Open hemorrhoidectomy under local anesthesia versus saddle block in western Uganda: a study protocol for a prospective equivalence randomized, double-blind controlled trial

Abstract

Background While open hemorrhoidectomy under local anesthesia has been shown to be more cost-effective with shorter operation times and lower complication rates, local anesthesia is still not considered as a first-line technique in low-income countries like Uganda. The objective of this trial is to compare open hemorrhoidectomy using local anesthesia versus saddle block among patients with primary uncomplicated 3rd- or 4th-degree hemorrhoids in western Uganda. Methods The protocol for a prospective equivalence randomized, double-blind controlled trial was conducted among patients with primary uncomplicated 3rd- or 4th-degree hemorrhoids. Recruitment was started in December 2021 and is expected to end in May 2022. Consenting participants who require open hemorrhoidectomy indicated at Kampala International Teaching Hospital, Uganda, will be randomized into two groups of 29 patients per arm. Discussion The primary outcome of this study is to compare the occurrences of postoperative pain following open hemorrhoidectomy using the visual analog scale in an interval of 2, 4, and 6 h and 7 days postoperatively. Furthermore, the mean operative time from the induction of anesthesia to the end of the surgical procedure as well as the cost-effectiveness of the 2 techniques will be assessed in both groups. Open hemorrhoidectomy under local anesthesia has the potential to offer benefits to patients but most importantly expediting return to baseline and functional status, shorter hospital stay by meeting the faster discharge criteria, and reduction in costs associated with reduced length of stay and complications. Trial registration Pan African Clinical Trials Registry PACTR202110667430356. Registered on 8 October 2021

Comparison of saddle block and pudendal nerve block by SEPTA technique for anorectal surgeries: A randomized control study

“…Similar findings were observed by Jinjil et al, who observed in their study that perianal block using ropivacaine 0.2% with dexmedetomidine as an adjuvant provides long-lasting postoperative analgesia and is acceptable to the surgeon. 10 Anorectal surgeries such as hemorrhoidectomy under LA have advantage of expediting return to baseline functional status and reduction in costs associated with reduced length of stay and complications similar to findings observed by Sikakulya et al, 21 Like our study, other studies have also reported no case of perianal abscess after LA technique. 20,23 Adverse effects of LA on CNS, CVS, and respiratory system after absorption are not seen in our study since we used less concentration and volume of LA and site of injection was also away from pudendal neurovascular bundle.…”

“…18,19 Some studies have used EMLA cream or 5% lignocaine-based ointment about an hour before injecting LA 10,20,21. Scarfone et al suggested that lower injection rate of LA is associated with less pain because of less rapid distension of local tissue and activation of fewer nerve endings 22.…”

The Administration of Spinal or Local Anesthesia in Anal Fissure and Hemorrhoidectomy: A Comparative Literature Review

“…Moreover, since local anesthesia was given through 0.5% lignocaine and 0.25% bupivacaine, it was seen that bleeding was lesser due to the vasoconstriction effect. The same applied to the rate of complications that were significantly lesser in patients who had undergone local anesthesia for his procedure [19].…”