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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   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
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

 
 
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    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 
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