Hemanga K Bhattacharjee, MS, Virinder Bansal, MS, Azarudeen Jalaludeen, Subodh Kumar, MS, Asuri Krishna, MS, Rajeshwari Subramaniam, MD, Rashmi Ramachandran, MD, Mahesh Misra, MS. All India Institute of Medical Sciences
Laparoscopic cholecystectomy (LC) is the standard of care for gallstone disease. 30-60% of patients following LC suffer from shoulder pain in the immediate post-operative period. Exact mechanism of shoulder pain following LC is not well elucidated. This double blind randomized study is designed to evaluate the incidence and severity of shoulder pain following LC at low pressure and standard pressure pneumoperitoneum.
Materials and Methods
The study was conducted in a tertiary care referral hospital from November 2014 to September 2015. Consecutive patients undergoing LC for gallstone disease who met the inclusion criteria were enrolled. Sample size calculated was 80. 40 patients were randomized to Standard Pressure Laparoscopic Cholecystectomy (Group I – Pressure of 14 mmHg ) and 40 to Low Pressure Laparoscopic Cholecystectomy (Group II- Pressure of 9 -10 mmHg). Randomisation was done using computer generated random numbers, divided into blocks of eight. Sealed envelopes were used to conceal allocation. Data were collected in concurrence with CONSORT guidelines. Primary outcome measured was incidence of shoulder pain and its severity on Visual Analogue Scale (VAS) at 4, 8 , 24 hours and 7 days after LC. Secondary outcomes measured were duration of surgery, technical difficulty during LC, intra-operative variation in heart rate and blood pressure and post-operative abdominal pain. The patient and the resident who measured the pain were blinded about the allocated group.
A total of 170 LC were performed and 80 were randomised. All patients received the allocated treatment. There was no conversion to open surgery or major bile duct injury on either group. 23 patients (57.5%) in Group I and 9 patients (22.5%) in Group II had shoulder pain. This difference was statistically significant (p = 0.001). The severity of pain (VAS score, mean ± SD) at 4 hrs, 8 hrs, 24 hrs and 7 days following surgery were 0.125 ± 0.79, 1.8 ± 2.64, 2.35 ± 2.63 and 0, respectively in Group I and 0.125 ± 0.79, 0.7 ± 1.92, 0.925 ± 1.87 and 0 respectively in Group II. The difference was significant at 8 and 12 hrs after surgery (p = 0.009, 0.005). The difference in procedural time, technical difficulty, intra-operative variations in heart rate and blood pressure and post-operative abdominal pain were not significant.
Laparoscopic cholecystectomy with intra-abdominal pressure of 9-10mmHg significantly reduces the incidence and severity of post-operative shoulder pain. Performing LC at a lower intra-abdominal pressure is safe and effective.