| CTRI Number |
CTRI/2018/04/013276 [Registered on: 13/04/2018] Trial Registered Prospectively |
| Last Modified On: |
27/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
shoulder pain in gall bladder stone surgery |
|
Scientific Title of Study
|
Comparison of effect of standard-pressure and low-pressure pneumoperitoneum on shoulder pain following laparoscopic cholecystectomy |
| Trial Acronym |
splc |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Som Raj Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Dr. R.P.G.M.C, Tanda |
| Address |
Department of Surgery, Dr. Rajendra Prasad Government Medical College, Kangra at Tanda. kangra. Himachal Pradesh.
176001
India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418465057 |
| Fax |
|
| Email |
sommahajan1978@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Som Raj Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Dr. R.P.G.M.C, Tanda |
| Address |
Department of Surgery, Dr. Rajendra Prasad Government Medical College, Kangra at Tanda. kangra. Himachal Pradesh.
176001
India
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418465057 |
| Fax |
|
| Email |
sommahajan1978@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Mahajan |
| Designation |
Senior Resident |
| Affiliation |
Dr. R.P.G.M.C, Tanda |
| Address |
Department of Anaesthesia, Dr. Rajendra Prasad Government Medical College, Kangra at Tanda. kangra.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9781484200 |
| Fax |
|
| Email |
mon.mahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of surgery, Dr. Rajendra Prasad Government Medical College, Tanda at Kangra |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Surgery |
| Address |
Department of Anaesthesia and Surgery, Dr. RPGMC, Tanda, Kangra, HP |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Som Raj Mahajan |
Dr. RPGMC, Tanda |
surgery operation theatre, Department of Surgery and Anaesthesia
Kangra
HIMACHAL PRADESH |
9418465057
sommahajan1978@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| iInstitution ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing laparoscopic cholecystectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
effect of standard pressure with low pressure pneumoperitoneum on shoulder pain in laparoscopic cholecystectomy |
comparison of effect of the standard pressure (14 mm Hg) and low preesure (10 mm Hg) pneumoperitoneum on shoulder pain n patients undergoing laparoscopic cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
1. Patients with BMI > 30 kg/m2
2. ASA grade III and above
3. History of complicated gallstone diseases like cholangitis, pancreatitis,
4. History of previous malignancy or history of multiple abdominal surgery
5. Known shoulder disease
6. Patients who refuse to give informed consent
7. Patients in whom the laparoscopic procedure will be converted to open cholecystectomy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score of shoulder pain at 4 hr, 8 hr, 24 hr, 7day. rescue analgesic used and dose |
VAS score of shoulder pain at 4 hr, 8 hr, 24 hr, 7day. rescue analgesic used and dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| surgeon satisfaction and ease of instrument manoeuvrability , operating time, any technical difficulty- requiring additional ports or increase in intra-abdominal pressure, gall bladder perforation, spillage of stone, requirement of saline lavage, drain placement |
at induction, at start of aurgery, end of surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2018 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Laparoscopic cholecystectomy (LC) is the preferred surgical procedure for gall
stone disease. About 21% to 80 %
patients undergoing LC suffer from
shoulder pain (SP) in the early post-operative period, which can
lead to patient dissatisfaction and discomfort. The most common etiology of shoulder pain is due to
the stretching of peritoneum and diaphragmatic irritation by the carbon dioxide
pneumoperitoneum used for LC .
Pneumoperitoneum is created with the carbondioxide to inflate the abdomen. This allows the visualisation
of internal organs and provides adequate working space for instrument manoeuvrability.
Intra-abdominal pressure of 12–16 mm of Hg is accepted as standard
intra-peritoneal pressure for adequate working space and organ visualisation. Increased intraabdominal pressure may also have negative implications on
cardiovascular, pulmonary, and intraabdominal organ functionings. Attempts are being
made to reduce the incidence of shoulder pain by keeping the intra-abdominal
pressure at a lower level. In literature, low-pressure PNP is generally defined
as an intraabdominal pressure of 6–10 mmHg.11 The main criticism of
low pressure pneumoperitoneum is its ability to provide adequate surgical
exposure and hence its safety.
The
present randomised study is designed to evaluate the impact of intra-abdominal
pressure on post-operative pain and surgeons’ satisfaction in LC. |