Effect of Gargle Containing Honeysuckle and Semen Oroxyli

Pain Clinical Trial

Official title:

The Application of Gargle Containing Honeysuckle and Semen Oroxyli to Reduce the Pain and Complications After Uvulopalatopharyngoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535179
• Other study ID #: HubeiHTCM 001
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: September 2022
• Source: Hubei Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgery All patients included in this study underwent UPPP under general anesthesia with a low-temperature plasma ablation apparatus (PLA-600; Zhongyuan Medical Equipment Co., Ltd.; Shandong, China). Briefly, the surgery was carried out under general anesthesia using a nasal cannula. A 70# low-temperature plasma cutter head was used to perform bilateral epicapsular ablation of the tonsils. Inverted "U" incisions were made on the bilateral soft palate respectively, and the 70# cutter head progressively melted the adipose tissue and other soft tissues in the the veli palatine region. Subsequently, a 55# low-temperature plasma cutter head was used to perform perforation and ablation from between the two mucosal layers of the soft palate to the direction of the hard palate, with 2-3 holes on each side, and each ablation time was 8-12 s.

Treatments Patients in both the 2 groups received amoxicillin sodium suspension every 8 hours for 7 days after UPPP. Except for these drugs, patients in the treatment group were instructed to gargle the suspension solution containing honeysuckle and semen oroxyli (25 mL) for 5 minutes. The solution was given 4 times a day for 2 weeks. The patients in the control group were instructed to gargle normal saline (25 mL) at the same schedule. No NSAIDs were administered unless requested by the patient.

Data collection The post-operative resting throat pain and swallowing throat pain were evaluated at 0 week (12 hours after surgery), 1 week and 2 weeks after UPPP by the patients themselves using a visual analog scale (VAS) based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. Then, the changes of scores from week 0 to week 2 between the 2 groups were compared. The VAS scores related to patient comfort level were also evaluated by patients themselves, with 0 representing very much worse and 10 very much comfort. Furthermore, the researchers who were blinded to the therapeutic regimens evaluated the improvement in postoperative pain of patients within the 2-week postoperative period based on the clinical global impression of improvement (CGI-I score) questionnaire. In this questionnaire, the researchers used a seven-point scale from 1 (very much improved) to 7 (very much worse) to rate the improvement of body pain of the patients (10).

The post-operative complications, such as wound infection and wound bleeding, were collected and analyzed. The baseline characteristics of the patients in 2 groups including age, gender, body mass index (BMI), OSA severity, American Society of Anesthesiologist (ASA) classification and pre-operative complications were also collected. The venous blood was collected at 12 h and 1 week after operation to detect the levels of hs-CRP, hemoglobin, neutrophil% and white blood cell count (WBC).

Statistical analysis The data in this study were analyzed by the SPSS software (version 22.0). Normal distribution quantitative data were described as mean ± SD. The difference between groups were compared by the Student's t test. Non-normal distribution quantitative data were described as median with range and compared with Mann-Whitney U test. Categorical data were described as numbers and percentages and compared using the Chi-square test or Fisher's exact test. P < 0.05 was considered as statistical significance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients who had undergone elective UPPP during the period of April 2019 to January 2022

Exclusion Criteria:

• patients with a history of systemic diseases such as severe cardiac and/or pulmonary disorders;

• patients who were unable to cooperate with evaluations;

• patients with severe diabetes;

• patients who had underwent other surgeries in the last 6 months.

Related Conditions & MeSH terms

• Complication
• Obstructive Sleep Apnea
• Pain
• Sleep Apnea, Obstructive

Intervention

Drug:
• honeysuckle and semen oroxyli solution
The patients in the treatment group were instructed to gargle the solution containing honeysuckle and semen oroxyli (25 mL) four times a day for 2 weeks.

Locations

Country	Name	City	State
China	Hebei Hospital of traditional Chinese Medicine	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of resting throat pain in two groups	For resting throat pain at 1 week and 2 weeks after UPPP, the VAS scores of the treatment group were much lower than those of the control group (P = 0.033 and P = 0.031, respectively, Table 2). However, the VAS scores for resting throat pain measured at 12 h after UPPP were not significantly different between the 2 groups (P = 0.465).	1 week and 2 weeks after UPPP
Primary	Comparison of swallowing throat pain in two groups	For swallowing throat pain, treatment group had much lower VAS scores than control group at 2 weeks after surgery (P < 0.001). But the 2 groups had similar VAS scores for swallowing throat pain at 12 h and 1 week after surgery (P = 0.414 and 0.732, respectively)	12 h, 1 week and 2 weeks after surgery
Primary	Comparison of changes in VAS scores between the two groupd for both resting and swallowing throat pain	The changes of VAS scores for both resting and swallowing throat pain from week 0 to week 2 were significantly higher in treatment group than in control group (P < 0.001 and P = 0.005, respectively).	week 0 to week 2
Primary	Comparison of GGI-I score in two groups	The treatment group performed a lower GGI-I score than control group (P < 0.001)	week 0 to week 2
Primary	Comparison of total complication rates in two groups	No deaths occurred within the 2-week postoperative period. The total complication rates between the 2 groups was not significantly different (P = 0.071)	2 weeks after surgery
Primary	Comparison of post-operative wound infection or wound bleeding between two groups	Although the treatment group had less numbers of patients with post-operative wound infection or wound bleeding, the difference between the 2 groups was not statistically significant.	2 weeks after surgery
Primary	Comprision of the levels of hs-CRP, hemoglobin, neutrophil% and WBC between the 2 groups	The levels of hs-CRP, hemoglobin, neutrophil% and WBC between the 2 groups at 12 h after surgery were not significantly different. One week after operation, the levels of hs-CRP, Hemoglobin, and WBC in the treatment group were significantly lower than those in the control group (P<0.05).	12 h after surgery and 1 week after sugery