DOI: https://doi.org/10.21203/rs.3.rs-1611685/v1
Background: Endoscopic minimally treatment of internal hemorrhoids may cause postoperative pain. The aim of the study is to investigate the analgesic effect of lidocaine plus lauromacrogol on postoperative pain caused by endoscopic rubber band ligation (ERBL) combined with injection sclerotherapy (IS) for internal hemorrhoids treatment.
Methods: Clinical data of Grade Ⅲ internal hemorrhoids patients who underwent ERBL combined with IS in department of digestive medicine of Shenzhen Hospital, Southern Medical University, were retrospectively analyzed. According to the composition of sclerosing solution, the patients were divided into control group (lauromacrogol group, 46 patients) and study group (lidocaine plus lauromacrogol group, 20 patients). Postoperative pain (quantized by Visual Analogue Scale, VAS), pain relief time and postoperative adverse reactions were compared. The therapeutic effect was followed up 1 month after operation.
Results: VAS of postoperative pain was 0.80±0.42 points and pain relief time was 0.90±0.56 days in the study group, while VAS of postoperative pain was 1.63±0.79 points and pain relief time was 1.69±0.73 days in the control group (P<0.05), there was statistical difference between them (P<0.05). There was no significant difference in the incidence of postoperative adverse reactions and follow-up therapeutic effect between the control group and the study group.
Conclusion: Lidocaine plus lauromacrogol is useful for pain alleviation on ERBL combined with IS for internal hemorrhoids treatment because of its convenient procedure, low adverse reaction incidence and good therapeutic effect, which is worthy of promotion.
Internal hemorrhoid is a soft vein group formed by the expanded varicose and hyperemia of the vein cluster under the mucous membrane at the end of the rectum above the dentate line of the anus[1]. The main symptoms are bleeding, prolapse, mucus soiling and itching[2]. According to Goligher 's classification[3], internal hemorrhoids with different degrees of prolapse can be divided into 4 degrees, and the treatment is also different accordingly. With the great progress of clinical techniques and development of minimally invasive treatment, more and more endoscopists have begun to use endoscopy for minimally invasive treatment of internal hemorrhoids. Preliminary clinical studies show that endoscopic minimally invasive treatment has the advantages of flexible operation, less pain, shorter recovery phase, less complication and less cost for patients[4, 5]. Among them, injection sclerotherapy (IS) is the main treatment for I-Ⅲ degree hemorrhoids with bleeding[6], while endoscopic rubber band ligation (ERBL) is the main treatment for II-Ⅲ degree hemorrhoids with prolapse[7]. Recent studies have shown that ERBL and IS performed simultaneously has a better effect on alleviating symptoms and signs of Grade Ⅱ and Ⅲ internal hemorrhoids with prolapse and bleeding, and the incidence of postoperative bleeding, anal swelling and urinary retention is lower than that of ERBL alone[8]. However, we found in clinical practice that there is still a certain proportion of postoperative pain, and local injection of lidocaine during operation can relieve postoperative pain. To verify the effectiveness of this technique, we retrospectively studied 66 patients with internal hemorrhoids treated by ERBL combined with IS in the Department of Gastroenterology, Shenzhen Hospital of Southern Medical University, and compared the analgesic effect of lidocaine on postoperative pain.
A retrospective analysis was performed on the patients with internal hemorrhoids treated by ERBL combined with IS in Department of Gastroenterology, Shenzhen Hospital of Southern Medical University from February 2019 to December 2021. The grading of hemorrhoids was performed according to Goligher’ s classification[3]. All the patients included in the analysis were diagnosed with Grade Ⅲ internal hemorrhoids with bleeding and prolapsing. According to the different components of sclerosing solution, the patients were divided into control group and study group. The control group using lauromacrogol alone was consisted of 46 patients, including 28 males and 18 females, with an average age of 45.5 ± 10.52 years old. The study group using a mixture of lauromacrogol + 2% lidocaine on a scale of 4:1, was consisted of 20 cases, including 12 males and 8 females, with an average age of 43.2 ± 11.37 years old. There was no statistically significant difference in gender and age between the two groups (Table 1).
| Sex (n, %) | Age (years) | ||
|---|---|---|---|
| Male | Female | ||
| Control group | 28 (60.87%) | 18 (39.13%) | 45.5 ± 10.52 |
| Study group | 12 (60%) | 8 (40%) | 43.2 ± 11.37 |
| t value | -0.065 | 0.779 | |
| P value | 0.948* | 0.439* | |
| *t-test | |||
All patients received bowel preparation with 3.0L solution of polyethylene glycol electrolytes powder before surgery. After 4–6 hours of fasting and water deprivation, the operation was performed under intravenous anesthesia. First, the whole colorectum examination was performed to exclude other diseases leading to hematochezia, such as tumor, inflammatory bowel disease, etc., then internal hemorrhoids were treated.
