Affiliations
doi: 10.29271/jcpsppg.2025.01.98ABSTRACT
Objective: To compare the incidence of shoulder tip pain (STP) after laparoscopic cholecystectomy (LC) in patients with and without subhepatic drain.
Study Design: A quasi-experimental study.
Place and Duration of the Study: Department of General Surgery, Pak Emirates Military Hospital, Rawalpindi, Pakistan, from November 2023 to October 2024.
Methodology: One hundred patients underwent LC for symptomatic cholelithiasis and were segregated into two groups: Group A had a subhepatic drain placed, and Group B did not. Patients underwent surveillance after the procedure, and results were established. Statistical Package for the Social Sciences (SPSS) version 23 was utilised for analysing the data. The Chi-square test was applied to compare categorical variables. The Mann-Whitney U test was used to compare non-normally distributed data. A significant p-value was defined as <0.05.
Results: One hundred patients were equally segregated into both groups. The mean age of all patients was 43.30 ± 0.59 years, with 42 (42%) males and 58 (58%) females. The median operative time was 50 (10) minutes with a drain and 45 (11) minutes without a drain (p = 0.04). After 24 hours of surgery, 4 (8%) patients with a drain and 6 (12%) patients without a drain had nausea/vomiting (p = 0.73), whereas 48 hours after surgery, 4 (8%) patients with a drain and 2 (4%) without a drain had nausea/vomiting (p = 0.67). After 24 hours of surgery, STP was present in 3 (6%) patients with a drain and in 1 (2%) patient without a drain (p = 0.61), whereas at 48 hours, STP was recorded in 3 (6%) patients with a drain and in 6 (12%) patients without a drain (p = 0.48).
Conclusion: Routine placement of subhepatic drain after LC does not offer any significant benefit to reduce postoperative STP.
Key Words: Cholecystectomy, Drain, Laparoscopic, Pain, Shoulder.
INTRODUCTION
Gallstones (cholelithiasis) represent one of the most frequently encountered conditions treated by general surgeons worldwide. It is a highly prevalent condition affecting approximately 10-20% of the global population.1 Laparoscopic cholecystectomy (LC) is currently considered the gold standard surgical treatment for symptomatic cholelithiasis.2,3 As compared to open surgery, it is a minimally invasive technique that provides better cosmesis, less post-surgery pain, and early return to normal routine activities.4
Carbon dioxide gas is used to create pneumoperitoneum during laparoscopic surgery, and the intra-abdominal pressure is kept at 12-14 mmHg to avoid haemodynamic changes.5
It is believed that after laparoscopic surgery, retained subdiaphragmatic intra-abdominal gas can irritate the diaphragm, leading to nausea, vomiting, and referred shoulder tip pain (STP).6 Surgeons believe that various strategies, such as keeping low-pressure pneumoperitoneum and reducing the duration of surgery, can help to prevent STP.7 Some surgeons also place a subhepatic drain during LC to evacuate the collected intra-abdominal gas and prevent STP. However, others think that it does not offer any advantage in reducing STP, and it may enhance pain at the drain site and cause unnecessary discomfort for the patient. A prospective cohort study conducted in Taiwan concluded that drains reduce the incidence of STP, and their routine use for this purpose is justified.8 Another randomised controlled trial (RCT) conducted in China documented that routine use of drainage after uncomplicated LC does not offer any advantage in terms of STP and nausea/ vomiting.9 A meta-analysis conducted in Italy concluded that in uncomplicated LC, drains do not offer any benefit to reduce postoperative complications.10
Due to this discrepancy in the available literature, surgeons in various parts of the world follow different practices, depending on departmental guidelines and personal experiences. Very limited literature is available with respect to the local population of the authors’ country. Therefore, this study was conducted to evaluate the role of drain placement after LC in preventing STP in the local population.
METHODOLOGY
A quasi-experimental study was carried out at the Department of General Surgery, Pak Emirates Military Hospital, Rawalpindi, Pakistan, from November 2023 to October 2024. The Ethical Review Board's approval (Serial No: A/28/ERC/44/2025) was acquired. To calculate sample size, the WHO sample size calculator was used, utilising the following parameters: 10% level of significance, 90% power of the test, STP with a drain 32% and without a drain 10%.11 Based on these, the calculated sample size was 114. However, out of these, 14 patients were excluded from the study due to intraoperative complications, difficult surgery, or conversion to open surgery, which resulted in 100 patients overall (50 in each group). This information in displayed in Figure 1.
Figure 1: Patient flow diagram (n = 100).
The authors included adult patients aged between 18 and 60 years, having American Society of Anesthesiologists (ASA) grade I and II, who presented to the outpatient department (OPD) and were diagnosed with cholelithiasis.
The authors excluded the patients with calculous cholecys- titis, biliary pancreatitis, choledocholithiasis, gallbladder mass, empyema gallbladder, gallbladder perforation, and liver abscess. Patients with sepsis, chronic liver/renal disease, liver cirrhosis, malignancy, congestive cardiac failure, compromised immunity, or who underwent radiotherapy/chemo- therapy were excluded, from the study. Patients with any psychological or neurological disorder were also excluded, as were the non- consenting patients.
