Chien-Yuh Yeh1, Shu-Wen Jao, Jinn-Shiun Chen, Chung-Wei Fan, Hong-Hwa Chen, Pao-Shiu Hsieh, Chang-Chieh Wu, Chia-Cheng Lee, Yi-Hung Kuo, Meng-Chiao Hsieh, Wen-Shih Huang, Yuan-Chiang Chung, Tian-Yuh Liou, Hsi-Hsiung Chiu, Wen-Ko Tseng, Ko-Chao Lee, Jeng-Yi Wang. 1. *Department of Surgery, Division of Colon and Rectal Surgery, Chang Gung Memorial Hospital at Linkou †Chang Gung University College of Medicine, Taoyuan ‡Department of Surgery, Division of Colon and Rectal Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei §Division of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Keelung ∥Division of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Kaohsiung ¶Division of Colon and Rectal Surgery, Chang Gung Memorial Hospital, Chiayi #Department of Surgery **Division of Colon and Rectal Surgery, Cheng Ching General Hospital, Chung Kang Branch, Taichung, Taiwan.
Abstract
OBJECTIVES: This study was conducted to evaluate the safety and efficacy of single sebacoyl dinalbuphine ester (SDE) injection (150 mg/2 mL) when administered intramuscularly to patients who underwent hemorrhoidectomy for postoperative long-acting analgesia. METHODS: A total of 221 patients scheduled for hemorrhoidectomy from 6 centers in Taiwan were randomly divided into SDE group and placebo group, and received the treatment, vehicle or SDE, 1 day before the surgery. Visual analogue scale (VAS) was recorded up to 7 to 10 days. Pain intensity using VAS AUC through 48 hours after surgery was calculated as the primary efficacy endpoint. RESULTS: Area under the curve of VAS pain intensity scores (VAS AUC) through 48 hours after hemorrhoidectomy was significantly less in SDE group than those in placebo group (209.93 vs. 253.53). VAS AUC from the end of surgical procedure to day 7 was also significantly different between SDE and placebo group (630.79 vs. 749.94). SDE group consumed significantly less amount of other analgesics, such as PCA ketorolac and oral ketorolac. Median time from the end of surgery to the first use of pain relief medication was also shortened in the placebo group than in the SDE group. Most adverse events were assessed as mild and tolerable in both groups. DISCUSSION: SDE injection demonstrated an extended analgesia effect, with a statistically significant reduction in pain intensity through 48 hours and 7 days after hemorrhoidectomy.
RCT Entities:
OBJECTIVES: This study was conducted to evaluate the safety and efficacy of single sebacoyl dinalbuphine ester (SDE) injection (150 mg/2 mL) when administered intramuscularly to patients who underwent hemorrhoidectomy for postoperative long-acting analgesia. METHODS: A total of 221 patients scheduled for hemorrhoidectomy from 6 centers in Taiwan were randomly divided into SDE group and placebo group, and received the treatment, vehicle or SDE, 1 day before the surgery. Visual analogue scale (VAS) was recorded up to 7 to 10 days. Pain intensity using VAS AUC through 48 hours after surgery was calculated as the primary efficacy endpoint. RESULTS: Area under the curve of VAS pain intensity scores (VAS AUC) through 48 hours after hemorrhoidectomy was significantly less in SDE group than those in placebo group (209.93 vs. 253.53). VAS AUC from the end of surgical procedure to day 7 was also significantly different between SDE and placebo group (630.79 vs. 749.94). SDE group consumed significantly less amount of other analgesics, such as PCA ketorolac and oral ketorolac. Median time from the end of surgery to the first use of pain relief medication was also shortened in the placebo group than in the SDE group. Most adverse events were assessed as mild and tolerable in both groups. DISCUSSION: SDE injection demonstrated an extended analgesia effect, with a statistically significant reduction in pain intensity through 48 hours and 7 days after hemorrhoidectomy.