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.

Outcome Measurement at a Ugandan Referral Hospital: Validation of the Mbarara Surgical Services Quality Assurance Database.

BACKGROUND: Five billion people lack access to surgery. Accurate and complete data have been identified as essential to the global scale-up of perioperative care. This study retrospectively validates the Mbarara Surgical Services Quality Assurance Database (SQUAD), an electronic outcomes database at a Ugandan secondary referral hospital. METHODS: SQUAD data were compared to paper records from August 2013 to January 2017. To assess data entry accuracy, two researchers independently extracted 24 patient variables from 170 charts. To assess completeness of patient capture, SQUAD entries were compared to a sample of charts returned to the Medical Records Department, and to a sample of entries in ward and operating room logbooks. Two-tailed binomial proportions with 95% CI were calculated from the comparative results of patient observations, against a predefined accuracy of 0.85-0.95. RESULTS: Agreement between completed validation observations from charts and SQUAD data was 91.5% (n = 3734/4080 data points). Binomial tests indicated that 15 variables had higher than 95% accuracy. A total 19 of 24 variables had ≥ 85% accuracy. The completeness of SQUAD patient capture was 98.2% (n = 167/170) of charts returned to the Medical Records Department, 97.5% (n = 198/203) of operating logbook entries, and 100% (n = 111/111) of ward logbook entries, respectively. CONCLUSION: SQUAD closely reflects the primary surgical and anaesthetic data at a Ugandan secondary hospital. Data accuracy of key variables and completeness of population capture were comparable to those of databases in high-income countries and outperformed those of other low- and middle-income countries.

A Randomized Controlled Trial of Enhanced Recovery After Surgery Versus Standard of Care Recovery for Emergency Cesarean Deliveries at Mbarara Hospital, Uganda.

BACKGROUND: Enhanced recovery after surgery (ERAS) expedites return to patient baseline and functional status by reducing surgical trauma, stress, and organ dysfunction. Despite the potential benefits of enhanced recovery protocols, limited research has been done in low-resource settings, where 95% of cesarean deliveries are emergent and could possibly benefit from the application of ERAS protocols. METHODS: In a prospective, randomized, single-blind, controlled trial, mothers delivering by emergency cesarean delivery were randomly assigned to either an ERAS or a standard of care (SOC) recovery arm. Patients in the ERAS arm were treated with a modified ERAS protocol that included modified counseling and education, prophylactic antibiotics, antiemetics, normothermia, restrictive fluid administration, and multimodal analgesia. They also received early initiation of mobilization, feeding, and urethral catheter removal. The primary end point was length of hospital stay. The secondary end points were complications and readmission rates. Mean length of stay in the intervention and control arms were compared using t tests. Statistical analyses were performed using STATA version 13 (College Station, TX). RESULTS: A total of 160 patients were enrolled in the study, with 80 randomized to each arm. There was a statistically significant shorter length of stay for the ERAS arm compared to SOC, with a difference of -18.5 hours (P < .001, 95% confidence interval [CI], -23.67, -13.34). The incidence of complications of severe pain and headache was lower in the ERAS arm compared to SOC (P = .001 for both complications). However, pruritus was more common in the ERAS arm compared to SOC (P = .023). CONCLUSIONS: Use of an ERAS protocol for women undergoing emergency cesarean delivery in a low-income setting is feasible and reduces length of hospital stay without generally increasing the complication rate.