Department of Anaesthesia and Intensive Care Obafemi Awolowo University Ile-Ife Nigeria.
Department of Anaesthesia and Intensive Care Obafemi Awolowo University Teaching Hospitals Complex Ile-Ife Nigeria.
BJS Open. 2019 Mar 26;3(4):453-460. doi: 10.1002/bjs5.50159. eCollection 2019 Aug.
Short-term pain relief can be achieved by local anaesthetic infiltration of port sites at the end of laparoscopic surgery. This study aimed to assess feasibility of performing an RCT to evaluate short-term postoperative analgesia after laparoscopic surgery in Nigeria using two local anaesthetics for port-site infiltration saline placebo.
This was a placebo-controlled, patient- and outcome assessor-blinded, external feasibility RCT. Patients undergoing elective laparoscopic cholecystectomy for symptomatic ultrasound-proven gallstones were randomized into three groups: lidocaine with adrenaline (epinephrine), bupivacaine or saline control. The feasibility of recruitment, compliance with randomized treatment allocation, and completion of pain and nausea outcome measures were evaluated. Pain was assessed at 2, 6, 12 and 24 h after surgery using a 0-10-point numerical rating scale (NRS) and a four-point verbal rating scale. Nausea was assessed using NRS at the same time points. Clinical outcomes were assessed only in patients who received the correct randomized treatment allocation.
Of 79 patients screened for eligibility, 69 were consented and randomized (23 per group). Overall, compliance with randomized treatment allocation was achieved in 64 patients (93 per cent). All pain and nausea assessments were completed in these 64 patients. On the NRS, most patients had moderate to severe pain at 2 h (39 of 64, 61 per cent), which gradually reduced. Only six patients (9 per cent) had moderate to severe pain at 24 h.
Recruitment, compliance with the randomized allocation, and completion of pain outcome measures were satisfactory. This study demonstrates the feasibility of conducting a surgical RCT in a resource-limited setting. Registration number: ISRCTN 17667918 (https://www.isrctn.com).
腹腔镜手术结束时，在端口部位局部麻醉浸润可以实现短期疼痛缓解。本研究旨在评估在尼日利亚使用两种局部麻醉剂（利多卡因加肾上腺素、布比卡因）对端口部位进行浸润，以生理盐水作为安慰剂，对腹腔镜手术后短期术后镇痛进行随机对照试验（RCT）的可行性，评估生理盐水作为安慰剂对腹腔镜手术后短期术后镇痛的可行性。
这是一项安慰剂对照、患者和结果评估者双盲、外部可行性 RCT。纳入行择期腹腔镜胆囊切除术的症状性超声证实胆囊结石患者，随机分为三组：利多卡因加肾上腺素（肾上腺素）、布比卡因或生理盐水对照组。评估招募的可行性、对随机治疗分配的依从性以及疼痛和恶心结局测量的完成情况。使用 0-10 点数字评分量表（NRS）和 4 点口述评分量表在手术后 2、6、12 和 24 小时评估疼痛，使用 NRS 在相同时间点评估恶心。仅评估接受正确随机治疗分配的患者的临床结局。
在 79 名符合条件的患者中，有 69 名同意并随机分组（每组 23 名）。总体而言，64 名患者（93%）实现了对随机治疗分配的依从性。所有疼痛和恶心评估均在这 64 名患者中完成。在 NRS 上，大多数患者在 2 小时时疼痛为中度至重度（64 名患者中的 39 名，61%），疼痛逐渐减轻。仅 6 名患者（9%）在 24 小时时仍有中度至重度疼痛。
招募、对随机分组的依从性以及疼痛结局测量的完成情况令人满意。本研究证明了在资源有限的环境中进行外科 RCT 的可行性。注册号：ISRCTN 17667918（https://www.isrctn.com）。