The participants reported to the OPD with the clinical features of symptomatic cholelithiasis. Medical history was obtained from the patients. A clinical examination was also performed. Abdominal ultrasound was advised, and laboratory investigations (Complete Blood Picture [CBC], C-reactive protein [CRP], and liver function tests) were obtained. Diagnosis of symptomatic gallstones was made using history, clinical examination, and radiological (ultrasound) workup. Body mass index (BMI) was calculated and obesity (BMI ≥30) was documented. Elective LC was planned after pre-anaesthesia assessment. Participants were told of the research's goal, and their informed written consent was acquired. Participants were divided into two equal groups (Group A and Group B) based on sequential sampling. All surgeries were performed under general anaesthesia (GA) by the trained laparoscopic surgeons of the same team following similar operative principles. A single broad-spectrum intravenous antibiotic (injection ceftriaxone 1g) was administered at the time of induction of anaesthesia. Pneumoperitoneum was created using carbon dioxide gas, keeping the pressure at 12-14 mmHg. The Modified-Hasson technique was used to create pneumoperitoneum. All surgeries were performed using the standard 4-port technique. A 10 mm infra-umbilical optical port was used for the telescope. The other three ports were used for working instruments and fundus retraction. Nassar's operative difficulty score, which is a validated grading system based on intraoperative findings such as adhesions, gallbladder condition, and anatomical variations, was used to assess the technical difficulty of LC. The scale ranges from Grade I (very easy) to Grade IV (extremely difficult).12 Grade IV gallbladders were excluded from the study. Moreover, any unexpected intraoperative complication or conversion to open surgery resulted in exclusion from the study. Subtotal cholecystectomy was performed in case of the frozen Calot’s triangle, and it also resulted in removal from the study. After the successful removal of the gallbladder, a subhepatic drain was placed in Group A patients, and no drain was placed in Group B patients. Valves of the laparoscopic ports were then opened to allow the gas to escape the abdomen. Sufficient time was allowed to let the distended abdomen settle down to its normal anatomical position after the removal of the gas. Moreover, a controlled, gentle pressure was applied over the abdomen to push out any retained air. The timings of all surgeries were recorded. After the surgery, all patients were shifted to the ward. In the postoperative period, patients were administered intravenous analgesia (injection paracetamol 1g 8 hourly) and intravenous anti-emetic (injection ondansetron 8 mg, 8 hourly). The routine postoperative antibiotics were not administered unless any unexpected contamination or bile leak occurred. The incidence of nausea/vomiting at 24 hours and 48 hours after surgery was recorded. The presence of STP at 24 hours and 48 hours after surgery was also documented. Length of stay (LOS) in the hospital and patient satisfaction were also recorded.
The Statistical Package for Social Sciences (SPSS) version 23 was utilised to evaluate the results. Categorical variables (gender, obesity, STP, nausea/vomiting, and satisfaction) were expressed as frequencies and percentages. The Chi-square test was applied to compare the categorical variables. The Shapiro-Wilk test assessed the normal distribution of the quantitative data. The Mann-Whitney U test was used to compare the non-normally distributed data. A significant p-value was defined as <0.05.
Table I: Comparison of baseline characteristics (n = 100).
|
Characteristics |
Group A (n = 50) |
Group B (n = 50) |
p-values |
|
Age (years), Mean ± SD |
41.46 ± 5.52 |
45.14 ± 5.93 |
0.002 |
|
Gender, n (%) |
|
|
|
|
Male |
21 (42%) |
21 (42%) |
>0.99 |
|
Female |
29 (57.99) |
29 (57.99) |
|
|
Obesity, n (%) |
8 (16%) |
5 (10%) |
0.37 |
Table II: Comparison of operation times and postoperative outcomes (n = 100).
|
Outcomes |
Group A (n = 50) |
Group B (n = 50) |
p-values |
|
Operation time (minutes), Median (IQR) |
50 (10) |
45 (11) |
0.04 |
|
Nausea/vomiting - 24 hours, n (%) |
4 (8%) |
6 (12%) |
0.73 |
|
Nausea/vomiting - 48 hours, n (%) |
4 (8%) |
2 (4%) |
0.67 |
|
STP - 24 hours, n (%) |
3 (6%) |
1 (2%) |
0.61 |
|
STP - 48 hours, n (%) |
3 (6%) |
6 (12%) |
0.48 |
|
The Chi-square test was applied to determine the p-value of the qualitative variables, and the Mann-Whitney U test was applied to determine the p-value of the qualitative variables. |
|||
Table III: Comparison of length of stay in hospital and patient satisfaction among the two groups (n = 100).
|
Outcomes |
Group A n (50) |
Group B n (50) |
p-values |
|
Length of stay in hospital, days (mean ± SD) |
2.10 ± 0.41 |
2.04 ± 0.19 |
0.36 |
|
Satisfaction, n (%) |
48 (96%) |
49 (98%) |
0.55 |
|
The Chi-square test was applied to determine the p-value of the qualitative variables, and the Independent sample t-test was applied to determine the p-value of the qualitative variables. |
|||
RESULTS
One hundred patients were included, with 42 (42%) males and 58 (58%) females. The mean age of the patients was 43.30 ± 0.59 years. Obesity was observed in 13 (13%) patients. Table I displays a comparison of the baseline attributes.