ERBL was performed after the ligating device (Speedband, Boston Scientific Co., Ltd, USA) was installed with endoscope (Fuji Film Co., Ltd, Japan), the rubber band was released after hemorrhoids were suctioned into the cap with the tip of the endoscope when the endoscope was in a retroflexed position. Repeat the above steps until the prolapsed hemorrhoids relieve, and the total ligations were no more than 7.
IS was performed after ERBL. Under direct vision of endoscope, lauromacrogol (control group) or mixture of lauromacrogol and lidocaine (study group) was injected into 2–3 submucosal sites at the base of hemorrhoids, between 2 elastic bands with sterile disposable injection needle (4mm, 23G, Interject, Boston Scientific Co., Ltd, USA), 0.5ml at each point, and the total dose was no more than 10ml. (Fig. 1, Supplementary material)
The primary outcome measure of the study was patients’ postoperative pain degree. Visual Analogue Scale (VAS) was used to evaluate postoperative pain. A horizontal line of 10cm was drawn, with one end of the horizontal line being 0, indicating no pain and the other end being 10, indicating severe pain. Duration of pain relief was also recorded. Questionnaire was used to evaluate postoperative adverse reactions, including bleeding, anal swelling and urine retention as secondary outcome measures.
Patients were followed up 1 month after surgery to evaluate the efficacy. Cure indicating hematochezia, prolapse symptoms disappear completely; Relief indicating hematochezia and prolapse symptoms were significantly reduced; Invalid indicating hematochezia and prolapse symptoms are not alleviated or even aggravated.
SPSS v26.0 (IBM Co., Ltd, USA) was used for statistical analysis. Measurement data were represented by mean ± SE and t-test was used for comparison; Enumeration data were summarized by frequency and percentage (n [%]), and Fisher's exact test was used for comparison. Rank data were summarized by frequency and percentage (n [%]), Wilcoxon rank sum test was used for comparison. P < 0.05 was considered statistically significant.
The postoperative VAS score was 1.63 ± 0.79 and the pain relief time was 1.69 ± 0.73 days in the control group, while the postoperative VAS score was 0.80 ± 0.42 and the pain relief time was 0.90 ± 0.56 days in the study group, both were lower than the control group and statistically significant (P < 0.05) (Fig. 2, Table 2).
| VAS score | Pain relief time (days) | |
|---|---|---|
| Control group | 1.63 ± 0.79 | 1.69 ± 0.73 |
| Study group | 0.80 ± 0.42 | 0.90 ± 0.56 |
| t value | 5.562 | 4.866 |
| P value* | 0.000* | 0.000* |
| *t-test | ||
The control group comparing with the study group, postoperative bleeding less than 5ml was 44 cases (95.65%) versus 18 cases (90%), 5-10ml was 2 cases (4.35%) versus 2 cases (10%); No postoperative anal swelling was 35 cases (76.09%) versus 14 cases (70%), swelling covers 1/4 perianal region was 11 cases (23.91%) versus 6 cases (30%); No postoperative urine retention was 43 cases (93.48%) versus 18 cases (90%), postoperative urination difficulty was 3 cases (6.52%) versus 2 cases (10%). There was no statistically difference between two groups (Table 3).
| Adverse reactions | Options | Groups | P value | |
|---|---|---|---|---|
| Control group | Study group | |||
| The amount of postoperative bleeding | A. Less than 5 ml B. 5–10 ml C.10–20 ml D. More than 20 ml | 44(95.65%) 2(4.35%) 0(0%) 0(0%) | 18(90%) 2(10%) 0(0%) 0(0%) | 0.452# |
| Postoperative urination | A. No urination disorder. B. Have difficulty when urination. C. Urinary retention. | 43(93.48%) 3(6.52%) 0(0%) | 18(90%) 2(10%) 0(0%) | 0.556# |
| Anal swelling | A. No swelling. | 35(76.09%) | 14(70%) | 0.482# |
| B. Swelling affected 1/4 of perianal area. | 11(23.91%) | 6(30%) | ||
| C. Swelling affected 1/2 of perianal area. | 0(0%) | 0(0%) | ||
| D. Swelling affected the whole perianal area. | 0(0%) | 0(0%) | ||
| #Fisher exact test | ||||
The control group comparing with the study group, cure was 35 cases (76.09%) versus 12 cases (60.00%), relief was 11 cases (23.91%) versus 8 cases (40.00%) and there was no invalid case in both groups. There was no statistically difference between two groups (Table 4).
