None listed
Conditions
Brief summary
Haemorrhoids are enlarged veins in the anus or lower rectum, which can cause bleeding, itching, pain and prolapse outside of the anal canal. The disease is commonly managed using rubber band ligation (RBL), where a band is placed around the base of the haemorrhoid, preventing blood flow to the haemorrhoid and causing it to fall off and pass through the anal canal. The most common complication of RBL is pain. Currently, surgeons vary widely in their approach to preventing pain in these patients, owing to a lack of quality evidence supporting one strategy over another. Surgeons may inject local anaesthetic at the site where the band is placed, or use it to block the nerve supplying the anus and lower rectum. Some patients receive no local anaesthetic, and rely on standard postoperative medications such as paracetamol, anti-inflammatories, and opioids. There is a need for quality research to determine the best strategy for pain management in patients undergoing this common procedure. In our study, participants undergoing RBL will be randomly assigned to receive either local anaesthetic at the banding site, a nerve block, or standard postoperative medications only. These pain management strategies are all routinely used in practice and are safe procedures common in many operations. At several timepoints following the procedure, participants will be asked to report their pain on a scale (up until 2 weeks post procedure). Participants’ use of pain medications in recovery; the time taken for participants to be discharged after their procedure; participant satisfaction with their procedure; the time it takes for participants to return to work after their procedure; and procedure associated complications, will also be recorded. These outcomes will then be used to determine which strategy is best for managing pain in patients undergoing RBL. We hypothesise that both pudendal nerve block and submucosal infiltration of local anaesthetic will be superior to no local anaesthetic for post-procedural pain management.
Interventions
This is a three-arm trial comparing submucosal local anaesthetic (LA) infiltration, pudendal nerve block (PNB) and standard care for analgesia in haemorrhoid banding.
Participants in the submucosal LA group will receive 1-2 mL of 0.5% bupivacaine with adrenaline (1:200,000) 2.5 mg/mL injected in the submucosal plane just proximal to the placement of the rubber band, intra-procedure, immediately prior to placement of the band.
Participants in the PNB group will receive 20mL ropivacaine 1% 10m
This is a three-arm trial comparing submucosal local anaesthetic (LA) infiltration, pudendal nerve block (PNB) and standard care for analgesia in haemorrhoid banding. Participants in the submucosal LA group will receive 1-2 mL of 0.5% bupivacaine with adrenaline (1:200,000) 2.5 mg/mL injected in the submucosal plane just proximal to the placement of the rubber band, intra-procedure, immediately prior to placement of the band. Participants in the PNB group will receive 20mL ropivacaine 1% 10mg/mL injected at the pudendal nerve on the ipsilateral side of the haemorrhoid to be banded, administered using anatomic landmarks, intra-procedure, immediately prior to placement of the band (if haemorrhoid disease is bilateral, then the block will be administered bilaterally). To standardise technique, the nerve block will be administered with the aid of an instructional video, which will be distributed to all participating proceduralists. All proceduralists will be consultant surgeons experienced in the administration of local anaesthetic in colorectal procedures. The rubber band ligation procedure typically takes 5-10 minutes, depending on the number of haemorrhoids to be banded and the severity of the disease. Participants' operation reports and/or medical records will be reviewed to monitor adherence to the administration of the anaesthetic agent - all anaesthetic techniques used in any procedure are routinely documented in medical records. Both these interventions are routinely used at the participating study sites in RBL procedures. The decision to opt for one analgesic strategy over another for an isolated RBL procedure in the population eligible for this study is proceduralist dependent; therein lies the clinical equipoise for this study. Accordingly, this trial does not involve the use of unapproved therapeutic goods or procedures.
Sponsors
Mr David Proud
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for this study are: - Adults aged 18 years or older, AND - Consented for rubber band ligation of haemorrhoid disease
Exclusion criteria
Exclusion criteria are: (1) previous reaction to the LA agents used in this study (i.e. ropivacaine, bupivacaine); (2) additional anorectal conditions (e.g. Crohn’s disease, anal fissure); or (3) receiving RBL in conjunction with another major interventional procedure. Patients will remain eligible if they undergo minor interventional procedures (e.g. polypectomy) or non-interventional procedures (e.g. colonoscopy).
Outcome results
None listed