| CTRI Number |
CTRI/2016/02/006590 [Registered on: 01/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
14/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of shoulder pain following laparoscopic cholecystectomy under standard or low intra-abdominal gas pressure |
|
Scientific Title of Study
|
IMPACT OF STANDARD PRESSURE AND LOW PRESSURE PNEUMOPERITONEUM IN SHOULDER PAIN FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY: A DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemanga K Bhattacharjee |
| Designation |
Assistant Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi
South DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
dr_hkb75@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Azarudeen Jalaludeen |
| Designation |
Junior Resident of Surgery |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi
South DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
azrudn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Hemanga K Bhattacharjee |
| Designation |
Assistant Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines, All India Institute of Medical Sciences, New Delhi
South DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
dr_hkb75@yahoo.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, India |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar
Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hemanga K Bhattacharjee |
Department of Surgical Disciplines |
All India Institute of Medical Sciences, Ansari Nagar, Delhi-110029 South DELHI |
7838621462
dr_hkb75@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing laparoscopic cholecystectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic cholecystectomy |
NIL |
| Comparator Agent |
Laparoscopic cholecystectomy performed under standard pressure and low pressure pneumoperitoneum |
Standard pressure pneumoperitoneum defined as cabondioxide pneumoperitoneum of 14mm Hg.
Low pressure pneumoperitoneum defined as carbondioxide pneumoperitoneum of 9-10mm Hg |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
All consecutive patients (adult male and females > 18 and <60 years old) admitted for laparoscopic cholecystectomy
Exclusion Criteria
1. ASA grade IV and V
2. BMI >30 kg/m2.
3. history of ERCP and stent in situ.
4. known shoulder disease
5. history of acute cholecystitis, cholangitis and pancrreatitis
6. history of multiple abdominal surgery
7. uncorrectable coagualopathy
8. significant co-morbidities like coronary artery disease, asthma, COPD, and previous malignancy.
9. Patients requiring other concomitant procedures.
10. Patients who do not give consent for participation in the study or patient with cognitive impairments
11. Patients on chronic analgesic use
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. ASA grade IV and V
2. BMI >30 kg/m2.
3. history of ERCP and stent in situ.
4. known shoulder disease
5. history of acute cholecystitis, cholangitis and pancrreatitis
6. history of multiple abdominal surgery
7. uncorrectable coagualopathy
8. significant co-morbidities like coronary artery disease, asthma, COPD, and previous malignancy.
9. Patients requiring other concomitant procedures.
10. Patients who do not give consent for participation in the study or patient with cognitive impairments
11. Patients on chronic analgesic use
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of shoulder pain on Visual Analogue Scale |
4, 8, 24 hours and 7 days after Laparoscopic Cholecystectomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of surgery
2. Surgeons satisfaction score
3. Technical difficulty
4. Abdominal pain on VAS
score
5. Intra-operative changes in heart rate and blood pressure
|
Abdominal pain is measured by VAS at 4, 8, 24 hours and 7 days after laparoscopic
cholecystectomy
Intra operative changes in heart rate and blood pressure at every five minutes interval
|
|
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Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
03/11/2014 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Laparoscopic cholecystectomy is the standard of care of gall stone disease.However there are certain issues which although not life threatening, cause considerable post operative discomfort and anxiety to the patient. Post operative shoulder pain is one of such issue. 30-50% of patients of laparoscopic choecystectomy suffer from shoulder pain in the immediate post operative period. It commonly occurs in the first post operative day, although, it may persist for several days.. As the location of the pain is far from the surgical site, it causes considerable anxiety to the patients. It also prolongs the hospital stay. Shoulder pain is a unique complication following laparoscopic cholecystectomy. It is never seen following open surgery. Thus it appears to be an inherent problem associated with laparoscopy itself. The exact pathophysioslogy of shoulder pain following laparoscopic cholecystectomy is not well elucidated. Several hypotheses have been proposed. The most thought about hypothesis is that, pneumoperitoneum, in which cabondioxide gas (CO2) is used to inflate the abdomen, inflicts stretching trauma to the diaphragm and the peritoneum. This in turn causes referred pain to the shoulder (C4 distribution). The other possible theories are irritating effects of CO2 on the peritoneum and loss of suction effect between liver and diaphragm due to remaining pockets of CO2 gas. Pneumoperitoneum i.e. insufflations of abdominal cavity with CO2 gas is a primary step of all laparoscopic procedures. Pneumoperitoneum inflates the abdominal cavity thus provides working space for manipulation of laparoscopic instruments and aids in visualization of the internal organs. Commonly the intra-abdominal pressure is kept at around 14 mm Hg and it provides adequate working space and endoscopic visualization of the internal organs to the operating surgeon. However, it is hypothesized that this range of pressure causes stretching of the diaphragm injuring small vassels, nerves and muscle fibres and liberates inflammatory cytokines. Overall impacts of all these is referred pain along the C4 distribution, causing pain over the shoulder joint. Several attempts have been made to reduce the incidence and severity of shoulder pain following laparoscopic cholecystectomy which include, maintaining low pressure pneumoperitoneum during the procedure , keeping a drainage in the abdominal cavity to remove the residual air, abdominal wall lift, use of nitrous oxide instead of CO2, active gas aspiration, pulmonary recruitment manoeuvre, intra-peritoneal normal saline instillation and low insufflation rate. Among all these, low pressure pneumoperitoneumn, low insufflations rate and pulmonary recruitment manueuvre are found to be effective in reducing the incidence of post operative shoulder pain Several range of pressure have been tried to reduce the incidence of shoulder pain. Arbitrarily, a pressure range of 12-16mmHg has been designated as standard pressure and pressure less than 12 mmHg is termed as low pressure pneumoperitoneum. The result of randomized trials comprising low pressure pneumoperitoneum and standard pressure pneumoperitoneum in reducing the incidence and severity of shoulder pain is variable. A few trials have shown significant reduction in incidence of shoulder pain, while a few others have failed to show any major change. A chocrane meta-analysis of four randomized control trial showed significant reduction of incidence of shoulder pain following low pressure pneumoperitoneum. Another recent meta-analysis also favour use of low pressure (10mmHg) for pneumoperitoneum to reduce the incidence of shoulder pain. One major concern for adopting low pressure pneumoperitoneum for regular laparoscopic procedure is its possible negative effect on working space and visualization of internal organs. In other words, will low pressure pneumoperitoneum compromise the safety of the procedure? The Cochrane analysis showed that the low pressure pneumoperitoneum prolonged the operation time by 2 minutes. However there was no difference in surgical complications rate or nor in the rate of conversion to open surgery. Thus it is imperative that low pressure pneumoperitoneum may be as safe as standard pressure pneumoperitoneum. However, no studies have systematically evaluated the surgeosn’s satisfaction pertaining to exposure and working space during laparoscopic cholecystecotmy at low pressure. The present work is designed to evaluate the incidence and severity of shoulder pain following laparoscopic cholecystectomy at low pressure and standard pressure pneumoperitoneum as the primary end point. The patient and the doctor accessing pain will be blinded about the allocated group of the patient. The secondary end points will be to assess the operating time, surgeons satisfaction score pertaining to pneumoperitoneum, technical difficulty, changes in intra-operative heart rate and blood pressure and post operative abdominal pain. |