Routine abdominal drainage after laparoscopic cholecystectomy is an issue of considerable debate. One of the reasons for drain placement is to allow CO2 insuflated during laparoscopy to escape via drain site thereby decreasing shoulder tip pain and post-operative nausea and vomiting. But some studies show no difference in post-operative nausea/vomiting/pain between drain and no drain group.

HYPOTHESIS

Post laparoscopic cholecystectomy, shoulder tip pain is likely due to irritation of the diaphragm by the carbon dioxide used in the procedure. Intra peritoneal drain will evacuate this accumulated carbon dioxide and thus reduce the incidence and intensity of shoulder tip pain.

REVIEW OF LITERATURE

Laparoscopic cholecystectomy (LC) is the most popular laparoscopic surgery worldwide and has evolved to become the standard treatment for symptomatic calculous and acalculous cholecystitis (1). LC has several advantages, including smaller wounds, fewer post-operative respiratory complications and shorter convalescence and duration of hospital stay. Post- laparoscopic shoulder pain (PLSP), however, is an easily neglected but not a rare complaint following LC, with a reported incidence of up to approximately 50%. Its symptom not only leads to greater discomfort and anxiety during recovery periods, but also prolongs hospitalisation and can even result in readmission (2). Thus, finding methods to reduce PLSP after LC is central to be explored. Surgical drains are generally used in abdominal surgeries for therapeutic purposes, including to monitor the drainage of abdominal effusion in order to avoid bleeding or the formation of intra-abdominal abscesses, and to remove debris; however, the use of surgical drain is related to increasing wound infection rates and more postoperative abdominal pain. Notably, residual intra-peritoneal gas is also evacuated through a drain. Evidence suggests that the mechanism of PLSP concerns the irritation of the phrenic nerve by residual gas inflation during laparoscopic surgery, although the complete mechanism of PLSP remains unclear (3,4). Remarkably, several studies have shown that patients with a drain have less PLSP after a laparoscopic procedure, suggesting that carbon dioxide (CO2) following out via the site of the drain might decrease the irritant effects of residual gas in the peritoneal cavity (9–11). However, other studies have reported different results showing that a drain does not affect PLSP incidence after LC (12,13). The role of drains in reducing PLSP after LC, therefore, still remains controversial.

Our hypothesis was that the placement of surgical drain reduced PLSP in the early postoperative periods. The objective of this prospective cohort study was to examine

whether the use of a drain reduces the incidence or severity of PLSP in the first 24 h after LC.

AIMS AND OBJECTIVES

Primary Objective:

To evaluate the role of an intra-peritoneal passive polypropelene drain on frequency of shoulder pain after laparoscopic cholecystectomy

Secondary objective:

To assess the role of an intra-peritoneal passive polypropelene drain on intensity of shoulder pain after laparoscopic cholecystectomy

Study site – department of general surgery of IGIMS, Patna

Primary outcome measure – proportion of patients perceiving pain in shoulder following laparoscopic cholecystectomy

Secondary outcome measures – Intensity of pain in shoulder as measured by VRS Duration of pain in shoulder after surgery

Sample size – Considering the type-1 error as 5%, power as 80%, enrollment ratio 1:1, assuming proportion of patients having pain without drain 0.3 and proportion of patients having pain with drain 0.15, based on previous few studies; the total sample size is estimated to be 240. In each of the two groups, 120 patients would be recruited. The Epi-Info version 6 was used for calculation. As there is no scope of attrition so there is no need for any change or correction.

Study population – consenting patients undergoing laparoscopic cholecystectomy

Inclusion criteria:

All consenting males and females admitted for routine laparoscopic cholecystectomy

Exclusion criteria:

Pregnant females

Intra operative major complications like biliary tract injury and massive bleeding

History of shoulder pain History of upper laparotomy Conversion to laparotomy

Duration of study 1 year In case, sufficient recruitment cannot be done, study period might be extended.

