Thakur Sunil, Sharma Anupriya, Kaushal Sushruti, Sharma Ashish, Sharma Nisha, Thakur Preyander S
Departments of Anesthesia, Dr. Radhakrishnan Govt. Medical College, Hamirpur, Himachal Pradesh, India.
Departments of Dentistry, Dr. Radhakrishnan Govt. Medical College, Hamirpur, Himachal Pradesh, India.
J Pharm Bioallied Sci. 2023 Jul;15(Suppl 1):S299-S302. doi: 10.4103/jpbs.jpbs_474_22. Epub 2023 Jul 5.
Transversus abdominis plane (TAP) block is a technique of regional anesthesia, introduced by Rafi in 2001. Various additives have been added to prolong the duration of effect of TAP block. We conducted this study to see if addition of clonidine to bupivacaine significantly increases the duration of effect of TAP block.
This randomized, parallel group, placebo controlled double blind clinical trial was conducted on 100 healthy participants (ASAII) undergoing LSCS under Spinal anesthesia (SA) from Jan 2021 to July 2021 after consent of Institutional Ethics Committee. Women with contraindications to spinal anesthesia, allergy to any of the drugs or not-suitable for cesarean under SA were excluded. After written informed consent, eligible participants were randomly allocated into two groups using computer generated random number tables using serially numbered opaque sealed envelopes. 48 out of 50 participants in group A (Bupivacaine) were given TAP block with 20 ml of 0.25% bupivacaine bilaterally. 2 women were excluded because of conversion to General Anesthesia. Similarly, 47 out of 50 participants in Group B (Bupivacaine + Clonidine) were given TAP block with 20 ml of 0.25% bupivacaine plus 1.0 mcg/kg clonidine bilaterally after completion of surgery using 18 G Tuohy needle. Separate person used to fill the drugs for block. Participants were assessed for duration of analgesic effect of TAP block measured as the time to request for additional analgesia. Additional analgesic requirement was noted. Participants were assessed for side effects of clonidine like hypotension, bradycardia, sedation and dryness of mouth. Overall patient satisfaction was also noted. Data was analysed using Graphpad Prism 9, using Student's -test for primary outcome and Mann-Whitney test for secondary outcomes.
The mean 'duration of analgesic effect with TAP block' was 6.34 (SD1.26) hrs for 'Bupivacaine' group and 10.56 (SD2.12) hrs for 'Bupivacaine + Clonidine' group. None of the patients developed hypotension or bradycardia. 25% participants in Bupivacaine only group and 40.42% in Bupivacaine + Clonidine group were sedated ( < 0.05). 20.8% in 'Bupivacaine' group and 51.06% in 'Bupivacaine + Clonidine' group had dryness of mouth ( < 0.001). Patient satisfaction was equal in both the groups.
Addition of clonidine to bupivacaine in the dose of 1 mcg/kg significantly increases the duration of analgesic effect of TAP block, decreases analgesic usage without significant increase in side effects.
腹横肌平面（TAP）阻滞是一种区域麻醉技术，由拉菲于2001年提出。已添加了各种添加剂以延长TAP阻滞的作用持续时间。我们进行这项研究是为了观察在布比卡因中添加可乐定是否能显著延长TAP阻滞的作用持续时间。
这项随机、平行组、安慰剂对照双盲临床试验于2021年1月至2021年7月在100名接受脊髓麻醉（SA）下进行低位剖宫产术的健康参与者（ASAII级）中开展，研究经机构伦理委员会批准。排除有脊髓麻醉禁忌证、对任何药物过敏或不适合在SA下进行剖宫产的女性。在获得书面知情同意后，使用计算机生成的随机数字表和连续编号的不透明密封信封，将符合条件的参与者随机分为两组。A组（布比卡因）的50名参与者中有48名双侧接受了20毫升0.25%布比卡因的TAP阻滞。2名女性因转为全身麻醉而被排除。同样，B组（布比卡因+可乐定）的50名参与者中有47名在手术结束后使用18G Tuohy针双侧接受了20毫升0.25%布比卡因加1.0微克/千克可乐定的TAP阻滞。由不同人员负责配制阻滞用药。评估参与者TAP阻滞的镇痛效果持续时间，以要求追加镇痛的时间来衡量。记录追加镇痛的需求。评估参与者可乐定的副作用，如低血压、心动过缓、镇静和口干。还记录了总体患者满意度。使用Graphpad Prism 9软件进行数据分析，对主要结局采用学生t检验，对次要结局采用曼-惠特尼检验。
“布比卡因”组TAP阻滞的平均“镇痛效果持续时间”为6.34（标准差1.26）小时，“布比卡因+可乐定”组为10.56（标准差2.12）小时。没有患者出现低血压或心动过缓。仅布比卡因组25%的参与者和布比卡因+可乐定组40.42%的参与者出现镇静（P<0.05）。“布比卡因”组20.8%的参与者和“布比卡因+可乐定”组51.06%的参与者出现口干（P<0.001）。两组患者满意度相同。
在布比卡因中添加1微克/千克剂量的可乐定可显著延长TAP阻滞的镇痛效果持续时间，减少镇痛药物使用，且副作用无显著增加。