| Group | Therapeutic Effect | Z value | P value | ||
| Cure | Relief | Invalid | |||
| Control group | 35 (76.09%) | 11 (23.91%) | 0 (0%) | -1.316 | 0.188& |
| Study group | 12 (60.00%) | 8 (40.00%) | 0 (0%) | ||
| &Wilcoxon rank sum test | |||||
Symptomatic hemorrhoids are common disease, characterized by bleeding, prolapse, pain, anal itching, swelling, and mucus soiling. The incidence of hemorrhoids ranges from 4–38.9% in different regions of the world[9, 10]. Hemorrhoids are believed to result from the weakening of the anal cushion and spasm of the internal sphincter[2]. It is the higher anal resting pressure which leads to internal anal sphincter spasms and anal cushion congestion, finally results in prolapsing and bleeding[11, 12]. ERBL can block the blood supply of the hemorrhoid mucosa, resulting in ischemia necrosis, ulceration and then fibrosis, which can lift up the anal cushion and effectively relieve prolapse symptoms[13]. IS results in aseptic inflammatory reaction, and leads to secondary tissue fibrosis and reduction of hemorrhoid blood flow[14].
The combination of ERBL and IS not only merges the advantages of both the techniques, but also decreases their complications[15]. At present, most researchers suggest that ERBL should be performed at 0.5-1.0cm above the dentate line[16, 17]. However, there is a high risk of accidental injury to the dentate line leading to severe postoperative pain. We found in daily clinical practice that ligating above the anorectal line in a retroflexed position can effectively reduce the incidence of postoperative pain. For hemorrhoids with prolapsing and bleeding, compared with ERBL alone, combination of ERBL and IS has the advantages of less postoperative pain and bleeding, and equivalent efficiency[15, 18].
This research retrospectively studied the patients who received combined treatment of internal hemorrhoids in our center. It was found that the VAS score of postoperative pain in patients who received combined treatment was still up to 1.63 ± 0.79 points and the duration of pain relief was 1.69 ± 0.73 days when lauromacrogol was used alone during sclerotherapy. Therefore, postoperative analgesia should be mainly based on quick and short effects. Previous studies have shown that local subcutaneous injection of 0.5% lidocaine can effectively and rapidly reduce pain degree after anorectal surgery, with high safety, and can greatly shorten the hospital stay of patients and improve their satisfaction[19]. Lidocaine is a short and fast-acting anesthetic which is safe for local subcutaneous injection[20]. The mixture of lidocaine and lauromacrogol has been reported to be used in sclerotherapy of telangiectasias and reticular veins[21]. The degree of postoperative pain was significantly reduced, and the incidence of systemic or local adverse reactions was low, suggesting that the combination of these two drugs can be used for local injection with high safety, but there is still no relevant research about its application on endoscopic treatment of internal hemorrhoids. Based on previous clinical practice, our center applied the mixture of lauromacrogol and 2% lidocaine to internal hemorrhoids sclerotherapy. It is showed that the final concentration of lidocaine at 0.4% could achieve good analgesic effect, and the postoperative pain VAS score could be as low as 0.80 ± 0.42 points. The duration of pain relief was shortened to 0.90 ± 0.56 days, which was significantly lower than that of using lauromacrogol alone. No systemic adverse reactions occurred, and the follow-up treatment effect and incidence of local adverse reactions were similar to that of lauromacrogol alone.
In addition, in order to avoid the contamination of the puncture site by the remaining feces in the intestine and cause operation associated infection, the mucosa of anal canal should be fully rinsed pure water to keep the mucosa clean. Disposable sterile injection needle was used during operation to reduce the risk of infection.
For the treatment of patients with prolapse and bleeding hemorrhoids, ERBL combined with IS is effective and safe, but there is still a certain incidence of postoperative pain. We found that using the mixture of lauromacrogol and lidocaine for IS is effective for local analgesia during and after operation, which can obviously relieve postoperative pain and is worthy of clinical promotion.
endoscopic rubber band ligation
injection sclerotherapy
Visual Analogue Scale.
Ethical approval
This retrospective study was one of research themes under center research grant titled “Endoscopic minimally invasive treatment of internal hemorrhoids” which has been approved by the Medical Ethics Committee of Shenzhen Hospital of Southern Medical University in 2021 (Document No. AF/SC-06/01.0). Due to the retrospective nature of the data analysis, the requirement for informed consent from the patients was waived.
Consent for publication
Not Applicable.
Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Competing interests
The authors declare that they have no competing interests.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Author Contributions
WX drafted the work. GLX collected the data. LD analyzed the data. YZ made substantial contributions to the conception. All authors read and approved the final manuscript.
Acknowledgement
Not applicable.