Local anesthesia versus saddle block for open hemorrhoidectomy: cost-analysis from a randomized, double blind controlled trial.

BACKGROUND: Despite the benefits attributed to the use of local anesthesia (LA) for open hemorrhoidectomy (OH) in developed countries, this technique is still not considered as the first line technique in low-income countries such as Uganda; therefore, we aimed at comparing the cost of OH under LA versus Saddle block among patients with 3rd or 4th degree hemorrhoids. METHODS: This trial was conducted from December 2021 to May 2022 among patients with primary uncomplicated 3rd or 4th degree hemorrhoids. The operating time, and direct costs in (US$) including medical and non-medical were recorded. We analysed the cost in the two groups (local anesthesia versus saddle block) using SPSS version 23.0. RESULTS: Findings of fifty-eight patients were analysed including 29 participants per group. There was a significant difference in operating time and cost among the two groups (p < 0.05). The mean operating time was 15.52 ± 5.34(SD) minutes versus 33.72 ± 11.54 min for OH under LA and SB respectively. The mean cost of OH under LA was 57.42 ± 8.90 US$ compared to 63.38 ± 12.77US$ in SB group. CONCLUSION: The use of local anesthesia for OH was found to have less operating time with high-cost effectiveness. Being affordable, local anesthesia can help to increase the turnover of patients who would otherwise wait for the availability of anesthesia provider. Policy makers should emphasize its applicability in low-income settings to help in the achievement of 2030 global surgery goals. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR202110667430356. Registered on 08/10/2021.

Pain assessment following open hemorrhoidectomy under local anesthesia versus saddle block: a multicenter randomized controlled trial.

BACKGROUND: There is disparity in evidence on pain assessment post open hemorrhoidectomy (OH) using local anesthesia and its use in developing countries compared to developed countries. Therefore, we conducted this study to assess the occurrence of postoperative pain following open hemorrhoidectomy under local anesthesia versus saddle block for uncomplicated 3rd or 4th degree hemorrhoids. METHODS: This was a prospective equivalence randomized, double blind controlled trial conducted from December 2021 to May 2022 among patients with primary uncomplicated 3rd or 4th degree hemorrhoids. Pain severity was assessed at 2, 4 and 6 h post open hemorrhoidectomy using visual analogue scale (VAS). Data was analysed using SPSS version 26 at a p < 0.05 as statically significant using visual analogue scale (VAS). RESULTS: We recruited 58 participants in this study who underwent open hemorrhoidectomy under local anesthesia or saddle block (29 participants per group). The sex ratio was of 1.15 of female to male and a mean age of 39 ± 13. VAS was found to be different at 2 h post OH compare to other time of pain assessment but not statically significant by area under the cover (AUC) (95% CI = 486-0.773: AUC = 0.63; p = 0.09) with a none significance by Kruskal-Wallis's test (p:0.925). CONCLUSION: Local anesthesia was found to be having a similar pain severity occurrence in post operative period among patients undergoing open hemorrhoidectomy for primary uncomplicated 3rd or 4th degree hemorrhoids. Close monitoring of pain in postoperative period is mandatory especially at 2 h to assess need of analgesia. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR202110667430356. Registered on 8th October, 2021.

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

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.