseline Data: Patient demographics (age, sex) and clinical characteristics (Body Mass Index, ASA classification). Primary Outcome Data: Quantified total intraoperative opioid consumption and total postoperative nalbuphine consumption (measured in milligrams/micrograms) recorded over the first 24 hours post-surgery. Secondary Outcome Data: Analgesia Nociception Index (ANI) values recorded at baseline, post-induction, 10 minutes post-block, at skin incision, and every 15 minutes intraoperatively. Postoperative Visual Analogue Scale (VAS) pain scores assessed at arrival to the ward, and at 2, 6, 12, 18, and 24 hours postoperatively. Exact time elapsed (in minutes) from block administration to the patient's first request for rescue analgesia. Hemodynamic variables: Serial measurements of Heart Rate (HR) and Mean Arterial Pressure (MAP) across all intraoperative and postoperative tracking intervals Patients undergoing elective liver resection surgery. Qualified academic researchers, clinical investigators, or biostatisticians with a verified institutional affiliation. What documentation is required? A methodologically sound, written research proposal detailing the specific scientific aims and a defined statistical analysis plan. What ethical clearance is necessary? Proof of formal Institutional Review Board (IRB) or independent ethics committee approval from the requestor's home institution. What legal agreement must be signed? A legally binding Data Use Agreement (DUA) executed with Menoufia University to ensure strict patient confidentiality and prohibit any unauthorized dataset redistribution
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD-Sharing time frame	17/07/2026	reviewer comments	6 month	6 month from 14/1/2026 to 14/7/2026
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Key access criteria	17/07/2026	reviewer comment	• Patients undergoing elective liver resection surgery.	• Patients undergoing elective liver resection surgery. Qualified academic researchers, clinical investigators, or biostatisticians with a verified institutional affiliation. What documentation is required? A methodologically sound, written research proposal detailing the specific scientific aims and a defined statistical analysis plan. What ethical clearance is necessary? Proof of formal Institutional Review Board (IRB) or independent ethics committee approval from the requestor's home institution. What legal agreement must be signed? A legally binding Data Use Agreement (DUA) executed with Menoufia University to ensure strict patient confidentiality and prohibit any unauthorized dataset redistribution
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Key access criteria	24/07/2026	Reviewer comment	• Patients undergoing elective liver resection surgery. Qualified academic researchers, clinical investigators, or biostatisticians with a verified institutional affiliation. What documentation is required? A methodologically sound, written research proposal detailing the specific scientific aims and a defined statistical analysis plan. What ethical clearance is necessary? Proof of formal Institutional Review Board (IRB) or independent ethics committee approval from the requestor's home institution. What legal agreement must be signed? A legally binding Data Use Agreement (DUA) executed with Menoufia University to ensure strict patient confidentiality and prohibit any unauthorized dataset redistribution	• Patients undergoing elective liver resection surgery. 1ry outcome 2ndry outcome
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	IPD URL	17/07/2026	reviewer comment	academic	https://pactr.samrc.ac.za
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Reporting	Study protocol document	07/07/2026	reviewer comment	Study Protocol	Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code

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