Comparison of Low Pressure Pneumoperitoneum with Standard Pressure Pneumoperitoneum to determine which one is better regarding pain experienced by patient in post operative period
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/11/059491
- Lead Sponsor
- PGIMER Chandigarh Adminitration
- Brief Summary
Laparoscopiccholecystectomy has replaced conventional cholecystectomy as there are limitedsurgical incisions, decreased post-operative stay, less post-operative pain anddecreased need for post-operative analgesia4-6.
Traditionally, one ofthe first steps in laparoscopic cholecystectomy is the creation ofpneumoperitoneum7 using carbon dioxide (CO2) throughVeress needle8 or through a port (hole) in the abdominal wall.Traditionally, the pressure used is around 15mm Hg (12-16 mm Hg)9.
The commonly seencomplications due to pneumoperitoneum are shoulder tip pain and cardiopulmonarychanges. These changes seen are directly due to pressure effects on peritoneumand diaphragm and indirectly due to absorbed carbon dioxide and hypercarbia,leading to local peritoneal acidosis, increased intrathoracic pressure,decreased venous return, and decreased cardiac output. These complications maybe well tolerated by healthy and young individuals but lead to significantcomplications in old and those who have underlying cardiopulmonary diseases.
The increase inintrathoracic pressure depends to some extent on the pressure maintained inpneumoperitoneum due to upward compressive effects of diaphragm. This ledresearchers to think in term of low-pressure pneumoperitoneumcholecystectomies.
Internationalguidelines recommend that the use of “the lowest intra-abdominal pressureallowing adequate exposure of operative field rather than a routine pressureâ€should be used to minimize the impact of pneumoperitoneum on normal physiologyand the positive impact on postoperative pain10. Low pressurepneumoperitoneum is defined as a pressure of 6-10mm Hg11. The mainconcern about low pressure pneumoperitoneum is its safety in terms ofinadequate exposure resulting in longer than usual operating time, increasedrate of intra-operative complications and also possibly increased frequency ofconversion to open cholecystectomy12. Therefore, attempts are madeto use low pressure pneumoperitoneum in range of 6-10mm Hg in an attempt tominimize alteration of normal physiology and simultaneously to provide anadequate working space.
In present studyoutcome of the use of low-pressure pneumoperitoneum (LPP defined as 8-10mm Hgin our study) in comparison to the use of standard pressure pneumoperitoneum(SPP defined as 13-15mm Hg in this study) in patients undergoing laparoscopiccholecystectomy are studied.
Theaim of the current study is to evaluate and compare the effects and outcomes ofLPP versus SPP in laparoscopic cholecystectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 90
1.All patients with symptomatic GSD with chronic cholecystitis undergoing elective laparoscopic cholecystectomy 2.Age: 18years- 65 years.
1.Patients not giving consent for undergoing study 2.Patients with other preoperative causes of shoulder pain like bursitis, rheumatoid arthritis, tendinitis and other musculoskeletal conditions 3.Patients with CAD, COPD, Asthma, previous malignancy, jaundice or any other co-morbidity 4.Patients who have underwent any abdominal surgery previously 5.BMI<18.5 or BMI>29.9 6.Patients on chronic analgesic use or patients with history of addiction to alcohol 7.Patients with significant portal hypertension, uncorrectable coagulopathies, cirrhosis and generalized peritonitis 8.Pregnant patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence & intensity of post-operative pain & analgesic requirement in LPP group & SPP group 6hrs 12hrs 24 hrs
- Secondary Outcome Measures
Name Time Method duration of procedure At end of surgery surgical field visualization At end of surgery incidence of intra-operative complications At end of surgery Effect of pneumoperitoneum on Intra-operative physiology i. At insufflation of pneumoperitoneum duration of hospital stay & time taken for return to work Up to 30 days after surgery
Trial Locations
- Locations (1)
Postgraduate Institute of Medical Education and Research, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Postgraduate Institute of Medical Education and Research, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaVishesh GuptaPrincipal investigator9899633836vishesh.gupta65@gmail.com