The median operation time of patients was 50 (10) minutes with a drain, and 45 (11) minutes without a drain (p = 0.04). At 24 hours after surgery, four (8%) patients with a drain and six (12%) without a drain had nausea/vomiting (p = 0.73). At 48 hours after surgery, four (8%) patients with a drain and two (4%) without a drain had nausea/vomiting (p = 0.67). At 24 hours after surgery, STP was present in six (6%) patients with a drain and one (2%) patient without a drain (p = 0.61). At 48 hours after surgery, STP was recorded in three (6%) patients with a drain and six (12%) patients without a drain (p = 0.48) as shown in Table II.
The mean LOS in the hospital was 2.10 ± 0.41 days for patients with a drain, and 2.04 ± 0.19 days for patients without a drain (p = 0.36). Forty-eight (96%) patients with a drain were satisfied with the treatment, and 49 (98%) patients without a drain were satisfied (p = 0.55), as demons-trated in Table III.
DISCUSSION
LC is the surgical treatment for various gallbladder pathologies. A subhepatic drain is usually placed during the surgery if any bile leakage or blood collection is expected in the postoperative period. Drain helps in early diagnosis of any injury that might have occurred during the surgery and may also play a therapeutic role in preventing biliary peritonitis. However, the role of routine subhepatic drains in the cases of simple, uncomplicated LC is controversial. Some surgeons favour the routine use of a drain to remove any residual gas from the abdomen to reduce the incidence of STP and nausea/vomiting. However, this practice is challenged by many surgeons who believe that it only increases the drain site discomfort and LOS in the hospital without providing any significant benefit, especially when intraoperative findings are clean, and no visible spillage or bleeding is encountered during the procedure.
In the present study, the majority of participants were female. Baddam et al. conducted a study and documented that cholelithiasis is more common in females.13 The majority of participants were in their 40s in the present study. Hussain and Al-Jashamy documented in their study that the age range of 40-49 years had a greater risk of gallstones, which is consistent with the present study's findings.14 The authors calculated the BMI of all participants and documented their obesity status. Parra-Landazury et al. mentioned obesity to be one of the important risk factors for cholelithiasis.15 The incidence of nausea/vomiting and STP at 24 hours and 48 hours after surgery was compared between the two groups, and it was found that there was no significant difference between them. Similarly, no significant differences were found between the groups in terms of LOS in the hospital and patient satisfaction. Sanjay et al. documented that the incidence of nausea/vomiting, STP, LOS in the hospital, and analgesia requirement were not affected by the presence or absence of drain placement in uncomplicated LC.16 These results align with the findings of the present study. Shamim conducted a local study in Karachi, Pakistan, and concluded that drains do not offer any benefit in preventing nausea/vomiting and STP in uncompli-cated LC.17 Dhiman et al. discouraged the routine use of subhepatic drain, mentioning that it increases the STP without offering any benefit.18 Nagpal et al. also discouraged the routine placement of drains to reduce nausea/vomiting and STP.19 Vafaei et al. observed that abdominal drain significantly reduces the incidence of STP without increasing the morbidity of patients, which does not align with the results of the present study.20
Findings of the current research, along with those of many other studies already published, support the idea that the routine use of a drain does not offer any benefit in reducing nausea/vomiting and STP in uncomplicated LC. The unjusti-fied use of a drain may be a source of pain, discomfort, increased hospital stay, and a higher risk of surgical site infection. Moreover, patient mobility may also be compromised, leading to delayed recovery. However, drains can be used in cases of difficult LC when a bile leak or oozing is anticipated, keeping in mind that drains may not always perform as intended. They often provide only a false sense of security to the operating surgeon and can sometimes mask ongoing complications. Therefore, a careful clinical judgement and case selection are essential when deciding on drain placement.
Single-centre study, limited follow-up period, and limited sample size were a few limitations of the present study. Variations in the demographic features of the participants could have impacted the outcomes. The correlation between BMI, gender, and age with the post-surgery outcomes was not established. It is possible that the findings do not generalise to different ethnicities and environments.
CONCLUSION
In uncomplicated LCs, subhepatic drains do not offer any benefit to reduce the incidence of nausea/vomiting and STP.
ETHICAL APPROVAL:
The ethical approval was obtained from the Ethical Review Committee of Pak Emirates Military Hospital, Rawalpindi, Pakistan (Serial No: A/28/ERC/44/2025).
PATIENTS’ CONSENT:
Informed consent was taken from all the participants in the study.
COMPETING INTEREST:
The authors declared no conflict of interest.
AUTHORS’ CONTRIBUTION:
MG, MA, WG, MB, SZ, HK: Conception, design of the study, acquisition of the data, article writing, statistical analysis, and proofreading.
All authors approved the final version of the manuscript to be published.
REFERENCES