Materials and Methods

All patients admitted for laparoscopic cholecystectomy and fulfilling the inclusion and exclusion criteria will be included in the study. The patients will be randomised into two groups (cases and control) by simple random sampling. Patients will undergo laparoscopic cholecystectomy. At the end of the procedure in the cases group an intraperitoneal drain will be affixed, whereas in the control no drain will be inserted. All patients will be given routine . At 12 hours and 24 hours’ post-operative patients will be asked for shoulder pain and they have to score it according to Verbal Rating Score (VRS). Additional details like analgesia required, post-operative stay, nausea, abdominal pain will be noted. Drains will be removed 24 hours’ post-operative. The results will be tabulated and analysed.

Plan of analysis:

The data would be collected in CRF and transcribed in MS Excel datasheet. The difference on frequency of pain would be analyzed by Chi-square test and intensity of pain by Unpaired t test following test of normality.

A total of 244 patients who underwent laparoscopic cholecystectomy were enrolled in this study. Of these, 4 patients were excluded as they converted to laparotomy. 240 complete sets of data were available for analysis, 120 in the placebo group and 120 in the drain group.

Numbers in parentheses are the range.

Data presented as the mean of standard deviation, unless otherwise noted.

Table shows the demographic and operative data available for the two groups. No

statistically significant difference was found in age, body mass index or co-morbidities. Also, no statistically significant difference was found between the two groups in regard to the volume of carbon dioxide used to insuflate the peritoneal cavity or the length of the procedure.

Numbers in parentheses are the range of values or percentage of total sample size in each group.

Statistically significant differences were noted between the drain group and placebo group for post-operative shoulder pain frequency at twelve and twenty-four hours (18.33% versus 30.83% and 5.83% versus 16.66% respectively) as well as median pain intensity scores on VRS (2 versus 4 and 1 versus 3). Drain group also had reduced complaints of abdominal pain as compared to placebo group (21.66% versus 36.66%). Median duration of stay in drain group was 2 days as compared to 3 days in the placebo group. No statistically significant difference was found in incidence of PONV and analgesic requirements among the two groups.

Pain is a common complaint in the post-operative period after laparoscopic cholecystectomy and the ability to alleviate it by simple and inexpensive measures would be beneficial to both the surgeon and the patient. The site of pain varies from patient to patient and is most commonly reported in the abdomen, shoulder tip and the back. Shoulder pain has been reported in up to 66%(10,11) patients although it is usually transient and disappears within 24-72 hours(12-13). Distension of the abdomen alone is thought to be enough to cause pain. One study has reported that lowering intra-abdominal pressure during laparoscopic surgery is associated with less pain(14), although one-fourth of the cases in the study were converted to high-pressure due to inadequate vision associated with low pressure(15). Another study showed a decreased incidence of shoulder pain with a low gas insuflation rate. The chemical conversion of carbon dioxide to carbonic acid on the moist peritoneal surfaces is hypothesised to cause pain; however, trials comparing insuflation with nitrous oxide versus carbon dioxide in an attempt to decrease post-operative pain failed to show differences between the two gases.(16,17) One study reported a 50% reduction in pain when a drain was used in the postoperative period to remove residual gas, although this was not statistically significant.(18) Our study found a statistically significant difference between a drain and placebo for the reduction of shoulder pain frequency and intensity as well as abdominal pain frequency but not for nausea and dose of analgesic required. The frequency and intensity of shoulder pain was reduced significantly in the group using a drain. This suggests that a relationship may exist between shoulder pain and the amount of residual gas in the peritoneal cavity as has been previously reported.(19) The drain group received

analgesia on a PRN basis whereas the placebo group needed a more regular twelve hourly dosage of analgesics to alleviate pain, although this association was not statistically significant. The duration of hospital stay was reduced significantly in the drain group as compared to the placebo group. In conclusion, the use of an intraperitoneal drain reduces the frequency and intensity of shoulder pain as well as abdominal pain apart from reducing the duration of hospital stay but works little to reduce nausea and analgesic requirements.

Ours was a prospective cohort study designed to investigate the association between intraperitoneal drain use and Post Laparoscopy Shoulder Pain to explain the effect of residual intraperitoneal gas in patients undergoing Laparoscopic Cholecystectomy. Our results show that surgical drain use reduces the frequency and intensity of PLSP in the first 24 h after LC. This suggests that techniques to evacuate residual gas completely at the end of laparoscopic procedures can reduce PLSP.

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