| CTRI Number |
CTRI/2026/03/105854 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Ways of Port Placement in Gallbladder Surgery: Which Is Less Painful? |
|
Scientific Title of Study
|
Effect of Ultrasound Guided vs Conventional Port Placement on Postoperative Port-Site Pain in Laparoscopic Cholecystectomy: A Single Blinded Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Mishra |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9015743933 |
| Fax |
|
| Email |
mishradivya8801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Gupta |
| Designation |
Associate Professor General Surgery |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9453302264 |
| Fax |
|
| Email |
ravikgmc2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Gupta |
| Designation |
Associate Professor General Surgery |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9453302264 |
| Fax |
|
| Email |
ravikgmc2004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat Gorakhpur Uttar Pradesh India 273008 |
|
|
Primary Sponsor
|
| Name |
Dr Divya Mishra |
| Address |
Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat Gorakhpur Uttar Pradesh India 273008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Mishra |
All India Institute of Medical Sciences (AIIMS) Gorakhpur |
Departmental Office Department Of General Surgery First Floor OPD Building Gorakhpur
Gorakhpur
UTTAR PRADESH |
9015743933
mishradivya8801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (4) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Port Placement |
Patients allocated to the comparator arm will receive conventional port placement based on standard surface anatomical landmarks without ultrasound guidance. To maintain participant blinding false ultrasound markings will be performed. Port placement will follow routine institutional practice and the remainder of the surgical procedure will be identical to the intervention group. |
| Intervention |
Ultrasound Guided Port Placement |
Patients allocated to the intervention arm will receive ultrasound-guided port placement. After randomization preoperative ultrasound mapping of the abdominal wall will be performed to identify neurovascular bundles. Port placement (anterior axillary and subcostal ports) will be performed between identified neurovascular bundles to minimize tissue trauma. The rest of the surgical procedure will be performed according to standard laparoscopic cholecystectomy protocols. The primary outcome of the study is postoperative port-site pain which will be assessed using the Visual Analogue Scale (VAS). Pain scores will be recorded at 2 6 12 24 and 48 hours following surgery. Secondary outcomes include total postoperative analgesic requirement within the first 48 hours, time to first postoperative ambulation incidence of port-site complications such as bleeding hematoma seroma and surgical site infection up to postoperative day 30 and length of hospital stay. It is expected that ultrasound-guided port placement will result in lower postoperative port-site pain reduced analgesic requirement earlier ambulation and fewer port-site complications compared to conventional port placement. The findings of this study may support the routine use of ultrasound guidance for safer port placement in laparoscopic cholecystectomy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult patients aged between 18 and 60 years
2) American Society of Anaesthesiologists (ASA) physical status classification of I to III
3) Scheduled for elective LC
4) Patients who provide informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency laparoscopic procedures will be excluded.
Individuals with a history of previous upper abdominal surgery or trauma will be excluded.
Patients with known coagulopathies, defined as an International Normalized Ratio greater than 1.5 or a platelet count below 50,000, will be excluded.
Pregnant females will be excluded.
Patients with morbid obesity, defined as a body mass index equal to or greater than 35 kilograms per square meter, will be excluded.
Patients with cognitive impairment or inability to provide informed consent will be excluded.
Patients who are unable to comprehend or use the Visual Analogue Scale for pain assessment will be excluded.
Patients with local skin infection at the proposed port sites will not be enrolled.
Cases requiring open conversion during surgery will be excluded.
Patients on long term medications that may alter pain perception, such as antidepressants, aspirin, antipsychotics, anticonvulsants, or lithium, will be excluded.
Patients with neuropathic disorders, such as diabetic neuropathy, will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of Port-Site Pain |
Pain severity will be measured using the Visual Analog Scale at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours postoperatively, and will be compared with patients who receive conventional port placement. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesic Requirement for Port Site Pain |
As a direct consequence of lower pain scores, it is expected that the ultrasound guided group will require a lower total dose of postoperative analgesic medication within the first 48 hours. |
| Port-Site Complications |
To compare port site complications, including hematoma, infection, bleeding, and seroma, up to postoperative day 30. |
| Time to first ambulation |
With less pain and fewer complications, patients in the ultrasound guided group are expected to achieve their first successful ambulation earlier after surgery. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, single centre, single blinded randomized controlled trial conducted at All India Institute of Medical Sciences, Gorakhpur. The aim is to compare ultrasound guided port placement with conventional port placement in patients undergoing elective laparoscopic cholecystectomy.
A total of eligible adult patients will be randomly allocated into two groups, namely the ultrasound guided group and the conventional group. Pain severity will be assessed using the Visual Analogue Scale at 2, 6, 12, 24, and 48 hours after surgery. The primary objective is to determine whether ultrasound guided port placement reduces postoperative port site pain within the first 48 hours.
Secondary objectives include comparison of total postoperative analgesic requirement, time to first ambulation, and incidence of port site complications such as hematoma, bleeding, infection, and seroma up to postoperative day 30.
The study is expected to demonstrate that ultrasound guided port placement reduces postoperative pain, decreases analgesic consumption, lowers complication rates, and facilitates earlier ambulation, thereby improving overall recovery and potentially influencing future surgical practice. |