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.

Euthyroidectomy under local versus general anesthesia in health camp settings in Uganda: a protocol for randomized prospective equivalence single-blind controlled trial.

BACKGROUND: Endemic goiter is highly prevalent in Uganda at 60.2%, contributing to the high surgical burden. While compelling evidence suggest that in selected cases, thyroidectomy under local anesthesia (LA) is associated with fewer post-operative complications, low costs, and short hospital stays, local anesthesia is not considered a priority technique for thyroidectomy in resource-constrained settings such as Uganda, despite having fewer general anesthesia (GA) and critical care providers. The objective of this trial is to compare euthyroidectomy under local versus general anesthesia among patients with grade 1-2 uncomplicated euthyroid goiter in Uganda. METHODS: This prospective equivalence randomized, single-blind controlled trial protocol will be conducted among eligible participants with grade 1-2 uncomplicated euthyroid goiters. The recruitment processes will start in October 2022 and end in April 2023. Consenting participants with an indication for thyroidectomy will be randomized into two arms of 29 participants in each arm during the Bulamu Health Care Organization surgical camps in Uganda. DISCUSSION: The primary outcome of this trial protocol is to compare the early post-operative complications of euthyroidectomy done under LA versus GA. The outcome variables include post-operative pain based on visual analogue scale, nausea, vomiting, hematoma formation, and transient voice changes determined at an interval of 6, 12, and 24 h and at 30 days. In addition, we shall compare the surgical site infection rates, procedure costs, hospital stay, and patients' level of satisfaction based on a 5-point Likert scale and their willingness to undergo a similar surgery using the same anesthetic technique between the two groups. We hypothesize that euthyroidectomy under LA could potentially offer similar benefits as GA, reduce costs related to procedure, complications, and hospital stay while at the same time mitigating the unmet need for surgery attributable to shortage of general anesthesia providers and critical care facilities in low-income settings. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR202208635457430. Registered on 11th August 2022. All items from the WHO trial registration data set are within the protocol. Version number and date: version 3, 15/03/2023.

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.