Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201801002840239 Date of Approval: 05/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pudendal nerve block versus spinal anesthesia in hemorrhoidectomy
Official scientific title Pudendal Nerve Block and Spinal (SADDLE) Anesthesia in Haemorroidectomy
Brief summary describing the background and objectives of the trial Background: Pain is one of the main postoperative complications that extend the patient¿s period in the postoperative care unit. Pain after discharge from hospital is related to the level of pain immediately after the surgery and, therefore, the target is to eliminate pain in the recovery period. Perineum is an extremely sensitive region and the surgical removal of hemorrhoid causes painful stimuli, which remains for several days, with pain relief bringing evident benefits. Functional disorders of the rectum, bladder and sexual issues are caused not only by the surgery, but also by the insufficient treatment of postoperative pain. (50). We hypotheised In our study, that pudendal nerve block allow for better analgesia & less hospital stay & more patient satisfaction than saddle block. Methodology: We conducted a randomized controlled comparative prospective study in which half the patients received Saddle block & the other half received pudendal Nerve Block. The duration of analgesia, patient satisfaction, rate of success, rate of occurance of complications & time till discharge was recorded Results: Analgesia due to block of pudendal nerves lasted between 2 to 24 hours without rescue analgesic in 66% of the patients. In the saddle Group, duration of analgesia ranged between 2 to 10 hours only and almost all patients required rescue analgesic. Conclusion: the combination of general anesthesia (GA) and a bilateral pudendal nerve block(PNB), using local anesthetics, was found to substantially reduce postoperative pain, consumption of analgesics and pain at first defecation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Heamorroide
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 05/09/2016
Actual trial start date 04/10/2016
Anticipated date of last follow up 31/08/2017
Actual Last follow-up date 10/10/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomization sealed opaque envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group bilateral pudendal nerve block 5 ml 0.25% Bupivacaine 12 hours Induction of general anesthesia was conducted by attended anesthesiologist using 2mg/kg propofol and 2mic/kg Fentanyl then a laryngeal mask airway was inserted and isoflurane 2.5% inhalational was used for maintainance. The patient was then put in lithotomy position & A pararectal approach was used; the desired position of the puncture point was at the top of the ischial spine. Following aseptic 25
Control Group spinal anesthesia for hemorrhoidectomy 1.5 ml of bupivicaine was injected intrathecally 12 hours The patient was asked to set down for obtaining a siitting position. After sterilization of the back of the patient with Povidone-iodine (Betadine) the midline or paramedian approach was used for spinal saddle anesthesia, A spinal needle (25) G (B-Braun) advanced from skin through the deeper structures until two "pops" are felt. Successful dural puncture is confirmed by withdrawing the stylet to v 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
· ASA physical status I, II. · Age between 20-50 years old. · Body mass index (BMI) less than 30 kg/m2 · Patients with history of relevant local anesthetics allergy. · Patients using analgesics regularly for underlying disease such as arthritis. · Patients with coagulation disorders. · Infection at the site of injection. · Refusal of consent.¿ 20 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/07/2016 Anesthesia department faculty of medicine Cairo university
Ethics Committee Address
Street address City Postal code Country
27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of postoperative analgesia - 1st hour postoperative - 3rd hour postoperative - 5th hour postoperative - 7th hour postoperative - 9th hour postoperative - 11th hour postoperative - 13th hour postoperative - 15th hour postoperative - 17th hour postoperative - 19th hour postoperative - 21st hour postoperative
Secondary Outcome Hospital stay - 1st day - 2nd day
Secondary Outcome Pain at first defecation (VAS). First defecation
Secondary Outcome The total dose of morphine used as rescue analgesia during the 1st 24 hours. 1st 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr el ainy university hospital 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no fund
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasr el ainy hospital 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed Mohammed abdulhaq zahraa el maadi Cairo 11742 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Abd Elhaq mohamedabdelhaq76@hotmail.com 0201000053764 zahraa elmaadi
City Postal code Country Position/Affiliation
cairo 11764 Egypt Ass professor
Role Name Email Phone Street address
Public Enquiries mahmoud elbadry avicen22@gmail.com 01001107173 zahraa elmaadi
City Postal code Country Position/Affiliation
cairo 11562 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Enas Elshazly avicen2000@hotmail.com 01009001515 zahraa el maadi
City Postal code Country Position/Affiliation
cairo 11764 Egypt Professor of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information