Okam Princeston C, Ikechebelu Joseph I, Eleje George U, Albert Innocent C, Okpala Boniface C, Okam Chioma F, Nwajiaku Louis A, Joe-Ikechebelu Ngozi N, Ezeigwe Chijioke O, Chigbo Chisom G, Okafor Chigozie G
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria.
Life Specialist Hospital Nnewi and Life International Hospital, Awka, Anambra State, Nigeria.
Eur J Obstet Gynecol Reprod Biol X. 2024 Jul 11;23:100326. doi: 10.1016/j.eurox.2024.100326. eCollection 2024 Sep.
To determine the efficacy and safety of rectal diclofenac for relieving postoperative pain following diagnostic hystero-laparoscopy and dye test (dHLD).
A prospective, double-blind, placebo-controlled, randomized trial was conducted among women who underwent dHLD to evaluate fertility. The women received either rectal diclofenac with intramuscular pentazocine or intramuscular pentazocine with rectal placebo for postoperative analgesia. The median pain scores at different time points were assessed as the primary outcome measures using the Numerical Rating Scale for pain. The secondary outcome measures were analgesic consumption, time at which first analgesic was requested, satisfaction with pain relief and any adverse events.
In total, 108 participants were analysed (54 in each group, 1:1 ratio). The median score for postoperative pain was lower for the diclofenac group compared with the placebo group at 4 h (52.53 vs 56.47; = 0.507), 6 h (50.48 vs 58.52; = 0.174), 8 h (51.42 vs 57.65; = 0.296), 10 h (51.35 vs 57.65; = 0.285) and 12 h (52.45 vs 56.55; = 0.485) post surgery, although the difference was not significant ( > 0.05). Seventeen participants required rescue analgesia with 30 mg of pentazocine: 11 at 4 h post surgery [5 (62.5 %) vs 6 (66.7 %)], three at 6 h post surgery [2 (25.0 %) vs 1 (11.1 %)], two at 8 h post surgery [1 (12.5 %) vs 1 (11.1 %)], and one at 12 h post surgery [0 vs 1 (11.1 %)] for the diclofenac and placebo groups respectively ( = 0.713). There were no significant differences in postoperative adverse effect profiles, overall patient satisfaction, and need for rescue analgesia between the two groups ( > 0.05).
Postoperative use of rectal diclofenac and pentazocine is safe, but did not significantly improve pain scores, patient satisfaction and need for rescue analgesia following dHLD, compared with patients who received pentazocine and placebo. While a multi-modal approach to pain relief following dHLD does not appear to be significantly beneficial, a multi-centre study is needed to confirm or refute these findings.
确定直肠用双氯芬酸缓解诊断性宫腹腔镜检查及输卵管通液术（dHLD）术后疼痛的疗效和安全性。
对接受dHLD以评估生育能力的女性进行了一项前瞻性、双盲、安慰剂对照、随机试验。这些女性接受直肠用双氯芬酸联合肌肉注射喷他佐辛或肌肉注射喷他佐辛联合直肠用安慰剂用于术后镇痛。使用疼痛数字评定量表将不同时间点的中位疼痛评分作为主要结局指标进行评估。次要结局指标为镇痛药消耗量、首次要求使用镇痛药的时间、对疼痛缓解的满意度以及任何不良事件。
总共分析了108名参与者（每组54名，1:1比例）。双氯芬酸组术后疼痛的中位评分在术后4小时（52.53对56.47； = 0.507）、6小时（50.48对58.52； = 0.174）、8小时（51.42对57.65； = 0.296）、10小时（51.35对57.65； = 0.285）和12小时（52.45对56.55； = 0.485）时低于安慰剂组，尽管差异不显著（ > 0.05）。17名参与者需要用30毫克喷他佐辛进行补救镇痛：双氯芬酸组和安慰剂组分别有11名在术后4小时[5名（62.5%）对6名（66.7%）]、3名在术后6小时[2名（25.0%）对1名（11.1%）]、2名在术后8小时[1名（12.5%）对1名（11.1%）]和1名在术后12小时[0名对1名（11.1%）]（ = 0.713）。两组之间在术后不良反应情况、总体患者满意度和补救镇痛需求方面无显著差异（ > 0.05）。
与接受喷他佐辛和安慰剂的患者相比，术后使用直肠用双氯芬酸和喷他佐辛是安全的，但在dHLD术后并未显著改善疼痛评分、患者满意度和补救镇痛需求。虽然dHLD术后采用多模式镇痛方法似乎没有显著益处，但需要进行多中心研究来证实或反驳这些发现。
